ENGLEWOOD, Colo., March 6, 2019, /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today updates the regulatory status of Ampion™.
Food and Drug Administration (FDA) provided guidance that Ampio should complete an additional trial of Kellgren Lawrence Grade 4 (KL 4) osteoarthritis of the knee (OAK) patients with concurrent controls that would be carried out under a Special Protocol Assessment (SPA). Ampio presented the FDA with two different forms of concurrent controls the company was considering in trial design: a saline injection or a sham injection, both previously identified by the FDA as possible controls. FDA correspondence, received on March 5, 2019, allows the Company to use either sham or saline intra-articular injection as a concurrent control in a confirmatory clinical study design.
Michael Macaluso, Ampio’s CEO noted that, “Taken as a group, the total KL 4 patient population receiving Ampion within our single injection clinical trials provided statistically significant superior results compared to those patients receiving the saline injection control. Therefore, we feel confident with the choice of either control option. The company will quickly determine which control to include in our trial design and then update and resubmit our SPA. We will be ready to begin the confirmatory clinical trial as soon as the SPA is awarded.”
Osteoarthritis (OA) is an incurable and 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 a therapy to treat a prevalent inflammatory condition for which there are limited treatment options. We are developing a compound that decreases inflammation by inhibiting specific pro-inflammatory compounds.
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 Ampion™ and its classification, as well as those associated with regulatory approvals and other FDA decisions including the timing thereof, the Biological License Application (BLA), the ability of Ampio to enter into partnering arrangements, clinical trials and decisions and changes in business conditions and similar events, all of which are inherently subject to various risks and uncertainties. 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 other documents filed with the Securities and Exchange Commission. 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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Ampio Pharmaceuticals, Inc.