PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the “Company”), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, today announced the formation of its Clinical Advisory Board for idiopathic pulmonary fibrosis (IPF) and other progressive fibrosing interstitial lung diseases (PF-ILDs). Comprised of physicians and researchers with deep expertise in the clinical development of novel therapies in PF-ILDs, the advisory group will work closely with PureTech as it advances LYT-100 (deupirfenidone).
“We are proud to have assembled some of the world’s leading experts in fibrosing lung diseases. These dedicated individuals have pioneered the research and development of the current standards of care for the treatment of fibrosing lung diseases, and they share our commitment to bringing novel therapeutics to these patients with significant medical needs,” said Daphne Zohar, Founder and Chief Executive Officer of PureTech. “Progressive fibrosing interstitial lung diseases impact approximately 200,000 patients in the United States alone, yet currently available treatment options have significant tolerability issues and dose-limiting toxicities. We believe LYT-100 has the potential to treat a wide array of these conditions, including IPF, and the advisory board’s guidance will help us advance LYT-100.”
Members of the Clinical Advisory Board include:
- Bill Bradford, M.D., Ph.D., is a biopharma advisor with broad expertise in drug development. Dr. Bradford, formerly Senior Vice President, Clinical Development at InterMune, successfully developed pirfenidone for the treatment of IPF.
- Vincent Cottin, M.D., is a Professor of Respiratory Medicine at Université Claude Bernard Lyon and Coordinator of the National Coordinating Reference Center for Rare Pulmonary Diseases at Louis Pradel Hospital, Hospices Civils de Lyon, Lyon, France. Dr. Cottin is a pioneer in the clinical care and research of patients with rare and orphan lung diseases and is currently the Section Editor of the European Respiratory Journal for interstitial lung diseases (ILDs).
- Kevin Flaherty, M.D., is a Professor at the University of Michigan specializing in IPF and other ILDs. Dr. Flaherty is the lead author of a study published in the New England Journal of Medicine titled, “Nintedanib in Progressive Fibrosing Interstitial Lung Diseases,” which was a Phase 3 trial of nintedanib in patients with fibrosing lung disease.
- Toby Maher, M.D., Ph.D., is a Professor of Clinical Medicine and Director of Interstitial Lung Disease at Keck School of Medicine of the University of Southern California. Dr. Maher is the principal investigator of PureTech’s LYT-100 study in Long COVID and was the lead author of research published in Lancet Respiratory Medicine discussing results of the Phase 2 trial of pirfenidone in patients with unclassifiable PF-ILDs.
- Paul Noble, M.D., is Chair of the Department of Medicine at Cedars-Sinai Medical Center and a noted researcher in lung inflammation and fibrosis. Dr. Noble is the lead author of a study in The Lancet analyzing the results of two late-stage studies evaluating the effect of pirfenidone on lung deterioration in patients with IPF.
- Marlies Wijsenbeek, M.D., Ph.D., is a pulmonary physician at the Erasmus Medical Center in Rotterdam, Netherlands, and Chair of the center’s multidisciplinary programs in ILDs. Dr. Wijsenbeek is the lead investigator on an international observational study to identify disease progression and evaluate the efficacy of home monitoring in patients with newly diagnosed fibrosing ILDs.
IPF is a fatal disease characterized by a progressive and irreversible decline in lung function. There are only two FDA-approved agents indicated to treat IPF: pirfenidone (Esbriet®) and nintedanib (Ofev®). While clinically effective, pirfenidone is associated with significant tolerability complications that hamper treatment compliance in approximately 50 percent of patients who begin therapy, resulting in sub-optimal disease management. LYT-100 is a selectively deuterated form of pirfenidone that has been shown to maintain the anti-inflammatory and anti-fibrotic properties of the parent compound while demonstrating a favorable pharmacokinetic (PK) profile. Accordingly, PureTech is developing LYT-100 to offer a differentiated safety profile compared to current standard of care drugs, which may support improved patient compliance while retaining or exceeding efficacy. PureTech is currently planning registration-enabling studies with LYT-100 in IPF and related PF-ILDs.
“IPF causes irreversible scarring of the lungs, which worsens over time and makes it difficult for patients to breathe. Despite the currently available treatments, the prognosis for IPF remains poor, and there is a substantial need for therapeutics that can make a meaningful difference for patients,” said Dr. Maher. “LYT-100 has a desirable tolerability and PK profile and has shown promising potential for this underserved patient population. I look forward to helping to advance LYT-100 as a member of PureTech’s Clinical Advisory Board.”
In addition to developing LYT-100 for the treatment of PF-ILDs, PureTech has commenced two clinical trials evaluating this therapeutic candidate in other indications. These include: 1) a global Phase 2 trial in adults with Long COVID respiratory complications and related sequelae and 2) a Phase 2a proof-of-concept study in patients with breast-cancer related, upper limb secondary lymphedema.
LYT-100 is PureTech’s most advanced wholly-owned therapeutic candidate. A deuterated form of pirfenidone, an approved anti-inflammatory and anti-fibrotic drug, LYT-100 is being advanced for the potential treatment of conditions involving inflammation and fibrosis, including lung disease (e.g., IPF and potentially other PF-ILDs and Long COVID respiratory complications and related sequelae), and disorders of lymphatic flow, such as lymphedema. PureTech completed a Phase 1 multiple ascending dose and food effect study evaluating LYT-100 in healthy volunteers and found it to be well-tolerated at all doses tested. PureTech is evaluating LYT-100 in a Phase 2 trial as a potential treatment for Long COVID respiratory complications and related sequelae as well as in a Phase 2a proof-of-concept study in patients with breast cancer-related, upper limb secondary lymphedema. PureTech is also advancing LYT-100 for the treatment of IPF and potentially other PF-ILDs and is planning registration-enabling studies.