Ampio (AMPE) Starts Final Phase III Study on Knee Pain Drug

Ampio Pharmaceuticals, Inc. AMPE announced that it has initiated the second phase III study on Ampion for the treatment of pain and inflammation due to osteoarthritis of the knee. The company reached a Special Protocol Assessment SPA agreement with the FDA related to the study. Shares of Ampio gained almost 6% following the announcement.

We note that a SPA defines the study protocol including the endpoints required for approval of a candidate and significantly lowers the risks involved in the process and its commercialization.

This study is the final of two pivotal studies on Ampion, required by the FDA, to allow the company to submit a biologics license application for the candidate for the treatment of pain and inflammation due to knee osteoarthritis. The company said that the second phase III study on Ampion will be clinically identical to the first phase III Spring study on the candidate. Spring study met its primary endpoint and results were announced in 2013.

We note that Ampion is one of the late-stage candidates in the company's pipeline. Apart from Ampion, Ampio is working on developing Zertane, for the treatment of premature ejaculation. The company plans to initiate a phase III study on the candidate later this year. Being a development-stage company, Ampio largely depends on the successful development of its candidates for future growth.

Meanwhile, other companies are also working on developing new therapies for the treatment of osteoarthritis of the knee. Flexion Therapeutics FLXN is studying FX006 as an intra-articular therapy for moderate-to-severe pain due to knee osteoarthritis. Earlier this month, the candidate received fast track designation from the FDA for this indication. Additionally, Cytori Therapeutics CYTX is evaluating ECCO-50 in a phase IIb study for the treatment of patients suffering from knee osteoarthritis.

Investors looking for well-ranked stocks may consider Corcept Therapeutics Inc. CORT, carrying a Zacks Rank #1 (Strong Buy). Flexion holds a Zacks Rank #2 (Buy).

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