ENGLEWOOD, Colo., November 22, 2017/PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced that a manuscript entitled: “LMWF-5A for the Treatment of Severe Osteoarthritis of the Knee: Integrated Analysis of Safety and Efficacy” has been published as a feature article in Orthopedics, a peer-reviewed journal that offers clinically valuable research covering all aspects of orthopedics. https://doi.org/10.3928/01477447-20171114-05
The article describes the efficacy and safety of Ampion™ (LMWF-5A) in an integrated analysis of three single injection randomized controlled studies of severe osteoarthritis of the knee (Kellgren-Lawrence [KL] grade 4 disease). The integrated analysis included 417 patients, to our knowledge the largest report on this patient population, who have been identified by the FDA as having an unmet medical need.
The end points of these studies were changes in pain, function and patient global assessment from baseline and compared to a saline control. Another outcome was the percent responder rate, defined by OMERACT-OARSI response criteria, compared to saline over a 12-week study period.
Provisional benchmarks advocated by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) range from 10% to 30% for a meaningful response in the treatment of chronic pain. The article details that Ampion™ has exceeded these thresholds in all previously conducted single-injection clinical trials and is statistically significant compared with patients receiving saline (p=0.016).
The primary end-point for the current pivotal trial of patients with severe osteoarthritis of the knee is responder rate compared to baseline. Patient-level response to treatment, as defined by OMERACT-OARSI criteria, addresses clinically important improvements, not just statistically significant improvements in outcomes. The article highlights the responder rate for Ampion™ in all previously conducted single-injection clinical trials (64.25%) demonstrated a meaningful response and was significantly better than the saline control (p=0.006).
Osteoarthritis (OA) is a progressive disorder of the joints involving degradation of the intra-articular cartilage, joint lining, ligaments, and bone. The incidence of developing osteoarthritis of the knee over a lifetime is approximately 45%. As this disease is associated with age, 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 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 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 scientific publications on our Ampion™ product. 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.
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