Press Releases

-Lead candidate NT-0796 achieves positive interim results from Phase 1 study, supporting further progression for the treatment of a range of inflammatory diseases-

-Second lead candidate NT-0249 advances into first-in-human Phase 1 study to enable clinical development in peripheral chronic inflammatory disease-

-Third candidate NT-0527 is announced as a novel brain-penetrant NLRP3 inflammasome inhibitor advancing through IND-enabling studies-

LEXINGTON, MA – May 10, 2022 – NodThera, a clinical-stage biotechnology company developing a new class of potent and selective oral, small molecule NLRP3 inflammasome inhibitors to treat diseases driven by chronic inflammation, today announced several key advancements across the portfolio. NodThera’s lead candidate, NT-0796, demonstrated positive interim results from its Phase 1 single-ascending dose (SAD) study. Additionally, the company has commenced first-in-human dosing in the Phase 1 study of its second lead candidate, NT-0249, and announced the selection of its third pipeline candidate, NT-0527 – a brain-penetrant NLRP3 inflammasome inhibitor from a novel chemotype.

The positive interim results from the SAD portion of the Phase 1 trial with NT-0796 represent early clinical proof-of-mechanism for NT-0796 as a potent NLRP3 inflammasome inhibitor. Across all dosing cohorts, NT-0796 was safe and well tolerated and shown to be orally bioavailable with a dose-proportional pharmacokinetic (PK) profile. This portion of the study also showed a dose-dependent pharmacodynamic (PD) effect through the ability to lower IL-1β and IL-18 levels in an ex vivo NLRP3-stimulation assay. These results confirm the criteria to advance NT-0796 further in development and continue the ongoing multiple-ascending dose (MAD) portion of the Phase 1 study to assess brain exposure through cerebrospinal fluid (CSF) sampling.

“NT-0796 has demonstrated robust proof of mechanism and translation from preclinical studies to humans, both validating and further de-risking the development of NT-0796 as a potentially best-in-class, oral, small molecule NLRP3 inflammasome inhibitor,” said NodThera’s Chief Executive Officer, Adam Keeney. “We are encouraged by these first-in-human results as we work to progress NT-0796 in inflammatory diseases impacting millions of patients, many with limited to no treatment options.”

Building on successful clinical progress with NT-0796, NodThera has also initiated dosing of the first healthy volunteers in the Phase 1 trial of the company’s second lead candidate, NT-0249. NT-0249 is a potent inhibitor of the NLRP3 inflammasome with favorable development characteristics supporting advancement to treat chronic inflammatory diseases of the body. The primary objective of this study will be to assess the safety and tolerability of NT-0249, with secondary objectives to assess the PK and PD (ability to lower IL-1β and IL-18 levels) after single and multiple ascending doses.

In addition to advancing two novel candidates into clinical trials, NodThera is further expanding its diverse portfolio with the announcement of NT-0527 as the third oral small molecule NLRP3 inflammasome inhibitor from a novel chemotype to be added to its pipeline. NT-0527 is uniquely designed to inhibit the NLRP3 inflammasome in the brain, with potential to treat a broad range of neuroinflammatory diseases.

“Each of NodThera’s three portfolio candidates feature unique chemotypes that are distinct from one another, offering specific benefits that can be collectively used to cover a range of inflammatory diseases of the brain and body” shares NodThera’s Chief Scientific Officer, Alan Watt. “With the recent addition of NT-0527 as the third candidate in our growing pipeline, NodThera is now advancing novel CNS-penetrant and peripherally-restricted NLRP3 inflammasome inhibitors with differentiated chemistry unlike any other portfolio in the field.”

About NodThera

NodThera is a clinical-stage biotechnology company developing a new class of potent and selective NLRP3 inflammasome inhibitors for the treatment of diseases driven by chronic inflammation. Led by an experienced management team, NodThera is leveraging new insights into inflammasome biology and chemistry to build a portfolio of highly differentiated small molecule NLRP3 inflammasome inhibitors. The company was founded in 2016 by Epidarex Capital and financed by 5AM Ventures, Cowen Healthcare Investments, Epidarex Capital, F-Prime Capital, Novo Holdings, Sanofi Ventures and Sofinnova Partners. NodThera is headquartered in Lexington, MA, with additional locations in Cambridge, UK and Seattle, WA. Learn more at www.nodthera.com or follow us on LinkedIn.

