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Biotherapeutics company PureTech Health said results from a study showed that approximately 50% fewer subjects treated with its LYT-100 drug experienced gastrointestinal-related adverse events compared to subjects treated with pirfenidone.
Pirfenidone is approved by the U.S. Food and Drug Administration for the treatment of idiopathic pulmonary fibrosis, an orphan disease that is 'chronic and progressive resulting in significant morbidity and mortality,' the company said.
Based on these results, the company said it intends to advance LYT-100 into late-stage clinical development for the treatment of idiopathic pulmonary fibrosis, beginning with a dose-ranging study evaluating six months of treatment with LYT-100 initiating in the first half of 2022.
'PureTech believes the results of this study, together with a Phase 3 study, could serve as the basis for registration in the U.S,' it added.