Enrollment Complete in LYT-100 Phase 2b IPF Trial

A clinical-stage biotherapeutics firm, PureTech Health, has announced the completion of patient enrollment in a Phase 2b clinical trial for a drug candidate, LYT-100, intended for the treatment of idiopathic pulmonary fibrosis (IPF). IPF is a rare, progressively debilitating, and ultimately fatal lung disease, with a typical life expectancy of 2 to 5 years post-diagnosis. The current standard treatments, pirfenidone and nintedanib, have shown efficacy but are often not well-tolerated, leading to a significant number of patients opting not to pursue treatment.

LYT-100, a deuterated variant of pirfenidone, is being developed to maintain the therapeutic benefits of the original drug while offering improved pharmacokinetics and, crucially, better tolerability. This could potentially address the unmet needs of patients who struggle with the side effects of existing treatments. The Phase 2b ELEVATE IPF trial is set up as a randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and optimal dosing of LYT-100. The trial involves participants receiving either 550 mg or 825 mg of LYT-100, the standard dose of pirfenidone, or a placebo three times daily for a period of up to 26 weeks.

Previous crossover trial data indicated that the 550 mg dose of LYT-100 provided equivalent drug exposure to the FDA-approved 801 mg dose of pirfenidone, with a significant reduction in gastrointestinal and central nervous system adverse events. Furthermore, an 824 mg dose of LYT-100 demonstrated higher drug exposure and was well-tolerated, suggesting the possibility of improved efficacy and tolerability.

The primary goal of the ELEVATE IPF trial is to measure the rate of decline in Forced Vital Capacity (FVC) for LYT-100 compared to placebo over the treatment period, with additional endpoints focusing on tolerability, biomarkers, and patient-reported outcomes. The trial is not designed to prove statistical efficacy superiority over pirfenidone but aims to provide valuable data for the drug's development.

PureTech Health, through its extensive R&D efforts and collaborations, has a diverse pipeline of therapeutic candidates, with LYT-100 being one of the promising candidates that could redefine treatment options for IPF patients. The company's gratitude is extended to all those involved in the trial, emphasizing the importance of collaborative efforts in advancing medical research for severe diseases.

The development of LYT-100 is part of PureTech's mission to innovate and provide new classes of medicine that can significantly improve the quality of life for patients suffering from devastating diseases. With a robust pipeline and a commitment to scientific advancement, PureTech is at the forefront of biotherapeutic development, aiming to bring transformative treatments to market.