A new clinical trial testing the idiopathic pulmonary fibrosis (IPF) drug candidate LYT-100 (deupirfenidone) has been initiated.
“The initiation of this study is supported by substantial clinical data demonstrating favorable safety and tolerability of LYT-100,” Julie Krop, MD, chief medical officer of PureTech, the developers of LYT-100, said in a press release. “We are excited to be taking this important step towards our goal of helping patients with this devastating condition.”
The clinical trial is a global, randomized, placebo-controlled registration-enabling study designed to test the safety, tolerability, efficacy, and dosing regimen of LYT-100.
Around 240 patients with IPF will either receive 550 mg of LYT-100 3 times a day, 825 mg of LYT-100 3 times a day, pirfenidone at the dose approved by the US Food and Drug Administration (FDA), or a placebo.
Pirfenidone is already approved by the FDA to treat IPF. However, it can cause severe gastrointestinal side effects that can lead to the discontinuation or a dose reduction of the treatment.
Read more about pirfenidone
LYT-100 is a selectively deuterated form of pirfenidone that retains the same antifibrotic and anti-inflammatory activity. It has already been tested in more than 400 patients and showed a favorable safety and tolerability profile.
The doses used during the trial correspond to exposure as the currently approved dose of pirfenidone and a higher exposure than the currently approved dose of pirfenidone, which has a potential for improved efficacy. The primary outcome measure of the trial will be the difference in the slope of decline in forced vital capacity over 6 months
The results of the trial will help in the design of a potential pivotal study to assess the relative efficacy of LYT-100 compared to pirfenidone. Topline results are expected by the end of 2023.
PureTech initiates late-stage clinical study of wholly-owned candidate LYT-100 (deupirfenidone) in IPF and advances LYT-200 (anti-galectin-9 mAb). News release. PureTech; June 30, 2022.