Friday, November 18, 2016

Ampio Pharmaceuticals, Inc. (AMPE) Targeting Common Inflammatory Conditions with Two Late-Stage Product Candidates

Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) is a development stage biopharmaceutical company focused on the discovery and development of novel therapies aimed at treating common inflammatory conditions for which there are limited treatment options. The company’s development pipeline currently features two product candidates advancing through late-stage clinical trials in the United States, including Ampion™ for the treatment of osteoarthritis of the knee (OAK) and Optina™ for the treatment of diabetic macular edema (DME).

Osteoarthritis, the most common form of arthritis, currently affects more than 100 million people in the United States alone, with over 48 million suffering from OAK. Meanwhile, the prevalence of DME is estimated at about 30 percent of patients inflicted by type I or type II diabetes mellitus for 20 years or more. For reference, roughly 11.3 percent of the U.S. population over the age of 20 lives with some form of diabetes.

Late last week, Ampio issued a news release updating its shareholders on the status its clinical development programs. The company is in ongoing discussions with the FDA’s Center for Biologics Evaluation and Research regarding the best path forward to obtain a Biological License for Ampion™ for the treatment of OAK. According to Michael Macaluso, chief executive officer of Ampio, the FDA has provided a “number of fair and reasonable paths forward to a Biological License” and Ampio hopes to “have a final decision on the path we will follow by year-end.”

In addition to its late-stage Ampion™ development program for the treatment of OAK, Ampio also recently completed a pilot study designed to examine the safety and efficacy of the candidate as a treatment for patients with osteoarthritis of the hand (OAH). Macaluso described the trial as “a small pilot study designed to examine the safety of a single injection of Ampion™ into the basal thumb joint of patients with hand OA, which is common, troublesome, and has limited treatment options.” After four weeks, 66.7 percent of patients treated with Ampion™ demonstrated an improvement in pain, while just 33 percent of patients in the control group noticed an improvement.

“These preliminary results were not unexpected as they are consistent with the results from over 1800 patients in our OA of the knee studies,” Macaluso added in a news release.

The most recent update regarding the development program for Optina™, issued early last month, notes that a manuscript, titled ‘Potential Beneficial Effect of Low Dose Danazol in Combination With Renin Angiotensin Inhibitors in Diabetic Macular Edema’, was accepted for publication in Acta Ophthalmologica, an international peer-reviewed journal in the field of ophthalmology. The article reports on the clinical benefits of Optina™, as observed from a 12-week multi-center, placebo-controlled, double-masked randomized trial. The findings were also presented at the 2016 annual meeting of the Retina Society in San Diego, California.

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