Enrollment Complete for Phase 2 Trial Testing Anti-fibrotic PLN-74809
Enrollment has been completed for INTEGRIS-IPF, a Phase 2a trial testing PLN-74809, an experimental oral anti-fibrotic therapy, in people with idiopathic pulmonary fibrosis (IPF).
Pliant Therapeutics, the company developing PLN-74809 and sponsoring the trial, said it is expecting top-line results to become available midway through the year.
The company also announced that the U.S. Food and Drug Administration (FDA) has given the all-clear to conduct long-term dosing of PLN-74809 when given at doses up to 320 mg in individuals with IPF. The FDA authorization is expected to allow for larger, long-term pivotal trials.
“The completion of enrollment of INTEGRIS-IPF and the FDA authorization of long-term dosing of PLN-74809 in idiopathic pulmonary fibrosis reflect our team’s unwavering commitment to executing against our clinical development plan for PLN-74809,” Bernard Coulie, MD, PhD, president and CEO of Pliant, said in a press release.
This milestone, Coulie added, “illustrates another step in the ongoing de-risking of PLN-74809 in IPF and positions the program for later stage development.”
PLN-74809 is designed to block the activity of two integrins — alpha v beta 6 and alpha v beta 1 — which are proteins involved in cell-to-cell adhesion. These integrins, proteins found on cell surfaces, are thought to be involved in driving fibrosis, or tissue scarring, in IPF and other fibrotic diseases.
Previous Phase 1 studies conducted with healthy volunteers have suggested that the investigational therapy is generally well-tolerated. According to Pliant, more than 450 people have been dosed with PLN-74809 thus far, with no serious side effects reported to date.
Data from Phase 1 studies also suggested that the therapy candidate was able to prevent the activation of a profibrotic signaling molecule called TGF-beta in healthy volunteers. Further Phase 1 data is expected in the coming months.
The global INTEGRIS-IPF trial (NCT04396756) recruited 84 adults with IPF across 29 study locations. Participants are randomly assigned to receive PLN-74809 at doses of 40, 80, or 160 mg, or a placebo, for 12 weeks (about three months).
The study’s main goal is to assess the safety, tolerability, and pharmacological properties of the anti-fibrotic therapy. Measures of lung function and other efficacy assessments also will be evaluated as exploratory endpoints.
In addition to INTEGRIS-IPF, Pliant is planning to launch a six-month Phase 2a trial to test PLN-74809 when given at a dose of 320 mg. That trial, which also will involve IPF patients, is expected to start in the first half of this year.
The company also is conducting another Phase 2a trial, called INTEGRIS-PSC (NCT04480840), that is testing PLN-74809 in a disease called primary sclerosing cholangitis. The disorder, which affects the bile ducts, is often associated with liver scarring.
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