PureTech Health PLC PureTech Forms IPF Clinical Advisory Board

TIDMPRTC

PureTech Health PLC

12 May 2021

12 May 2021

PureTech Health plc

PureTech Forms Clinical Advisory Board for Idiopathic Pulmonary Fibrosis and Related Lung Disorders

Leading experts in the field will advise on clinical development of PureTech's lead, wholly-owned product candidate, LYT-100, in idiopathic pulmonary fibrosis and other progressive fibrosing interstitial lung diseases

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 (R) ) and nintedanib (Ofev (R) ). 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 [1] . 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.

About LYT-100

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.

About PureTech Health

PureTech is a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, including inflammatory, fibrotic and immunological conditions, intractable cancers, lymphatic and gastrointestinal diseases and neurological and neuropsychological disorders, among others. The Company has created a broad and deep pipeline through the expertise of its experienced research and development team and its extensive network of scientists, clinicians and industry leaders. This pipeline, which is being advanced both internally and through PureTech's Founded Entities, is comprised of 26 therapeutics and therapeutic candidates, including two that have received FDA clearance and European marketing authorization, as of the date of PureTech's most recently filed Annual Report on Form 20-F. All of the underlying programs and platforms that resulted in this pipeline of therapeutic candidates were initially identified or discovered and then advanced by the PureTech team through key validation points based on the Company's unique insights into the biology of the brain, immune and gut, or BIG, systems and the interface between those systems, referred to as the BIG Axis.

For more information, visit www.puretechhealth.com or connect with us on Twitter @puretechh.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that are or may be forward-looking statements, including statements that relate to the company's future prospects, developments, and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks and uncertainties that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, our expectations regarding the potential therapeutic benefits of LYT-100 including its comparative advantages over and potential to replace the current standard of care for IPF, our expectations regarding the development, design and advancement of LYT-100, our expectations regarding the formation of our new Clinical Advisory Board and those risks and uncertainties described in the risk factors included in the regulatory filings for PureTech Health plc. These forward-looking statements are based on assumptions regarding the present and future business strategies of the company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, neither the Company nor any other party intends to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.

Esbriet(R) is a registered trademark of Genentech, Inc. and Ofev(R) is a registered trademark of Boehringer Ingelheim International GmbH. Neither is owned by or affiliated with PureTech Health.

 
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[1] Cottin, V., Koschel, D., Günther, et al. (2018). Long-term safety of pirfenidone: Results of the prospective, observational PASSPORT study. ERJ Open Research, 4(4), 00084-2018. doi:10.1183/23120541.00084-2018

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May 12, 2021 07:00 ET (11:00 GMT)