The forty patient randomized (1:1) phase of the STRUT study was conducted to assure that multiple injections of Ampion™ were safe and effective. Each patient received three 4 mL intra-articular injections of Ampion™ or saline at baseline, 2 weeks and 4 weeks. There were no drug related serious adverse events reported during the 20 weeks of this trial; the top-line results are as follows:
- WOMAC A: The primary endpoint that is required for FDA approval, WOMAC A pain score, improved by 64% from baseline to 20 weeks. Ampion™ improved by -1.41 (0.81) compared to saline vehicle control which improved by -0.85 (0.64), p=0.0231.
- Responder Rate: Responder rate is defined as a change of at least 1 point in the WOMAC A pain subscale. Responder rate for Ampion™ was 79% compared to 47% of saline patients, p=0.0451.
Detailed results of the STRUT study will be published in peer reviewed journals and presented at scientific conferences.
Data for the larger, multi-site STRIDE study (similar design to STRUT study) is expected in second quarter 2015.
About Ampio Pharmaceuticals:
Ampio Pharmaceuticals, Inc. is a clinical trial 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 completion, timing and size of the registered direct offering, as well as risks associated with clinical trials, expected results, regulatory approvals, and changes in business conditions and similar events. 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.
Ampio Pharmaceuticals, Inc.
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