Pliant’s IPF Experimental Therapy PLN-74809 Renamed Bexotegrast
24-week follow-up and 12-week interim trial data expected early next year
The change came after the International Nonproprietary Names Expert Group selected bexotegrast as the unique generic, or nonproprietary, name for the experimental therapy.
The company also announced 24-week follow-up data and 12-week interim data from the high-dose group of PLN-74809 in the Phase 2a INTEGRIS-IPF clinical trial (NCT04396756) are expected early next year.
“Several near-term clinical data readouts, including the 12-week and 24-week data from the INTEGRIS-IPF program [are expected] in early 2023 and the first half of 2023,” Bernard Coulie, MD, PhD, president and CEO of Pliant Therapeutics, said in a press release.
PLN-74809 is a small molecule that blocks the activity of two proteins belonging to the integrins family: alpha v beta 6 and alpha v beta 1. Integrins are cell surface proteins that play a key role in cell adhesion and communication. They also are thought to be involved in tissue scarring, or fibrosis. By blocking these integrins, PLN-74809 is expected to help prevent the development and expansion of fibrotic tissue in the lungs.
INTEGRIS-IPF is testing the safety, tolerability, and pharmacokinetics of PLN-74809 versus a placebo in IPF patients, ages 40 and older. Most participants received standard-of-care IPF treatments, such as Esbriet (pirfenidone) or Ofev (nintedanib). Pharmacokinetics studies how a medication moves into, through, and out of the body.
Participants were originally assigned to receive one of three possible doses of PLN-74809 (40, 80, or 160 mg), taken daily for 12 weeks.
According to top-line data previously announced, PLN-74809 was well-tolerated when given up to a dose of 160 mg. The therapy also slowed lung function decline when given with or without current IPF standard-of-care therapies.
Lung function was assessed using forced vital capacity, a lung function parameter that measures how much air a person can forcibly exhale after a deep breath, and the Quantitative Lung Fibrosis score, which assesses the extent of lung fibrosis based on imaging tests.
Treatment with a higher dose of 320 mg is also underway. The therapy is being administered over at least six months and up to 48 weeks to approximately 28 patients.
Testing of the higher dose followed a positive a safety review conducted by the study’s data safety monitoring board (DSMB) — an independent group of specialists who monitor patient safety and treatment effectiveness during a trial — of all doses tested.
The DSMB concluded the trial and the last dosing regimen of 320 mg could proceed without any modifications.
“The positive DSMB safety review of the ongoing INTEGRIS-IPF trial … added to the growing favorable safety profile of this novel drug candidate,” Coulie said.