PureTech Health presented clinical data supporting the differentiated profile of LYT-100 or deupirfenidone at the CHEST Annual Meeting in Honolulu, Hawaii. The presentation expands on data from a completed trial of LYT-100 in healthy older adults, which informed the two doses selected for the ongoing, global Phase 2b dose-ranging trial of LYT-100 ELEVATE IPF in patients with idiopathic pulmonary fibrosis, IPF . In addition to supporting the improved tolerability of LYT-100 versus the FDA-approved dose of pirfenidone, the data provide insights into the selection of the higher dose of LYT-100 that is also being evaluated in ELEVATE IPF. The trial showed that a 550 mg dose of LYT-100 given three times daily,TID, provided bioequivalent drug exposure to the FDA-approved dose of pirfenidone, 801 mg TID. LYT-100 also demonstrated a 24% lower peak drug concentration than pirfenidone, which is a key factor generally associated with tolerability. “Our goal with the ELEVATE IPF trial is to validate the ability of LYT-100 to deliver a more tolerable treatment with equivalent efficacy to pirfenidone at one dose while also exploring the potential for enhanced efficacy at a higher dose.” “Tolerability is a major challenge with the currently available IPF treatments, and it often results in both temporary and permanent dose reductions, premature discontinuation and a reluctance for patients to even begin treatment,” said Dr. Toby Maher, M.D., Ph.D., Professor of Medicine and Director of Interstitial Lung Disease at Keck School of Medicine, University of Southern California, Los Angeles, who is presenting the poster at CHEST and is an investigator in the ELEVATE IPF trial. ”
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