FDA Places PLN-74809, IPF Therapy in Phase 2 Trial, on Fast Track
The U.S. Food and Drug Administration (FDA) has granted fast track designation to PLN-74809, now in a Phase 2 clinical trial, as a potential treatment for idiopathic pulmonary fibrosis (IPF).
This designation is intended to help speed the development of treatments aiming to address unmet medical needs for serious diseases. It allows PLN-74809’s developer, Pliant Therapeutics, to have more frequent meetings with the FDA to discuss the development process, and to submit an application seeking treatment approval on a rolling basis, rather than having to wait until the application is entirely finished to submit it.
“The Fast Track designation marks an important step in PLN-74809’s clinical development in IPF. It underscores the urgent need for new therapeutic options to address this devastating disease,” Éric Lefebvre, MD, Pliant’s chief medical officer, said in a press release.
PLN-74809 is designed to block the activity of certain cell surface proteins called integrins. Specifically, it inhibits alpha v beta 6 and alpha v beta 1, two integrins that are thought to help drive fibrosis, or tissue scarring, in IPF and other diseases.
Early data from Phase 1 studies in healthy volunteers indicated the experimental therapy is well-tolerated and capable of lowering the levels of fibrosis-driving signaling molecules.
Pliant is now sponsoring a Phase 2a clinical trial called INTEGRIS-IPF (NCT04396756) to test the safety, tolerability, and pharmacological properties of oral PLN-74809 in people with IPF.
The main study enrolled 84 adults with IPF, who were randomly assigned to a placebo or to PLN-74809 at doses of 40, 80, or 160 mg taken daily for about three months. Pliant recently announced an addition to the study testing a higher dose of 320 mg for at least six months in about 28 IPF patients.
This higher-dose extension may still be enrolling adults, ages 40 and older, at sites across the U.S., Australia, Canada, New Zealand, and Europe. Contact and site information is available here.
“We will continue to work closely with the FDA to support the future development of PLN-74809 beginning with data from the Phase 2a INTEGRIS-IPF trial, which is on track for readout [top-line results] in mid-2022,” Lefebvre said.
Pliant is also testing PLN-74809 in another Phase 2a trial, called INTEGRIS-PSC (NCT04480840), which is evaluating the therapy in people with primary sclerosing cholangitis, a disorder of the bile ducts that is commonly associated with scarring in the liver.
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