AMPE Ampio Pharmaceuticals Inc

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of report (Date of earliest event reported): October 16, 2014

 

 

AMPIO PHARMACEUTICALS, INC.

(Exact name of registrant as specified in Charter)

 

 

 

Delaware		001-35182		26-0179592
(State or other jurisdiction of incorporation or organization)		(Commission File No.)		(IRS Employer Identification No.)

373 Inverness Parkway, Suite 200

Englewood, Colorado 80112

(Address of principal executive offices, including zip code)

(720) 437-6500

(Registrant’s telephone number, including area code)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

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Item 7.01 Regulation FD Disclosure

On October 16, 2014, Ampio Pharmaceuticals, Inc. (the “Company”) issued a press release announcing the results of the open label portion of the Multiple Intra-articular Injections Study of Ampion^TM in patients with osteoarthritis of the knee at week twelve of the trial. A copy of the press release is furnished hereto as Exhibit 99.1.

The information contained in this Item 7.01 and Exhibit 99.1 to this report shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, and shall not be incorporated by reference into any filings made by Ampio under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as may be expressly set forth by specific reference in such filing.

Item 8.01 Other Events

On October 16, 2014, the Company announced results of the open label portion of the Multiple Intra-articular Injections Study of Ampion^TM in patients with osteoarthritis of the knee at week twelve of the trial. The open label phase of the study consisted of seven patients and was performed to assure that multiple injections of Ampion^TM were safe. Each patient received three 4ml intra-articular injections of Ampion^TM, one at baseline, the second at two weeks and the third at four weeks. In addition, every patient received a high resolution MRI prior to the first injection and eight weeks after the last injection. There were no drug related serious adverse events reported during the first twelve weeks of this current trial.

Item 9.01 Financial Statements and Exhibits.

 

Exhibit Number		Description
99.1		Press Release dated October 16, 2014

This Current Report on Form 8-K and Exhibit 99.1 contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements typically are identified by use of terms such as “may,” “project,” “should,” “plan,” “expect,” “anticipate” “believe,” “estimate” and similar words, although some forward-looking statements are expressed differently. Forward-looking statements represent our management’s judgment regarding future events. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be correct. All statements other than statements of historical fact included in this Current Report on Form 8-K and in Exhibit 99.1 are forward-looking statements. Except as required by applicable law, the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. The Company cannot guarantee the accuracy of the forward-looking statements, and you should be aware that the Company’s actual results could differ materially from those contained in forward-looking statements due to a number of factors, including the statements under “Risk Factors” found in the Company’s Annual Reports on Form 10-K’s and its Quarterly Reports on Form 10-Q’s on file with the Securities and Exchange Commission.

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SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Dated: October 20, 2014

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EXHIBIT INDEX

 

Exhibit Number		Description
99.1		Press Release dated October 16, 2014

Exhibit 99.1

Ampio Announces Results of the Open Label Portion of the Multiple Intra-articular Injections (MI) Study of Ampion™ in Patients with Osteoarthritis of the Knee at Week Twelve of the Trial

Updates of the 47 patient and 320 patient MI studies

ENGLEWOOD, CO., October 16, 2014 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced updates for the STRUT and STRIDE multiple injection studies that are proceeding simultaneously.

Dr. Vaughan Clift, Ampio’s Chief Regulatory Officer explained “The seven (7) patient ‘open label’ phase of the 47 patient STRUT study was performed to assure that multiple injections of Ampion^TM were safe. Each patient received three 4ml intra-articular injections of Ampion™, one at baseline, the second at 2 weeks and the third at four weeks. In addition, every patient received a high resolution MRI prior to the first injection and eight weeks after the last injection. There were no drug related serious adverse events reported during the first 12 weeks of this current trial. The further results of this open label phase are as follows:

 

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WOMAC A: This primary endpoint pain score for the 7 patients improved by 95% from baseline at 12 weeks. (WOMAC A mean (SD) improved from 2.27(0.59) at baseline to 0.11(0.23) at week 12, mean difference (95% CI) -2.11(-2.71,-1.52), p=0.0001). In comparison, the WOMAC A pain score for the SPRING study improved by 42% at the same time point.

 

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WOMAC B: This secondary endpoint measurement of stiffness, also improved significantly by 89% from baseline at week 12 (from mean (SD) of 2.75(0.82) to 0.29(0.49), mean difference (95%CI) -2.43(-3.16,-1.70) p=0.0002). In comparison the WOMAC B score in the SPRING study showed no improvement over baseline at the same time point.

 

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WOMAC C: This secondary endpoint of a validated measure of simple daily physical functions improved by 92% from baseline at week 12 (WOMAC C mean (SD) improved from 2.37(0.55) to 0.19(0.23), mean difference (95% CI) -2.16(-2.83,-1.49), p=0.0002). In comparison, the WOMAC C score in the Spring Study improved by 22 % at the same time point.

 

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PATIENT’S GLOBAL ASSESSMENT of DISEASE Severity (PGA): As measured by the 5 point Likert score, this secondary endpoint improved significantly by 59% from baseline at week 12 (PGA from mean(SD) 3.50(0.84) to 1.43(0.53), mean difference(95%CI) -2.14(-3.27,-1.02) p=0.003 ). In comparison the PGA score in the Spring Study improved by 33% at the same time point.

“We have also completed enrollment and dosed the forty (40) additional patients of the randomized, placebo controlled phase of the STRUT study using the same multiple injections protocol and high resolution MRI analysis as the open label phase of the study. We will release these results as soon as they are available.”

Dr. Clift concluded “Ampio has also started the treatment phase of the randomized, placebo controlled, 320 patient STRIDE study that will follow the same multiple injection protocol as the STRUT study but will not include MRI analysis.”

“The results so far are encouraging”, noted Michael Macaluso, Ampio’s Chairman and CEO. “Baseline MRI’s and synovial fluid analysis for each patient performed just prior to the start of the injections, were repeated at week 12 and are currently being compared to baseline to explore whether there are additional clinical benefits beyond pain relief and improved function and stiffness. The MRI’s were submitted to an international Radiology expert whose expertise is in quantifying cartilage repair and the results will be announced when received by the company. Our manufacturing facility is now operational as demonstrated by the production of several thousand Ampion™ dose vials in preliminary engineering runs.”

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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.

Investor Contact:

April Ramirez

Operations Coordinator

Ampio Pharmaceuticals, Inc.

373 Inverness Parkway, Englewood, CO 80112

Direct: (720) 437-6524