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PureTech will initiate a registration authorization study for LYT-100 to treat IPF through a simplified 505(b)(2) development pathway, including a dose range study for patients with IPF and a phase 3 study for patients with IPF
Senior IPF and lung drug development expert, Paul Ford, MD, Ph.D, joined PureTech as Senior Vice President of Clinical Development, leading the project
PureTech Health plc (Nasdaq:PRTC, LSE: PRTC)) (“PureTech” or “Company”), a clinical-stage biotherapeutics company dedicated to the discovery, development and commercialization of highly differentiated drugs for destructive diseases, today announced a random, double The results of the blind crossover study proved that healthy elderly people who received PureTech’s LYT-100 (despirfenidone) had gastrointestinal (GI) related compared with those who received pirfenidone The number of adverse events (AE) decreased by approximately 50% (17.4% and 34.0%). Pirfenidone is approved by the US Food and Drug Administration (FDA) for the treatment of idiopathic pulmonary fibrosis (IPF), a chronic progressive orphan disease that causes significant morbidity and mortality. Based on these results, additional data generated by PureTech’s powerful LYT-100 clinical program, and recent regulatory feedback, the company intends to advance LYT-100 to the late-stage clinical development of the treatment of IPF, starting with a study to evaluate the dose range of six drugs in 2022 The LYT-100 treatment started for several months in the first half of the year. PureTech believes that the results of this study, together with Phase 3 studies, can be used as the basis for registration in the United States
LYT-100 is a selectively deuterated form of pirfenidone, designed to retain the effective and clinically proven anti-fibrosis and anti-inflammatory activities of pirfenidone, with differentiated pharmacokinetic characteristics, and is transformed into Good tolerability, as evidenced by clinical studies from multiple human data. Pirfenidone is one of the two standard care therapies approved for IPF, and there is also nintedanib, both of which are effective but are associated with severe gastrointestinal tolerance issues.1,2 Tolerability issues related to pirfenidone resulted in treatment interruption and/or a dose lower than the FDA-approved three times a day (TID) 801 mg dose, thus limiting its effectiveness in patients with IPF.1
“In a recently completed study of healthy elderly people, the administration of LYT-100 resulted in a 50% reduction in the number of healthy elderly people experiencing gastrointestinal-related adverse events compared with pirfenidone. This emphasizes the solution of LYT-100. PureTech’s Chief Medical Officer Julie Krop, MD, said: “By providing more tolerable treatment options so that patients can continue to receive treatment, this is critical to addressing this serious disease, thereby addressing the major problems of IPF patients. Meet the demand. “Based on the proven biology and known clinical benefits of pirfenidone, the ability to pursue a 505(b)(2) development path for LYT-100 significantly reduces our risk of obtaining approval and may make this Important therapies are available for patients to use quickly. ”
According to a recently published observational study and independent market research, although it has been proven effective, only about 26% of IPF patients receive current standard care treatment.3 This indicates that the vast majority of IPF patients have not yet received treatment, and further supports the significant need for new and tolerable treatment options. A previous clinical study compared the dose of pirfenidone lower than the FDA-approved dose, and noted the dose-effect response. However, in IPF patients, whether higher doses than the marketed dose can achieve higher efficacy has not yet been obtained Fully explore. In the upcoming dose range study, PureTech also plans to study LYT-100 in patients with IPF, whose total drug exposure is higher than the currently approved dose of pirfenidone, to see if higher exposure will improve efficacy.
Toby Maher, Keck Professor of Medicine, M.D., M.D., and M.D., University of Southern California University of Southern California Academic Medical Center said: “In the process of fighting IPF, there is an urgent need for more effective treatments with fewer side effects. “LYT- 100 Based on a large amount of existing clinical and biological knowledge, combined with a new modification, it has now been clearly demonstrated that it can improve tolerance and thereby increase treatment compliance-both of which are effective in improving patients This chronic, gradual, and inevitable individual result is critically terminally ill. ”
This double-blind, randomized, crossover study evaluated the tolerability of LYT-100 550 mg TID and pirfenidone 801 mg TID in 49 healthy elderly 60-79 years old. This age group and…
The full story can be found on Benzinga.com
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