Ampio Pharmaceuticals, Inc. announces initiation of a single injection study to meet the “unmet medical need” of treating the severe pain and loss of function associated with Kellgren-Lawrence (KL) grade 4 osteoarthritis of the knee (OAK) with a primary endpoint that follows the Osteoarthritis Research Society International (OARSI) guidance, utilizing the Outcome Measures in Rheumatology Clincal Trials (OMERACT) OMERACT-OARSI responder rate.
Dr. David Bar-Or, Ampio’s Chief Science Officer, clarified “In compliance with FDA guidance, this trial will be smaller than our prior trials with 171 patients, randomization of 6 to 1 (Ampion/Saline) on patients with severe OAK, defined radiologically as KL 4 patients. The 6-1 randomization will preserve blinding and prevent the bias in the assessment that might be associated with an unblinded evaluation; however, only Ampion treated patients will be evaluated. This 12-week study will evaluate the responder rate of Ampion treated patients as defined by OARSI, which includes pain, function, and patient global assessment (PGA). The outcome of this study will contribute to the label of Ampion which may include pain, function, and patient global assessment. Using the OMERACT-OARSI responder rate definition and the analysis proposed in this protocol, all previous Ampion single injections clinical trials would have successfully met this endpoint.”