ENGLEWOOD, Colo., August 3, 2016 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) announced today that it has filed a meeting request and Briefing Document with the FDA to seek guidance on the filing of the company’s Biological License Application (BLA) for Ampion™ to treat patients suffering from pain caused by severe Osteoarthritis (OA) of the knee. The agency has discretion with regard to the type and scheduling of such a meeting, however, the company anticipates the meeting will take place in the 3rd quarter of this year.
In the second quarter of this year, Ampio submitted their Chemistry Manufacturing and Controls (CMC) documents for Ampion™ with the FDA, and requested the Agency provide any related guidance. The company recently received the Agency’s comments and believes there are no issues that will prevent the filing of an Ampion™ BLA.
Ampio also announced that the STRUT Study that treated pain due to OA of the knee with multiple injections of Ampion™, authored by Dr. John Schwappach, the trials Principal Investigator, was accepted for publication in the peer-reviewed journal “Orthopedics.” As soon as the journal is in print, we will post the article on Ampio’s website. The STRUT Study demonstrated a 64% reduction in pain compared to baseline.
Osteoarthritis is the most common form of arthritis, affecting over 27 million people in the United States. It 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 or hip over a lifetime is approximately 46% and 25%, respectively. 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 at the transcription level; (ii) activating specific phosphatase or depletion of the available phosphate needed for the inflammation process, and (iii) decreasing vascular permeability.
Forward Looking Statements
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 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 Ampion™ AP-003-B study, Ampio’s anticipated meeting with the FDA in the third quarter of this year, as well as risks associated with clinical trials, expected results, regulatory approvals, and changes in business conditions and similar events. These forward-looking statements also include statements regarding the Special Protocol Assessment (SPA) as well as the classification of Ampion™ as a novel biologic with 12 years exclusivity. 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