Media Contact

Darby Pearson
Verge Scientific Communications
dpearson@vergescientific.com

-Study of lead candidate to provide important information on safety, pharmacokinetics and pharmacodynamics to inform further clinical development in chronic inflammatory diseases-

-Highlights continued progress advancing a differentiated portfolio of novel NLRP3 inflammasome inhibitors to treat both peripheral- and neuro- inflammatory diseases-

BOSTON and SEATTLE and CAMBRIDGE, England, Nov. 4, 2021 /PRNewswire/ — NodThera, a clinical-stage biotechnology company developing a new class of medicines that inhibit the NLRP3 inflammasome to treat chronic inflammation, today announced that the first healthy volunteers have been dosed in a Phase 1 clinical trial of its lead investigational candidate, NT-0796.

NT-0796 is a small molecule NLRP3 inflammasome inhibitor with differentiated novel chemistry that provides unprecedented potency and potential for prolonged pharmacodynamic (PD) effect, with the ability to cross the blood brain barrier in preclinical species. NT-0796 selectively inhibits NLRP3, the upstream regulator of the body’s inflammation response, to reduce levels of both IL-1β and IL-18 – pro-inflammatory cytokines known to play a role in chronic inflammation underlying a wide range of chronic diseases. Pharmacokinetic (PK) and PD data from an ex vivo IL-1β/IL-18 stimulation assay and cerebrospinal fluid (CSF) sampling in the Phase 1 study will inform further clinical development.

“The recent convergence of key insights into innate immunity, IL-1β/IL-18 and the NLRP3 inflammasome have revolutionized our understanding of chronic disease,” said Adam Keeney, Ph.D., CEO of NodThera. “As one of the first companies to recognize the importance of NLRP3 in the inflammation cascade, we look forward to gathering important human data from the Phase 1 clinical study of our lead candidate NT-0796 so we can accelerate innovation for patients with limited treatment options.”

The primary objective of this study is to assess the safety and tolerability of NT-0796, while secondary objectives include assessment of PK and PD (ability to lower IL-1β and IL-18 levels) and CSF sampling to assess NLRP3 target engagement and compound exposure after single and multiple ascending doses.

“NT-0796 leverages novel chemistry that is unlike any other NLRP3 inflammasome inhibitor in the field. It is designed to deliver key advantages in PK and PD, with the potential to cross the blood brain barrier,” said Donald Johns, M.D., Chief Medical Officer of NodThera. “The NLRP3 inflammasome is a key driver of diseases that span different parts of the body, from common ailments such as osteoarthritis, to cardiovascular disease, Alzheimer’s Disease, cancer, and beyond. Unlocking this treatment potential provides the opportunity to impact many patients whose quality of life is negatively affected by chronic inflammatory disease.”

About NodThera
NodThera is a clinical-stage biotechnology company developing a new class of potent and selective NLRP3 inflammasome inhibitors for the treatment of diseases driven by chronic inflammation. Led by an experienced management team, NodThera is leveraging new insights into inflammasome biology and chemistry to build a portfolio of highly differentiated small molecule NLRP3 inflammasome inhibitors. The company was founded in 2016 and financed by 5AM Ventures, Cowen Healthcare Investments, Epidarex Capital, F-Prime Capital, Novo Holdings, Sanofi Ventures and Sofinnova Partners. NodThera is headquartered in Lexington, MA, with additional locations in Cambridge, UK and Seattle, WA. Learn more at www.nodthera.com or follow us on LinkedIn.

Strengthens senior leadership team with appointments of Donald Johns, M.D., as Chief Medical Officer and Katina Dorton, J.D., MBA, as Chief Financial Officer

CAMBRIDGE, UK, BOSTON and SEATTLE – December 15, 2020 – NodThera, a biotechnology company developing a new class of medicines that inhibit the NLRP3 inflammasome to treat chronic inflammation, today announced the expansion of its senior leadership team with the appointments of Donald Johns, M.D., as Chief Medical Officer and Katina Dorton, J.D., MBA, as Chief Financial Officer.

