Talphera, Inc. (Nasdaq: TLPH) announced that the FDA has agreed to review a Prior Approval Supplement (PAS) to reduce the number of patients required for the NEPHRO CRRT clinical study evaluating Niyad. This decision follows a meeting between Talphera and the FDA, marking a significant step toward streamlining the trial process. The company anticipates submitting the PAS within the coming week.
Protocol Amendments to Enhance Enrollment
In addition to the PAS agreement, the FDA approved two protocol changes aimed at broadening the inclusion criteria for the NEPHRO CRRT study. These changes will now permit the enrollment of patients already undergoing continuous renal replacement therapy (CRRT) for more than 48 hours, as well as heparin-tolerant patients at select institutions. These modifications are being implemented through a five-day protocol amendment notice, which does not require additional FDA review.
Impact on Study Timeline
Shakil Aslam, MD, Talphera's Chief Medical Officer, stated, "We continue to evaluate and focus on opportunities to support completion of the NEPHRO CRRT study by the end of the year." Dr. Aslam emphasized that the agreement to submit a PAS, along with the broadened inclusion criteria, is expected to accelerate enrollment. He also noted that Talphera's breakthrough designation status and collaboration with the FDA reinforce their confidence in nafamostat as an alternative anticoagulant for patients on CRRT.
About Niyad and the NEPHRO CRRT Study
Niyad, Talphera's lead product candidate, is a lyophilized formulation of nafamostat, a broad-spectrum serine protease inhibitor with anticoagulant, anti-inflammatory, and potential anti-viral properties. The NEPHRO CRRT study is a prospective, double-blinded trial conducted across up to 14 U.S. hospital intensive care units. It aims to enroll 166 adult patients undergoing renal replacement therapy who cannot tolerate heparin or are at risk of bleeding. The primary endpoint is the mean post-filter activated clotting time using Niyad versus placebo over the first 24 hours. Secondary endpoints include filter lifespan, number of filter changes, number of transfusions, and dialysis efficacy.
