Pliant Therapeutics has received a recommendation from the independent Data Safety Monitoring Board (DSMB) to progress the Phase IIa INTEGRIS-IPF clinical trial of PLN-74809 for idiopathic pulmonary fibrosis (IPF) without modification.
The double-blind, placebo-controlled, randomised trial is designed to evaluate PLN-74809 across various dosages given once a day.
At present, the subject cohort is analysing 320mg PLN-74809 given for a minimum of six months and up to 48 weeks, in nearly 28 IPF patients.
Following a meeting, the DSMB provided a positive safety review of the trial analysing 320mg once-a-day dose of PLN-74809 in IPF patients.
The review was carried out on concluding subject enrolment in the 320mg cohort of the trial and evaluated the safety findings from all subjects enrolled, with nearly 50% of them receiving treatment for a minimum of 12 weeks.
The company plans to report the interim 12-week findings from the 320mg dose cohort from the trial early next year.
Assessing the safety and tolerability of PLN-74809 is the primary endpoint of the trial, and evaluating pharmacokinetics is the secondary endpoint.
Evaluation of the variation in forced vital capacity (FVC), HRCT-based Quantitative Lung Fibrosis score (QLF), and selected biomarkers over six months of treatment are the trial’s exploratory endpoints.
In July this year, the company reported positive topline trial findings from the 40mg, 80mg, and 160mg 12-week dose cohorts.
An oral, small molecule, dual-selective αvβ6 and αvβ1 inhibitor, PLN-74809 is being developed to treat IPF and primary sclerosing cholangitis (PSC).
Pliant Therapeutics chief medical offer Éric Lefebvre said: “This positive safety review marks an important milestone in the development of PLN-74809.
“Given 320mg is the highest dose planned to be tested in the PLN-74809 programme, the positive DSMB review significantly builds on the favourable safety profile seen to date.
“In addition to the accumulating patient safety database, we have completed all necessary sub-chronic and chronic GLP toxicology studies of PLN-74809, with no on-target or off-target safety concerns noted to date across all doses tested.”