Dr. Johns is an accomplished drug development leader and board-certified clinical neurologist who previously served as Chief Medical Officer and Executive Vice President of Medical and Scientific Affairs at Syntimmune, prior to the company’s acquisition by Alexion Pharmaceuticals. Ms. Dorton is a recognized and internationally experienced financial executive, corporate director and public company CFO. Ms. Dorton’s industry expertise includes roles in healthcare, life sciences and investment banking, including experiences at Repare Therapeutics and AVROBIO, Inc.

NodThera is advancing a portfolio of potent and selective inhibitors of the NLRP3 inflammasome that reduce both IL-1β and IL-18, pro-inflammatory cytokines which are known to play a role in chronic inflammation underlying a wide range of diseases. The pipeline includes brain penetrant NLRP3 inhibitors for central nervous system (CNS) indications.

“We welcome Don and Katina to the team as we continue to advance our portfolio of differentiated NLRP3 inhibitors to capitalize on the opportunity to exploit the well-understood, but still untapped therapeutic potential of the NLRP3 inflammasome across a broad spectrum of diseases,” said Adam Keeney, Ph.D., President & Chief Executive Officer of NodThera. “Don is an accomplished clinician with an impressive track record who brings a wealth of innovative clinical development experience. Katina brings capital markets experience and has built financial, legal and operational functions to support companies through aggressive growth, including IPO preparation. Their combined contributions will add significant value as we continue to advance NodThera’s portfolio through clinical development and additional financing rounds.”

“The NLRP3 inflammasome is one of the most exciting emerging areas of therapeutic science. NodThera’s best-in-class molecules have great potential to address the unmet medical need in patients with a wide range of inflammatory disorders,” said Dr. Johns. Ms. Dorton adds, “By leveraging innate immunity, NodThera’s platform has the potential to blaze a new path forward in a wide range of disorders, and I am excited to join the rest of the experienced leadership team in this effort.”

Dr. Johns brings more than 25 years of experience in the development of novel treatments for serious diseases, including autoimmune and CNS disorders. Prior to his role at Syntimmune, Dr. Johns served in key leadership positions at Biogen and the Novartis Institutes for Biomedical Research (NIBR). He has contributed to numerous investigational new drug applications (INDs), first-in-human studies and conclusive proof-of-concept studies in a broad spectrum of CNS and autoimmune diseases, as well as four successful new drug applications (NDAs). Prior to joining the pharmaceutical industry, he was a neurologist clinician-scientist at Johns Hopkins and Harvard Medical School. Dr. Johns earned his B.A. from Vanderbilt University and his M.D. from the Yale University School of Medicine.

Ms. Dorton currently serves on the board of directors for Fulcrum Therapeutics (Nasdaq: FULC), Pandion Therapeutics, Inc. (Nasdaq: PAND) and US Ecology (Nasdaq: ECOL). She most recently served as Chief Financial Officer of Repare Therapeutics, a synthetic lethality and DNA repair-focused oncology company. Prior to Repare, Ms. Dorton served as Chief Financial Officer of AVROBIO, a lentiviral gene therapy company. Earlier in her career, she served as a managing director in investment banking for Morgan Stanley and Needham & Company and as an associate attorney at Sullivan & Cromwell. Ms. Dorton received her J.D. from the University of Virginia School of Law, her MBA from George Washington University and her B.A. from Duke University.

About NodThera

NodThera is a biotechnology company developing a new class of potent and selective NLRP3 inflammasome inhibitors for the treatment of diseases driven by chronic inflammation. Led by an experienced management team, NodThera is leveraging new insights into inflammasome biology and chemistry to build a platform of highly differentiated small molecule NLRP3 inhibitors. The company was founded by Epidarex Capital and further financed by 5AM Ventures, Cowen Healthcare Investments, F-Prime Capital, Novo Holdings, Sanofi Ventures and Sofinnova Partners. NodThera was founded in 2016 and maintains offices in Cambridge, UK, Seattle, WA and Boston, MA. For more information please visit www.nodthera.com.

