Ampio Pharmaceuticals' (NYSEMKT:AMPE) osteoarthritis (OA) of the knee drug, Ampion, has experts guardedly positive on the drug's chances for approval despite failure of one Phase III.
The ongoing inclusion of and prior success with Kellgren-Lawrence IV (KL4), the most severe knee OA patients, bodes well for the drug's approval if the ongoing Phase III PIVOT trial (NCT02556710) succeeds, experts agreed. This news service previously reported expert optimism for PIVOT, given positive data seen with the Phase III SPRING trial (NCT01839331) and PIVOT's similar design to SPRING.
The failure of the STRIDE Phase III study (NCT02242435) has experts cautious, though they noted STRIDE was designed differently, including having a 20-week time frame for primary endpoint measurement. Some experts noted a preference for a Phase III trial with a longer duration to prove the drug's durability, but all acknowledged the 12 weeks used in SPRING and PIVOT is standard protocol.
The FDA gave Ampio a Special Protocol Assessment (SPA) for PIVOT. Results are expected mid-2016, according to a 29 March press release.
Ampion is a low molecular weight fraction of human serum albumin (HSA).