LYT-100 is well tolerated when given twice a day over multiple ascending doses, according to the results of a phase 1 clinical trial. Moreover, no maximum tolerated dose was observed during the trial, and there was a dose-proportional pharmacokinetic profile and modest food effect.
PureTech, the manufacturer of the treatment, announced that these findings will be presented at the European Respiratory Society International Congress, which will take place virtually from September 5-8, 2021.
LYT-100 is currently being evaluated in healthy volunteers, people with respiratory complications related to coronavirus disease 2019 (COVID-19), and patients with upper limb secondary lymphedema related to breast cancer. The company is also planning to evaluate the treatment in patients with idiopathic pulmonary fibrosis (IPF).
“These data further support the favorable tolerability profile of LYT-100 and have helped inform both our ongoing Phase 2 trials as well as potential future trials in additional indications, including idiopathic pulmonary fibrosis,” Michael Chen, PhD, the head of innovation at PureTech, said in a press release.
Read more about IPF experimental therapies
LYT-100 is a deuterated form of pirfenidone, an approved anti-inflammatory and antifibrotic medication. Researchers think it may have a favorable tolerability profile and may overcome the gastrointestinal adverse events associated with pirfenidone. According to Dr. Chen, it could even become a frontline treatment for patients with interstitial lung disease.
The aims of the phase 1 study are to determine the pharmacokinetics and maximally tolerated dose of LYT-100, as well as to conduct a food effect study in healthy volunteers. This will then be followed by a randomized, double-blind, placebo-controlled, phase 2 study in patients with breast cancer-related upper limb secondary lymphedema.
According to researchers at PureTech, their findings support further clinical development of LYT-100 in target populations given the adverse effect profiles of current antifibrotics.
PureTech presents phase 1 data for LYT-100 at the European Respiratory Society International Congress 2021. News release. PureTech; August 23, 2021.
LYT-100 in healthy volunteers and BCRL. ClinicalTrials.gov. January 28, 2020. Updated April 6, 2021. Accessed August 25, 2021.