Media Contact

Gina Nugent
Ten Bridge Communications
(617) 460-3579
gina@tenbridgecommunications.com

Financing round led by Novo Holdings and includes new investors Cowen Healthcare Investments and Sanofi Ventures, as well as existing investors 5AM Ventures, F-Prime Capital, Sofinnova Partners and founding investor Epidarex Capital

Proceeds to support advancement of pipeline of small molecule NLRP3 inflammasome inhibitors, including continued progression of NT-0167 through clinical development

CAMBRIDGE, UK, BOSTON & SEATTLE – June 3, 2020 – NodThera, a clinical stage biotechnology company developing a new class of medicines that inhibit the NLRP3 inflammasome to treat diseases driven by chronic inflammation, today announced that it has secured $55 million (£44 million) in a Series B financing. NodThera’s lead candidate, NT-0167, is being evaluated in a Phase 1 clinical trial in healthy volunteers.

“Millions of people live with diseases in which chronic inflammation plays a role,” said Nanna Lüneborg, Partner, Novo Ventures. “NodThera’s approach to selectively target the NLRP3 inflammasome without broadly suppressing the immune system is an enormously promising strategy for developing therapies that can help these patients.”

Proceeds from the financing will be used to advance NT-0167 through clinical studies, further progress the development of additional compounds — including brain-penetrant NLRP3 inflammasome inhibitors for central nervous system indications — and continued drug discovery efforts.

“The NLRP3 inflammasome is one of the most exciting emerging areas of drug discovery. Therapeutics that disrupt the NLRP3 inflammasome to inhibit damaging inflammatory processes have the potential to help patients with many chronic diseases,” said Henrijette Richter, Managing Partner at Sofinnova Partners. “NodThera has distinguished their science in a field that holds huge promise and we look forward to the company’s further progress.”

The first-in-human clinical study for NT-0167 is evaluating the candidate for safety and tolerability as well as pharmacokinetic and pharmacodynamic response. In preclinical studies, NT-0167 demonstrated potent and selective inhibition of the NLRP3 inflammasome resulting in reductions of IL-1β and IL-18, pro-inflammatory cytokines which are known to play a key role in chronic inflammation underlying a wide range of diseases.

“Continued advancement of our lead molecule through clinical development represents a significant achievement in our work to exploit the still untapped therapeutic potential of selectively targeting the NLRP3 inflammasome,” said Adam Keeney, President and Chief Executive Officer of NodThera. “This financing from a world-class syndicate of life science investors speaks to the significant potential of our pipeline.”

Joining the NodThera Board as part of this Series B financing will be Nanna Lüneborg, Partner at Novo Ventures, Kevin Raidy, Managing Partner at Cowen Healthcare Investments and Alex Pasteur, Partner at F-Prime Capital.

About NodThera

NodThera is a biotechnology company developing a new class of potent and selective NLRP3 inflammasome inhibitors for the treatment of diseases driven by chronic inflammation. Led by an experienced management team, NodThera is leveraging new insights into inflammasome biology and chemistry to build a platform of highly differentiated small molecule NLRP3 inhibitors. The company was founded by Epidarex Capital and further financed by 5AM Ventures, Cowen Healthcare Investments, F-Prime Capital, Novo Holdings, Sanofi Ventures and Sofinnova Partners. NodThera maintains offices in Cambridge, UK, Seattle, WA and Boston, MA.

For more information please visit www.nodthera.com.

Media Contact

Matthew Corcoran
Ten Bridge Communications
(617) 866-7350
mcorcoran@tenbridgecommunications.com

– Company advances NT-0167 as first development candidate from a broad platform of NLRP3 inflammasome inhibitors

– Appoints Don Nicholson as Board Chairman and Kevin Lee as Independent Director

CAMBRIDGE, UK, BOSTON and SEATTLE – April 10th, 2019 – NodThera, a biotechnology company developing a new class of medicines that inhibit the NLRP3 inflammasome to treat chronic inflammation, today announced that it has advanced its lead development candidate, NT-0167, into pre-IND testing as it prepares to advance to the clinic.

