UK clinical-stage biotech PureTech Health (Nasdaq: PRTC) has presented new clinical data supporting the differentiated profile of LYT-100 (deupirfenidone) at the CHEST Annual Meeting in Honolulu, Hawaii.
According to the company, 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 IIb 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 US Food and Drug Administration (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.
PureTech noted that the trial showed that a 550mg dose of LYT-100 given three times daily (TID) provided bioequivalent drug exposure to the FDA-approved dose of pirfenidone, 801mg TID. LYT-100 also demonstrated a 24% lower peak drug concentration than pirfenidone, which is a key factor generally associated with tolerability. As previously announced, this dose also achieved an around 50% reduction in participants experiencing gastro-intestinal (GI) and central nervous system (CNS)-related adverse events (AEs) compared to those taking pirfenidone.
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