FDA grants fast track designation to CNP-104 for treatment of primary biliary cholangitis
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Biotechnology company COUR Pharmaceuticals announced that the FDA granted fast track designation to CNP-104, an investigational therapy for the treatment of primary biliary cholangitis, according to a company press release.
“The fast track process is designed to facilitate development for patients with current limited options,” John Puisis, COUR CEO, told Healio. “This designation facilitates early and frequent communication between the FDA and COUR to quickly resolve any questions or issues and can lead to earlier drug approvals and faster access for patients.
“Fast track designation, when used effectively, can accelerate the approval process of a new therapy through eligibility for both accelerated approval, priority review as well as rolling review processes. Utilizing these pathways, COUR endeavors to bring CNP-104 to market as soon as possible,” Puisis, said.
According to the release, CNP-104 uses COUR’s proprietary nanoparticle platform, which combines disease-specific antigens with immune-modifying nanoparticles to treat immune disorders such as primary biliary cholangitis (PBC). The novel therapy was developed in collaboration with Ironwood Pharmaceuticals Inc.
COUR plans to conduct a phase 2, proof of concept study for CNP-104 in early 2022 to assess the safety, tolerability, pharmacodynamics and efficacy of the therapy in patients with PBC.
“The phase 2 PBC trial is designed to show that CNP-104 can stop progression of PBC disease with improved liver function,” Puisis said. “If successful in phase 2, COUR would seek breakthrough therapy designation for CNP-104 and focus on meeting agreed upon endpoints for pivot trials suitable for a [biologics license application] filing.”
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