BOSTON--(BUSINESS WIRE)--PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the “Company”), a clinical-stage biotherapeutics company dedicated to changing the treatment paradigm for devastating diseases, today reported on the key progress made across its Wholly Owned Programs1 and Founded Entities2 in 2022. Daphne Zohar, Founder and Chief Executive Officer of PureTech, commented: “2022 has been a particularly successful and productive year in both crystallizing value and shaping the future of PureTech. Our primary focus is to progress our Wholly Owned Pipeline to commercialization and deliver new classes of medicines for patients with serious, debilitating conditions. We are advancing toward this goal by deepening our commitment to programs with compelling clinical data that are moving into late-stage studies and that we believe have the potential for broad impact. “Over the next 12 months, we anticipate multiple important catalysts that will further guide how we prioritize our pipeline, informing our decisions regarding which programs we will drive to commercial launches ourselves and which programs could be most successfully advanced through other avenues such as a partnership, sale, or spinout into another entity.” PureTech’s Wholly Owned Programs are centered on developing breakthrough medicines for patients with underserved and serious diseases. The Company’s therapeutic candidates are being advanced for the potential treatment of devastating conditions including idiopathic pulmonary fibrosis (IPF), metastatic solid tumors, leukemia and certain neurological and neuropsychological indications. Additionally, PureTech’s Founded Entities are advancing 20 therapeutics and therapeutic candidates, of which two (Plenity® for weight management3 and EndeavorRx® for treating inattention in ADHD ages 8-124) have received both U.S. FDA clearance and European marketing authorization and a third (KarXT for schizophrenia) will soon be filed for FDA approval, as of the most recent update by the company. Key highlights include the following: Key Wholly Owned Program Updates LYT-100 (deupirfenidone) is in development for the potential treatment of conditions involving inflammation and fibrosis, including IPF, for which current standards of care are associated with significant tolerability issues, resulting in approximately three out of four patients in the U.S. foregoing treatment with these otherwise efficacious medicines.5 LYT-100 is a deuterated form of one of these treatments, pirfenidone, which has proven efficacy and has been shown to improve survival in these patients by approximately three years, but its side effects cause patients to discontinue or dose reduce, thereby limiting its effectiveness.6 Announced results from a randomized, double-blind crossover study in healthy older adults demonstrating that approximately 50% fewer subjects treated with PureTech’s LYT-100 experienced gastrointestinal-related adverse events compared to subjects treated with pirfenidone. Initiated a global, randomized double blind placebo-controlled trial of LYT-100 in patients with IPF. This trial is expected to serve as the first of two registration-enabling trials, and topline results are expected by the end of 2023. Initiated a preclinical study of LYT-100 for the prevention and treatment of radiation induced fibrosis, an indication for which the United States government stockpiles medical countermeasures. This program is subject to the
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