Evidence for Delay of Total Knee Replacement (TKR) for Patients with Severe Osteoarthritis of the Knee Receiving Three Intra-articular (IA) Ampion™ Injections

ENGLEWOOD, Colo., March 26, 2018

The STRUT study (AP-007, ClinicalTrials.gov NCT02184156) was a randomized, saline vehicle-controlled study to evaluate the safety and efficacy of Ampion™ when administered as three 4mL IA injections delivered every two weeks (at Baseline, Week 2, and Week 4). The trial was conducted in two phases at a US clinic: 1) a 7-patient single-blind phase where all patients received Ampion™; 2) a 40-patient double-blind phase where patients were randomized 1:1 to Ampion™ or saline. The primary endpoint was change in WOMAC A pain between baseline and week 20.

Dr. David Bar-Or, MD, Ampio's CSO, explained, "An IRB approved protocol was followed to survey the TKR status of the STRUT study patients approximately 3.5 years after treatment with Ampion™ or saline vehicle control. All subjects were contacted by the clinical site which recruited and enrolled these subjects. In total, 39 of 45 patients (87%) responded to the telephone questionnaire interview. An initial analysis of the results revealed:  

• The severe KL4 patients most likely to require a TKR (n=16), treated with Ampion obtained a lower rate of TKR compared to patients treated with saline (40.0% or 4/10 vs. 83.3% or 5/6).
• The KL4 subset of patients that were responders (n=10) treated with Ampion also obtained a lower rate of TKR compared to patients treated with saline (14.3% or 1/7 vs. 100% or 3/3), a result which did reach significance (p=0.033).

A more detailed analysis of this follow up study will be presented in a peer-reviewed publication."

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 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™, as well as those associated with clinical trials, regulatory approvals, the ability of Ampio to enter into partnering arrangements, the Biological License Application (BLA) 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.