The company also announced that it has strengthened its Board of Directors with the addition of two industry leaders with deep experience developing novel treatments targeting compelling new areas of biology. Don Nicholson, Ph.D., former Chief Executive Officer of Nimbus Therapeutics, has joined the Board as Chairman, and Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics, has joined as an Independent Director.

“The field of NLRP3 inflammasome inhibitors is expanding rapidly, with new insights highlighting the role of innate immunity in driving the chronic inflammation that is at the root of a wide range of serious diseases,” said Adam Keeney, Ph.D., President and Chief Executive Officer of NodThera. “The progression of our first development candidate represents an important milestone as we advance rapidly toward the clinic. We are thrilled to welcome Don and Kevin to the Board and believe their strategic insights and deep experience in pioneering novel treatments across multiple disease areas will help us to build a truly transformational therapeutics company.”

NodThera is enhancing current understanding of innate immunity and the NLRP3 inflammasome’s role in chronic inflammation to develop a leading platform of small molecule therapeutics. The company has made significant progress over the past two years in shaping the second-generation chemistry platform that builds on the innovation of NT-0167.

Don Nicholson, Ph.D., joins the NodThera Board as Chairman after most recently serving as Chief Executive Officer of Nimbus Therapeutics. He previously spent 25 years at Merck, where he held strategic, leadership and operational roles across diverse therapeutic areas including inflammation, immunology and neuroscience. Dr. Nicholson began his career at Merck Frosst in Montreal as a Senior Research Biologist and held positions of increasing responsibility, including Vice President and Site Head of the Merck Neurosciences Research site in San Diego, Vice President of Immunology and Infectious Diseases and Vice President and Worldwide Discovery Head for the Bone, Respiratory, Immunology and Endocrine franchise in New Jersey. Dr. Nicholson is also a member of the Board of Directors of Kymera Therapeutics and Generation Bio and serves as Chair of the Board of Jnana Therapeutics.

“I am excited to join the Board of NodThera at a time of growing awareness about the therapeutic potential of NLRP3 inflammasome inhibitors and am impressed by the company’s tremendous progress in developing an approach capable of fully exploiting this opportunity,” said Dr. Nicholson. “NodThera’s differentiated knowledge and expertise position the company to push the field into new frontiers.”

Kevin Lee, Ph.D., MBA, has served as Chief Executive Officer of Bicycle Therapeutics since 2015. He previously served as Senior Vice President and Chief Scientific Officer of the Rare Disease Research Unit at Pfizer, where he led more than 20 novel research and development programs and oversaw strategy for rare diseases and gene therapy. Prior to joining Pfizer, Dr. Lee worked at GlaxoSmithKline (GSK), where he led epigenetics research and formed multiple strategic commercial and academic partnerships. Earlier in his career, he lectured at Warwick University Medical School and founded Cambridge Biotechnology (acquired by Biovitrum) and Neurosolutions.

– Expansion in the US is consistent with NodThera’s strategy to access world class talent, foster collaborative relationships and develop deep insights into inflammasome biology to drive diversified chemistry into the clinic

Cambridge, UK, Boston, MA and Seattle, WA, 23rd October 2018. NodThera, a biotechnology company focused on the discovery and development of next generation NLRP3 inflammasome inhibitors for the treatment of diseases driven by chronic inflammation, today announces the appointment of Alison Strutt PhD as Head of Finance & Operations and simultaneously launches its new corporate office in Boston, MA and laboratory in Seattle, WA.

Alison Strutt is a seasoned healthcare finance executive and joins NodThera from GlaxoSmithKline (GSK) where she held a number of senior finance roles including as Chief of Staff to the Chief Finance Officer. Alison has extensive transactional and operational experience and most recently was responsible for transforming GSK’s reporting processes.  Alison was also previously the CFO for the GSK’s Drug Discovery group where her remit spanned all therapeutic areas as well as establishing the Tres Cantos Open Lab and Catalyst Science Park at GSK’s UK R&D site.  Prior to working for GSK, Alison led the UK M&A Life Sciences Sector group at Deloitte.

