FDA Grants Fast Track Designation to Pliant Therapeutics for PLN-74809 for Treatment of Primary Sclerosing Cholangitis

The U.S. Food and Drug Administration granted Fast Track designation to Pliant Therapeutics’ PLN-74809, an oral, dual-selective αvß6 / αvß1 integrin inhibitor, for the potential treatment of primary sclerosing cholangitis.

Photo: Éric Lefebvre, chief medical officer at Pliant Therapeutics

Primary sclerosing cholangitis (PSC) is a rare, progressive liver disease of unknown origin, which frequently occurs in the setting of inflammatory bowel disease. PSC affects more than 30,000 patients in the United States and over 100,000 patients worldwide. The disease can occur in all ages, gender, and race. PSC is characterized by inflammation and fibrosis, with progressive liver and biliary damage leading to cirrhosis and its complications. Currently there are no FDA or EMA-approved therapies for patients with PSC. Therefore, there is a high unmet need for new therapeutic options to address the symptoms and modify the disease progression of this grievous illness.

The company’s lead drug candidate, PLN-74809 is currently being tested as part of the INTEGRIS-PSC phase 2a clinical trial. Pliant anticipates topline data from this randomized, double-blind, placebo-controlled trial in patients with PSC, in the first half of 2023.

“Fast Track designation in primary sclerosing cholangitis represents a significant milestone in PLN-74809’s development,” said Éric Lefebvre, chief medical officer at Pliant Therapeutics. “PSC is a deadly disease with no FDA-approved therapies. Fast Track designation underscores the urgent need for new therapeutic options to address PSC and other fibrotic diseases.”

FDA’s Fast Track designation is intended to facilitate and expedite the development and review of new drugs to treat serious or life-threatening conditions. To qualify, available clinical and nonclinical data need to demonstrate the potential to address unmet medical need. The benefits of Fast Track designation include opportunities for frequent meetings with the FDA to discuss trial design, development plans and data needed to support drug approval, as well as the ability to submit a New Drug Application (NDA) on a rolling basis, and eligibility for priority review, if relevant criteria are met.

Author: Rare Daily Staff