PureTech Secures Orphan Drug Designation for LYT-100, Advancing New Treatment Development

Written by Emily J. Thompson, Senior Investment Analyst

Source: Newsfilter

Updated: 5 days ago

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Source: Newsfilter

Orphan Drug Designation: PureTech Health announced that its LYT-100 has received Orphan Drug Designation from both the FDA and the European Commission, aimed at facilitating the development of therapies for rare diseases, highlighting the urgent need for effective treatments in this patient population.
Clinical Trial Results: In the ELEVATE IPF trial, patients receiving LYT-100 825 mg three times daily experienced a significantly slower decline in lung function, with a change in Forced Vital Capacity (FVC) of -21.5 mL at 26 weeks compared to placebo, indicating its potential in treating idiopathic pulmonary fibrosis.
Market Demand and Strategic Importance: With only about 25% of idiopathic pulmonary fibrosis patients having received treatment, the development of LYT-100 aims to address this unmet need, potentially providing more effective treatment options and enhancing the company's competitive position in the biopharmaceutical sector.
Future Development Plans: Celea Therapeutics plans to initiate the Phase 3 SURPASS-IPF trial in the first half of 2026 to compare LYT-100 with the existing therapy pirfenidone, which, if successful, could establish a pathway for potential market approval and further drive company growth.

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About PRTC

PureTech Health plc is a clinical-stage company dedicated to giving life to new classes of medicine to change the lives of patients with devastating diseases. The Company is engaged in the development of around 29 therapeutics and therapeutic candidates, including three that have been approved by the United States Food and Drug Administration. A number of these programs are advanced by the Company or its Founded Entities in various indications and stages of clinical development. Its primary programs include LYT-100 and LYT-200. Deupirfenidone (LYT-100) is being developed as a potential new standard of care (SOC) for the treatment of idiopathic pulmonary fibrosis (IPF). LYT-200 is an anti-galectin-9 monoclonal antibody (mAb) being developed for the treatment of hematological malignancies, including acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS), as well as solid tumors, including head and neck cancers, with a focus on metastatic disease.

About the author

Emily J. Thompson

Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.

PureTech Health to Participate in Healthcare Conference

4 hours agoBusinesswire

Executive Participation: PureTech Health's CEO Robert Lyne and Co-founder Eric Elenko will participate in the Leerink Partners Global Healthcare Conference on March 11, 2026, showcasing the company's innovations in biotherapeutics.
Webcast Availability: The presentation will be available via webcast on PureTech Health's investor website, ensuring that investors and the public can access the latest updates in real-time.
Company Strategy Overview: PureTech Health is dedicated to developing therapeutics through a capital-efficient R&D model, having successfully launched three products approved by the U.S. FDA, demonstrating its potential in the biotherapeutics sector.
Cautionary Forward-Looking Statements: The press release includes forward-looking statements, highlighting the risks and uncertainties that may affect the company's future plans and strategies, advising investors to consider relevant risk factors.

PureTech Secures Orphan Drug Designation for Deupirfenidone in IPF Treatment

5 days agoBusinesswire

Orphan Drug Designation: PureTech Health announced that its deupirfenidone (LYT-100) has received Orphan Drug Designation from both the FDA and European Commission for treating idiopathic pulmonary fibrosis (IPF), highlighting the drug's potential to address significant unmet medical needs in this rare disease.
Clinical Trial Results: In the global Phase 2b ELEVATE IPF trial, participants receiving deupirfenidone 825 mg three times daily experienced a significantly slower decline in lung function, with a 26-week FVC change of -21.5 mL compared to -112.5 mL for placebo, demonstrating the drug's superior efficacy.
Future Research Plans: Celea Therapeutics intends to initiate the Phase 3 SURPASS-IPF trial in the first half of 2026, comparing deupirfenidone to the existing treatment pirfenidone, with successful results potentially providing critical data for drug registration.
Broad Market Potential: As a next-generation antifibrotic, deupirfenidone may set a new standard of care for IPF and has potential applications in other fibrotic diseases, further solidifying PureTech's leadership in the biotherapeutics sector.