ENGLEWOOD, Colo., November 10, 2016 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) updates its continuing discussions with the CBER Division of the FDA seeking the best path forward to obtain a Biological License for Ampion™ to treat patients suffering from pain caused by severe Osteoarthritis of the knee (OAK) and preliminary results from AP-011, its “hand” trial of Ampion™.
Michael Macaluso, Ampio’s CEO, noted “We are grateful to the FDA for the number of fair and reasonable paths forward to a Biological License for Ampion™ they have provided to Ampio. We hope to have a final decision on the path we will follow by year-end. As soon as we have further information, we will report the same to our shareholders.”
Mr. Macaluso next announced the completion of AP-011, a Study to Evaluate the Safety of a Single Intra-articular Injection of Ampion™ for Arthritis of the Basal Thumb Joint.
Macaluso noted “The AP-011 hand trial was 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. Safety was examined by reported adverse events (AEs) during the study period and reduction of pain was assessed with the AUSCAN A index (5 questions related to pain and validated for OA of the hand). This limited clinical trial focused on safety and was not powered to statistically evaluate efficacy”.
The results were:
- Fifteen (15) patients enrolled: 9 in the Ampion™ arm and 6 in the saline arm.
- Ampion™ intra-articular injection into the basal thumb joint was well tolerated. Three (3) AEs were reported, all of mild severity (2 AEs with Saline-1 unrelated and 1 possibly related and 1 AE with Ampion™-unrelated)).
- At week 4, improvements in pain following treatment with Ampion™ were reported at week four compared to baseline. 66.7% of patients treated with Ampion™ had an improvement in pain on the AUSCAN A index. Conversely, in the saline group, 33% improved one did not change and three deteriorated.
- Greater improvement in pain reduction from Ampion™ appeared to occur when the severity of OA was greater.
Mr. Macaluso continued “These preliminary results were not unexpected as they are consistent with the results from over 1800 patients in our OA of the knee studies. Our next “hand” trial may examine more frequent dosing and treat the entire area of the hand and not just a single joint. We will wait for a final decision from the FDA on the status of our OA of the knee trials before addressing our next steps for getting Ampion™ approved for treating OA of the hand. The FDA decision will impact all future Ampion™ trials and the way we conduct them.”
Osteoarthritis (OA) is a progressive disorder of the joints involving degradation of the intra-articular cartilage, joint lining, ligaments, and bone. The World Health Organization has determined that OA will be the fourth leading cause of disability worldwide by the year 2020. In the United States, the Center for Disease Control (CDC) reports that OA affects 13.9 % of U.S. adults aged 25 years and older and describes their estimate of 26.9 million U.S. adults afflicted in 2005 as conservative. The incidence of developing osteoarthritis of the knee over a lifetime is approximately 45%. As this disease is associated with aging, obesity, and diabetes this number will continue to grow. Certain risk factors in conjunction with natural wear and tear lead to the breakdown of cartilage. Osteoarthritis is caused by inflammation of the soft tissue and bony structures of the joint, which worsens over time and leads to progressive thinning of articular cartilage. Other symptoms include narrowing of the joint space, synovial membrane thickening, osteophyte formation and increased density of subchondral bone.
About Osteoarthritis (OA) of the basal thumb joint
OA of the basal thumb joint is predominantly seen in post-menopausal women and increases with age. The 2015 Global Data Epidemiology Forecast reports that OA in the hand is more prevalent than OA of the knee, projecting that total cases of hand OA in the seven major markets will rise from 151 million in 2014 to 176 million by 2024. Typical patients complain of pain localized to the base of the thumb exacerbated by activity. Osteoarthritis is caused by inflammation of the soft tissue and bony structures of the joint, which worsens over time and leads to progressive thinning of articular cartilage, narrowing of the joint space, synovial membrane thickening, osteophyte formation and increased density of subchondral bone. Daily activities such as grasping large objects, unscrewing jar tops, turning door knobs and writing can worsen symptoms and be quite debilitating. Non-steroidal anti-inflammatory drugs (NSAIDs) and intra-articular (IA) steroid injections are used when conservative methods are ineffective. However, NSAID’s have significant limitations due to adverse effects such as gastrointestinal (GI) irritation and bleeding. Repeated injections of steroids have a diminishing effect and can theoretically weaken the capsular support of the joint and compromise articular cartilage. Therefore, there is a need for additional anti-inflammatory drug treatments for OA, particularly as the population ages.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of therapies to treat prevalent inflammatory conditions for which there are limited treatment options. We are developing compounds that decrease inflammation by (i) inhibiting specific pro-inflammatory compounds by affecting specific pathways at the protein expression and at the transcription level; (ii) activating specific phosphatase or depletion of the available phosphate needed for the inflammation process, and (iii) decreasing vascular permeability.
Ampio’s statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as “believe,” “expect,” “plan,” “anticipate,” and similar expressions. These forward-looking statements include statements regarding Ampio’s expectations with respect to the Company’s discussions with the FDA, the Ampion™ AP-011 study, as well as risks associated with clinical trials, expected results, regulatory approvals, and decisions and changes in business conditions and similar events. These forward-looking statements also include statements regarding the Biological License Application (BLA). The risks and uncertainties involved include those detailed from time to time in Ampio’s filings with the Securities and Exchange Commission, including without limitation, under Ampio’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.
Gregory A. Gould
Chief Financial Officer
Phone: (720) 437-6500