Ampio’s CRO completes Optina clinical trial for DME

Jun 11 2012

Ampio Pharmaceuticals, Inc. (Nasdaq: AMPE), a clinical stage biopharmaceutical company, whose lead drugs treat inflammatory diseases, including osteoarthritis and complications of Diabetes Mellitus such as diabetic macular edema (and others) announced today that it's CRO has completed analysis of the primary end point in the Optina™ clinical trial for DME conducted at St Michael Diabetes Hospital in Toronto Canada.

Dr. David Bar-Or, Ampio's Chief Science Officer (CSO), explained "The primary end point for efficacy was central subfield retinal thickness as measured by Optical Coherence Tomography (OCT) and reported in microns. The study was double masked and included 32 patients with moderate to severe diabetic macular edema (range 316-707microns) that were treated orally with either placebo or one of three doses of Optina™. Central retinal thickness and retinal volumes were measured at baseline and at 4 and 12 weeks of treatment. The results confirm a significant interaction between the patient's body mass index (BMI) and efficacy at the different doses of Optina™. For higher BMI (BMI=35) patients, higher doses of Optina™ were more effective and for lower BMI (BMI=26) patients, lower doses were more effective. The improvement of efficacy by adjusting the dose to the BMI is in agreement with both in vitro data as well as with the known strongly lipophilic nature of Optina™. At one of the low doses, regardless of BMI, there was a reduction of the subfield central retinal thickness of approximately 20% at 4 and at 12 weeks, which was statistically significant from placebo for the higher BMI group (p = 0.01).  The lowest dose of Optina™ showed a trend towards statistically significant reductions in central retinal thickness in the lowest BMI groups (p = 0.11 and p = 0.13) at 4 and 12 weeks, despite the small number of patients randomized to this dose.

Dr. Vaughan Clift, Ampio's Chief Regulatory Officer (CRO) further explained "These results are very important in the planning of our US trial as dose adjustments by body weight/BMI of Optina™ will be part of the trial design. Ampio has requested and received confirmation of a pre-IND meeting with the FDA on Optina™ for DME, which will take place in July 2012. That discussion will include complete analysis of the data including secondary end points."

Ampio's CEO, Michael Macaluso, noted "The company is meeting all of its clinical goals, right on schedule.  In addition to this confirmed July pre-IND meeting with the FDA for Optina™,

• On May 10, 2012, the company completed a pre-IND meeting with the FDA where agreement was reached on the design of a US pivotal clinical trial for Ampion™ to treat osteoarthritis in the knee.
• On June 20, 2012, the company will have a pre-IND meeting with the FDA to review its proposed design of a US pivotal clinical trial for Zertane™ to treat premature ejaculation (PE) in men.

Reaching these critical milestones to commercialization for our two most important anti-inflammatory drugs (Optina^TM and Ampion^TM) and our lead sexual dysfunction drug (Zertane^TM) in a three month time frame is a tribute not only to the quality of the drugs but to the hard work and competence of our clinical team"