Ampio Pharmaceuticals Inc (NYSE:AMPE) announced data from the modified Intent-to-Treat (mITT) population in the AP-013 Phase 3 trial of Ampion in severe osteoarthritis of the knee (OAK).
- The AP-013 study was designed to confirm the efficacy observed in the first pivotal trial, AP-003-A, and was powered to detect treatment differences between Ampion and saline control.
- In the mITT population (n = 618), which retained more than 85% power to evaluate improvements in pain, Ampion demonstrated a statistically significant reduction in pain and trended favorably toward improvement in function versus saline control.
- Further, the results in the Per Protocol efficacy population (n = 580), included in the original AP-013 statistical analysis plan, support these observations with a statistically significant reduction in pain and a statistically significant improvement in function versus saline control.
- Also See: Ampio To Test Inhaled COVID-19 Treatment In India.
- Ampio submitted a Type C meeting request to the FDA earlier this year. The agency will provide written responses to questions as the next step.
- The Company is on track to provide clarity on AP-013 by the end of 1H 2022.
- Price Action: AMPE shares are up 8.31% at $0.54 during the premarket session on the last check Thursday.
