Biora Therapeutics remains on track for IND filing for PGN-600

Biora Therapeutics announced feedback from the United States Food and Drug Administrationon its clinical development plans for its PGN-600 program, and provided program updates. For Biora’s Targeted Therapeutics Platform, which is focused on treatment of ulcerative colitis, the company remains on track for an IND filing for its PGN-600 program followed by clinical trial initiation. During Q4 2022, Biora continued its engagement with the FDA with a pre-IND supplemental Type C filing requesting agency feedback on its proposed PGN-600 clinical development plans, including the company’s proposed approach to toxicity studies and other aspects of its clinical plan. "The recent Type C response from the FDA further strengthens our confidence in our plans to enter the clinic during the first half of 2023 with IND filing followed by trial initiation in Q2, and data readouts anticipated in Q3," said Adi Mohanty, Chief Executive Officer of Biora Therapeutics. "Based on previous studies, we know that achieving the appropriate concentration of tofacitinib in the tissue of the large intestine is correlated with endoscopic improvement, and we believe that reducing systemic exposure to tofacitinib could be a paradigm shift in the ability to help a substantial percentage of patients. Our planned clinical trial should provide insights on these very important tissue and plasma levels, along with the safety of our approach. With this critical data anticipated during the phase 1 trial, we look forward to progressing a program that could have significant impact on patient care for ulcerative colitis." For Biora’s Systemic Therapeutics program, the company has been transitioning from early concept to a clinical-ready device. With several of the key device upgrades implemented, the company expects to report data from preclinical studies on its next-generation device during Q1 and Q2 of 2023.