Healthy older adults given LYT-100, a deupirfenidone, reported fewer gastrointestinal (GI) adverse events than participants receiving pirfenidone (17.4% vs 34.0%), as published in a press release by PureTech Health. Pirfenidone is currently 1 of the 2 standard of care drugs for the treatment of idiopathic pulmonary fibrosis (IPF), however, it is associated with GI-related tolerability issues.
“In the recently completed healthy older adult study, LYT-100 administration resulted in a clinically meaningful 50% reduction in the number of healthy older adults experiencing GI-related adverse events, compared to pirfenidone,” Julie Krop, MD, chief medical officer of PureTech said.
“This underscores the potential of LYT-100 to address a significant unmet need for patients with IPF by offering a more tolerable treatment option that may allow patients to continue on therapy, which is critical to address this serious condition.”
Read more about IPF experimental therapies
The double-blind, randomized, crossover study investigated the tolerability of 550 mg of LYT-100 3 times a day with the recommended dose of 801 mg of pirfenidone 3 times a day. Previous experiments indicated that these doses result in similar exposure levels.
Participants receiving LYT-100 reported a lower amount of any adverse events than the pirfenidone cohort (30.4% vs 48.9%). There was a roughly 50% decrease in the most common side effect experienced in pirfenidone users, nausea, with only 15.2% of LYT-100 participants reporting this side effect compared to 29.8% in the pirfenidone group.
While these results show a decrease in adverse events, the study was not powered to show statistical significance. However, based on the encouraging results, PureTech plans to pursue a streamlined development program for LYT-100 utilizing the 505(b)(2) pathway, which allows for the submission of data not collected by the applicant to reduce unnecessary duplication of studies.
Along this pathway, the company plans to initiate a dose-ranging study in the first half of 2022 to compare the efficacy and tolerability of LYT-100 to pirfenidone in 250 treatment-naïve patients with IPF for 6 months.
In the currently reported study, a total of 49 healthy adults aged between 60 and 79 years were recruited, randomized, and received either LYT-100 or pirfenidone. This age group was selected as it is consistent with most patients with IPF.
PureTech’s LYT-100 (deupirfenidone) achieves 50% reduction in healthy older adults experiencing GI-related adverse events compared to pirfenidone. News Release. PureTech Health; January 6, 2022.