Shares of Ampio Pharmaceuticals, Inc. (AMPE) declined significantly after the company announced that there will be a delay in the data analysis of the STEP Study on its candidate Ampion.
The study has been delayed as certain specifications were not fulfilled. The independent Clinical Research Organization (CRO.V) found that Ampion and the placebo were exposed to lower temperatures than permitted as per specifications during shipment to clinical sites.
Ampion also discovered during a review of the documentation that there were multiple instances where the in-package temperature monitor fell significantly below the minimum required temperature.
We note that Ampio is developing Ampion for osteoarthritis of the knee. STEP is a randomized, placebo-controlled, double-blind study in which patients suffering from osteoarthritis knee pain were randomized to receive either a 4 mL single injection of Ampion or saline placebo control. The enrollment for the study was completed in Feb 2014.
The company was scheduled to release top line results from the study in the third quarter of 2014 and file the Biologic License Application (:BLA) by the first quarter of 2015.
Hence, the delay in the analysis from the study due to inappropriate drug specifications is quite disappointing. The delay will not only push back the BLA filing but also increase the costs involved in the study.
Meanwhile, Ampio is looking for alternative solutions to meet the requirements for the BLA filing for Ampion on schedule. Ampio is consulting regulatory advisors to substitute data from other studies (Multiple Injection study) for the filing. We note that Ampion is a key candidate for Ampio and expect investor focus on further updates from the study.
Ampio carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Allergan Inc. (AGN), Mallinckrodt plc (MNK) and AstraZeneca plc (AZN). While Allergan and Mallinckrodt sport a Zacks Rank #1 (Strong Buy), AstraZeneca holds a Zacks Rank #2 (Buy).