Ampio Pharmaceuticals, Inc
) declined significantly after the company announced that there
will be a delay in the data analysis of the STEP Study on its
The study has been delayed as certain specifications were not
fulfilled. The independent Clinical Research Organization (CRO)
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
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. (
), Mallinckrodt plc (
) and AstraZeneca plc (
). While Allergan and Mallinckrodt sport a Zacks Rank #1 (Strong
Buy), AstraZeneca holds a Zacks Rank #2 (Buy).
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