NodThera’s CEO, Adam Keeney will be based in the new corporate office in Lexington, MA, which will be expanded to include medical affairs, business development, operations and the strategic financing organisation. It is located in the heart of Boston’s healthcare ecosystem and is well positioned to access Boston’s deep talent pool and foster collaborations with key investigators and future pharma partners to drive forward NodThera’s US development strategy.

The new laboratory in Seattle will be the centre of NodThera’s NLRP3 biology and inflammasome research and is where NodThera’s VP of Biology, Chris Gabel will be located.  NodThera plans to benefit from Chris’ deep experience in NLRP3 biology, complemented by the local scientific talent pool in Seattle which is home to both emerging and established life science organisations.

The office in Cambridge, UK will remain the headquarters of the Company and will focus on the leadership of all discovery efforts, including chemistry, biology and management of the CRO network for preclinical development.

Adam Keeney, President & CEO of NodThera, added: “Alison joins NodThera at a pivotal time in the Company’s development as we enter a period of growth and momentum. She brings with her significant strategic and financial experience in healthcare and I look forward to working with her in achieving our goal of bringing to the clinic multiple drug candidates across a range of chronic inflammatory indications”.

I am also pleased to announce both the opening of our corporate office in Boston and our biology lab in Seattle, both renowned healthcare hubs that will ensure we’re well positioned to access world-class talent, strengthen relations with key collaborators and to further consider our future financing and partnering strategy.”

Alison Strutt, Head of Finance & Operations of NodThera, added: “I am delighted to be joining NodThera at this exciting time. The Company has an innovative approach that aims to transform years of in-depth inflammasome research into a pipeline of high value clinical drug candidates and I look forward to working with the team to build a leading company in NLRP3 inflammasome inhibition.”

– Dr Keeney joins NodThera with over 20 years of pharmaceutical industry experience, including most recently at Sanofi and prior to that at Johnson & Johnson

Cambridge, UK and Boston, MA, 24 September 2018. NodThera, a biotechnology company focused on the discovery and development of next generation NLRP3 inflammasome inhibitors for the treatment of diseases driven by chronic inflammation, today announces the appointment of Adam Keeney PhD as President and Chief Executive Officer, with immediate effect. Adam will join the NodThera Board of Directors and will also establish a new office for the Company in the Boston, MA area. Alan Watt, who has been Chief Scientific Officer and acting as interim Chief Executive Officer of the Company since its inception, will now resume his role as full-time CSO.

Dr Keeney has over 20 years of international experience in the pharmaceutical industry. He joins NodThera from Sanofi Genzyme, where he served as Global Head of Sanofi Genzyme Business Development. In this role, he was responsible for leading all of Sanofi Genzyme’s business development activities, including early and late stage deals, supporting each of Sanofi’s specialty care therapeutic areas which include Immunology, Neurology, Oncology, Rare Diseases and Rare Blood Disorders. Dr Keeney was also Chair of the internal governance body that oversaw the review, prioritisation and execution of all external R&D investments, as well as management of the external research budget.

Previously, Dr Keeney worked at Johnson & Johnson where he held a number of roles with increasing responsibility eventually becoming Site Head of the Johnson & Johnson California Innovation Center, catalysing early stage innovation across J&J’s pharmaceuticals, medical devices and consumer businesses. Dr Keeney started his career as a research scientist at H. Lundbeck A/S. He holds a PhD in Neuropharmacology from the University of Nottingham, UK.

Henrijette Richter PhD, Managing Partner, Sofinnova Partners and Chair of the Board of Directors of NodThera, said: “Attracting a CEO of Adam’s calibre is a testament to the exciting potential of NodThera and its novel approach to creating treatments for a range of diseases driven by chronic inflammation. The broad applicability of NodThera’s product candidates requires a leadership team that has considerable expertise in leading a rapid development pathway and proactive and productive partnering and collaboration strategy. With the appointment of Adam today, the Board of NodThera strongly believes that a world-class management team has been established to guide NodThera through its next phase of growth.

