Ampio reports results from OA-201 studies do not support IND submission

Ampio announced the efficacy results from recently completed nonclinical pre-IND enabling studies with OA-201, Ampio’s only product development opportunity. Ampio reported that the efficacy results of these studies do not support an Investigational New Drug, or IND, submission which was anticipated in early 2025. Specifically, whereas previous smaller studies had demonstrated that OA-201 showed efficacy versus saline control to reduce pain and preserve cartilage in nonclinical models of osteoarthritis of the knee, the pain reduction benefit was not observed in the data from the recent set of preclinical studies which utilized a larger population of animal subjects. “We believe we need to demonstrate a statistically significant improvement in both pain reduction and cartilage protection to support the IND and justify the capital necessary to complete the planned Phase 1/2 trial. The data from the larger nonclinical pain reduction trial simply do not support the same pain reduction benefit as was demonstrated in the earlier, smaller, proof-of-concept trials,” said Michael Martino, Ampio’s Chief Executive Officer. The company’s management and the board are currently assessing both internal and external options. The company will be taking immediate actions to preserve its cash in order to be able to adequately fund any option identified by the board.