Pliant Therapeutics has reported positive findings from the Phase IIa INTEGRIS-IPF clinical trial of the new investigational therapy, PLN-74809, to treat idiopathic pulmonary fibrosis (IPF) patients.
The multinational, double-blind, randomised, placebo-controlled trial analysed 40mg, 80mg and 160mg once-a-day doses of PLN-74809 versus placebo for 12 weeks.
It enrolled a total of 90 subjects with 67 in the active arms and 23 patients in the placebo arm.
Nearly 80% of trial subjects enrolled received standard of care and were split equally between nintedanib and pirfenidone.
Assessing the safety and tolerability of PLN-74809 was the trial’s primary endpoint while evaluation of pharmacokinetics was the secondary endpoint.
According to the findings, the trial met the primary and secondary endpoints.
PLN-74809 was found to be well tolerated at all three tested dose levels without any deaths or drug-associated serious adverse events (SAE) observed.
Furthermore, the therapy showed dose-proportional rises in plasma concentrations, in line with previous trials.
The trial’s exploratory endpoints assessed variations in forced vital capacity (FVC), high-resolution CT (HRCT)-based quantitative lung fibrosis (QLF) and serum biomarkers over 12 weeks of treatment.
Dose-proportional treatment effects on FVC and QLF compared to placebo were reported over 12 weeks.
Subject enrolment in the 320mg cohort of the trial concluded recently with 12-week interim data from this cohort anticipated earlier next year.
The company plans to submit the latest data to regulatory authorities soon to hold talks on the late-stage development of PLN-74809.
Pliant Therapeutics chief medical offer Éric Lefebvre said: “Data from the INTEGRIS-IPF trial exceeded our expectations exhibiting a favourable safety and tolerability profile and a treatment effect on FVC, the current registrational endpoint in IPF.
“Additionally, the dose-dependent reduction observed in the proportion of patients experiencing a decline in percent predicted FVC of ≥10% underscores the potential of this novel investigational therapy to advance the treatment of IPF.”
A chronic and progressive fibrosing lung disease of unknown cause, IPF has a reduced prognosis and less treatment options.