“I would like to thank Alan for his excellent and dedicated work as interim CEO. He will now resume his role as CSO with the Company following a smooth transition to Adam.”

Adam Keeney PhD, President and Chief Executive Officer of NodThera, added: “Selective NLRP3 inflammasome inhibition is one of the most promising areas to treat diseases caused by chronic inflammation. I believe that NodThera’s next generation approach has the potential to bring new treatment options to patients across a wide range of therapeutic areas. With offices in both the UK and the US, NodThera is establishing a truly global business, well positioned to push the frontiers of inflammation research with access to the very best talent in the field. I am excited to be working together with our highly experienced management team, Scientific Advisory Board and our experienced international Board of Directors to establish NodThera as a world-leader in NLRP3 inflammasome inhibition.”

– NodThera discovers and develops next generation NLRP3 inflammasome inhibitors for the treatment of diseases driven by chronic inflammation

Cambridge, UK, 25 June 2018 – NodThera, a biotechnology company focused on the discovery and development of next generation NLRP3 inflammasome inhibitors for the treatment of diseases driven by chronic inflammation, today announces it has closed its Series A financing round for a total of £28 million ($40 million). The Series A second closing was co-led by leading healthcare investors Sofinnova Partners and 5AM Ventures, with further participation from Epidarex Capital and F-Prime Capital Partners. NodThera was created and seed funded by life science investor, Epidarex Capital in 2016 based on earlier research conducted at Selvita, a Polish drug discovery company which remains a shareholder in NodThera. Henrijette Richter, PhD, Managing Partner of Sofinnova Partners and Scott Rocklage, PhD, Founding Partner of 5AM Ventures will both join the Board of Directors with Henrijette Richter additionally serving as Chair.

Alan Watt PhD MBA, Chief Scientific Officer and acting Chief Executive Officer, said: “Selective NLRP3 inflammasome inhibition represents one of the most exciting and promising approaches to treating diseases caused by chronic inflammation. We believe this approach has the potential to transform the treatment of patients suffering from these diseases where there are limited or no treatment options available. NodThera is committed to discovering and developing first-in-class molecules in our core disease areas, and working with the best partners in this space to address other chronic inflammation driven therapeutic areas. Together with our highly experienced management team, a strong scientific advisory board and the support of our international blue-chip investors, we are fully equipped to achieve our future goals.”

NodThera is developing small molecule inhibitors of the NLRP3 inflammasome, a multi-protein complex which initiates an innate immune response in the body. NodThera’s next generation approach could bring new treatment options to patients in areas where current standard of care is sub-optimal or non-existent across a wide range of therapeutic areas related to chronic inflammation. The NodThera strategy is to develop its leading drug candidate through to proof-of-concept in humans in an inflammatory disease and to bring forward further drug candidates specifically addressing high unmet medical needs such as neurodegenerative diseases and certain cancers. NodThera’s team combines a deep understanding of NLRP3 inflammasome inhibition with extensive pharmaceutical experience of drug discovery and development and is supported by a world-class team of scientific advisors.

Henrijette Richter PhD, Managing Partner, Sofinnova Partners and Chair of the Board of Directors said: “We are excited to invest in NodThera who we believe have the ability to address a wide range of disease areas related to chronic inflammation. We are pleased to have co-led this next chapter in NodThera’s development and look forward to supporting the management team as it establishes NodThera as a world-leader in NLRP3 inflammasome inhibition.”

Elizabeth Roper PhD, Partner, Epidarex Capital, said: “Since its inception, we saw the potential for NodThera to become a pioneer in the NLRP3 inflammasome space with the right approach to produce ground breaking products targeting multiple therapeutics areas. We are delighted to welcome such an experienced and international group of investors into the Company and believe this is strong validation of NodThera’s ambitions.”

