Ampio Pharmaceuticals (NYSEMKT:AMPE) issues a press release stating that the data analysis from its just-completed Phase 3 STEP trial (STEP) evaluating single injection Ampion (human serum albumin) versus placebo as a treatment for osteoarthritis of the knee may be delayed due to the discovery that the study drug may have been exposed to lower temperatures during shipping than permitted by its specifications despite the fact that the products were packaged correctly and shipped by a specialized drug shipment vendor. Since exposure to low temps has the potential to compromise the potency of Ampion, the firm questions whether it should use the data in its BLA submission. The company has apparently contacted the FDA for guidance on the issue.
Coincidentally, Ampio just happens to have a solution to the problem. It has 6-week interim data from its ongoing Phase 3 trial evaluating three injections of Ampion for osteoarthritis of the knee. Patients improved 86% on pain score and 87% on function score. Its August 18 press release refers to the data as "very positive" results.
The company says that it is meeting with its regulatory advisors about the feasibility of substituting the multi-injection data for the singe-injection data in its BLA submission.
AMPE share are down 19% premarket on robust volume.