AMPE - Ampio cleared to complete Phase 3 study for osteoarthritis

Ampio Pharmaceuticals (AMPE) says it has received guidance from the FDA regarding the impact of COVID-19 on its Phase III clinical trial for osteoarthritis of the knee ("OAK").Conducted under a Special Protocol Assessment, the late-stage trial involved the intra-articular injection of Ampion for treatment of severe OAK, potentially leading to a commercial Biologics Licensing Application to the FDA.According to the company, the FDA has agreed that the OAK is a highly prevalent condition that affects millions of patients in the U.S., and the guidance enables it to complete the study without re-running the trial.Thanking the flexibility offered, the company says it is looking forward to a solution that will allow it to proceed despite COVID-19 as it expects to submit the analysis and proposal to the FDA as soon as possible.Amid the rising number of COVID-19 cases, the patient enrollment of the study was suspended in March to minimize the risk to trial

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Ampio cleared to complete Phase 3 study for osteoarthritis