A pioneering new company based on Selvita research and utilizing novel immunological approaches to disease

Edinburgh, Scotland, July 28, 2016: Epidarex Capital today announces the launch of Nodthera Limited, a new biotech company focused on the discovery and development of novel inhibitors of the NLRP3 inflammasome. Nodthera is based on world class research conducted within Selvita S.A. (“Selvita”), an international drug discovery company, with offices in Boston, San Francisco, Cambridge, UK and Krakow, Poland. Nodthera will be headquartered in Edinburgh, Scotland.

Inflammasomes are large multiprotein complexes which assemble in a cell’s cytoplasm in response to environmental danger signals and are considered an essential part of an organism’s innate immune response. Activation of an inflammasome assembly leads to the release of pro-inflammatory cytokines, IL-1 and IL-18. Over-activation of the NRLP3 inflammasome is implicated in a wide range of diseases that are a substantial burden on modern healthcare systems such as type 2 diabetes, gout, rheumatoid arthritis, Alzheimer’s disease and cancer. Until recently, the NLRP3 inflammasome has been a difficult target. However, recent advances and insights from the scientific community has renewed and re- invigorated interest in targeting the NLRP3 inflammasome. Selective inhibition of the NLRP3 inflammasome rather than its downstream cytokines holds great therapeutic potential. Nodthera aims to become a key player in developing inhibitors of this protein complex.

Elizabeth Roper, PhD, a Partner at Epidarex Capital, led the deal and commented “Nodthera Limited has the potential to create first in class small molecule modulators of the NLRP3 inflammasome complex which could be a significant development in the field.” She further added, “Epidarex is delighted to be partnering with Selvita to bring this exciting science to market.”

“We are confident that Nodthera’s therapeutic approach is exceptional and addresses an important class of intracellular receptors implicated in variety of disorders with unmet medical needs. We’re excited to work with a partner such as Nodthera, who shares our vision and belief that in drug discovery joining forces and cooperation is the key to success.” – said Krzysztof Brzozka, PhD, Chief Scientific Officer at Selvita.

“As a limited partner in the fund, we are excited to have Epidarex invest in an opportunity to accelerate the development of a novel approach in this rapidly emerging area and potentially help patients with a wide range of diseases, including dementia where Lilly has 25 years of research and development experience,” said Johnston Erwin, Vice President of Corporate Business Development at Eli Lilly and Company.

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About Epidarex Capital

Epidarex Capital invests in early-stage, high growth life science and health technology companies in under-ventured markets within the UK and US. Epidarex was created to meet the need for more sector-specific risk capital for young companies, including spin-outs from leading research universities. The fund’s international management team has a track record of successfully partnering with top scientists and entrepreneurs to develop highly innovative products for the global healthcare market. For further information, please visit www.epidarex.com

About Selvita SA

Selvita is a drug discovery company engaged in the research and development of breakthrough therapies primarily in the area of oncology, as well as provision of integrated drug discovery services. Selvita was established in 2007 and currently employs over 340 people, including 111 PhDs, with extensive experience in the area of life sciences. Selvita has currently several projects at early or late discovery stage and is expected to move its first candidates to the clinic in 2016. Drug discovery clients of Selvita include more than fifty large and medium-sized pharmaceutical and biotechnology companies from USA and Europe. Selvita offices are located in Greater Boston Area, San Francisco Bay Area, Cambridge, UK, as well as in Krakow and Poznan, Poland. The company is listed on the Warsaw Stock Exchange (WSE:SLV). More information: www.selvita.com

This press release contains forward-looking statements about the investment of Epidarex Capital and various investors, including Eli Lilly and Company, in a biotech company focused on the discovery and development of novel inhibitors of the NLRP3 inflammasome. It reflects Lilly’s and Epidarex’s current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development. There is no guarantee Epidarex or Lilly will realize the expected benefits of the transaction, that the product will receive regulatory approval, or if approved, would be commercially successful. For further discussion of these and other risks and uncertainties, please see Lilly’s latest Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. The companies undertake no duty to update forward-looking statements.

For more information, please contact:

Anokhi Madhavji
Anokhi.Madhavji@plmr.co.uk
+44-7415 701567

Natalia Baranowska
natalia.baranowska@selvita.com
+48 784 069 418