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): February 17, 2015
CELSUS THERAPEUTICS PLC
(Exact Name of Registrant as Specified in its Charter)
| England and Wales | 001-36288 | 98-1034922 | ||
|
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
53 Davies Street
London WIK 5JH
United Kingdom
(Address of Principal Executive Offices and Zip Code)
Registrant’s telephone number, including area code: +44-203-318-3004
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:
| ¨ | 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)) |
| Item 8.01. | Other Events. |
On February 17, 2015, Celsus Therapeutics PLC (the “Company”) announced that its Phase II clinical trial of MRX-6 Cream 2% in Pediatric Atopic Dermatitis did not reach its primary endpoint. A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits. |
| Exhibit Number |
Description | |
| 99.1 | Press Release dated February 17, 2015. |
SIGNATURES
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.
| CELSUS THERAPEUTICS PLC | |||
| Dated: February 17, 2015 | By: |
/s/ Gur Roshwalb | |
| Name: | Gur Roshwalb | ||
| Title: | Chief Executive Officer | ||
Exhibit 99.1
Celsus Therapeutics Announces That the Phase II Trial of MRX-6 Cream 2% in Pediatric Atopic Dermatitis Did Not Reach Primary Endpoint
MRX-6 Cream Did Not Demonstrate Separation from Vehicle in Primary Endpoint of Percent Improvement in the Investigator’s Global Assessment
NEW YORK and LONDON, February 17, 2015 (GLOBE NEWSWIRE) -- Celsus Therapeutics (NASDAQ: CLTX), an emerging growth, development-stage biopharmaceutical company, announced today the results from C012013, a Phase II, double-blind, parallel-group, vehicle-controlled study to evaluate the safety and efficacy of MRX-6 cream 2% in a pediatric population with mild to moderate atopic dermatitis. MRX-6 cream did not demonstrate a difference in mean change from baseline to Day 28 in the Investigator’s Global Assessment (IGA):
| Day 28 Topline results – ITT | |||
| MRX-6 Cream 2% (n=37) | Vehicle (n=35) | P value | |
| Mean Baseline IGA (SD) | 2.84 (0.37) | 2.71 (0.46) | 0.934 |
| Mean IGA Change from Baseline (SD) | -0.8 (0.92) | -0.8 (0.72) | 0.729 |
| Mean IGA % Change from Baseline (SD | -27.9% (31.44%) | -29.4% (28.61) | 0.920 |
| IGA Clear or Almost Clear (0 or 1) N (%) | 12 (32.4%) | 10 (28.6%) | 0.801 |
The trial enrolled 73 children with mild to moderate atopic dermatitis into a four-week double-blind period, followed by a four-week open label extension for those patients who wished to continue in the trial. Patients were randomized 1:1 in active and control arms of the trial.
“We are disappointed in the results of the trial, where there was a lack of change in the IGA score from baseline compared to vehicle and surprised by the high placebo response,” said Dr. Gur Roshwalb, Chief Executive Officer of Celsus Therapeutics. “We will continue to analyze the data fully and determine plans for our next steps, and provide an update at a later time. I want to thank our entire Celsus clinical team and the clinical investigators for their efforts in this trial. We also appreciate the patients and their families that were involved in this trial.”
About Celsus Therapeutics Plc
Celsus Therapeutics is an emerging clinical stage company focused on the development of a new class of non-steroidal, synthetic anti-inflammatory drugs termed Multi-Functional Anti-Inflammatory Drugs or MFAIDs. Celsus’s MFAIDs represent a potential new therapeutic platform for the treatment of a broad array of inflammatory diseases, such as inflammatory and autoimmune diseases. Presently, the Company’s lead drug candidate in its clinical pipeline is MRX-6, an MFAID topical cream treatment under development for treating skin inflammatory disorders, specifically atopic dermatitis, also known as eczema. Other potential treatments in preclinical development include OPX-1 for ocular inflammation, CFX-1 for cystic fibrosis, and OAX-1 for osteoarthritis.
FORWARD-LOOKING STATEMENTS – This press release contains “forward-looking statements” that involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms including “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would,” “hope,” “look forward” and similar expressions intended to identify forward-looking statements. Forward-looking statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including our ability to finance our operations, the future success of our scientific studies, our ability to successfully develop drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, and the enforcement of our intellectual property rights. Our most recent Annual Report on Form 10-K discusses some of the important risk factors that may affect our business, results of operations and financial condition. Unless we are required to do so under applicable laws, we do not intend to update or revise any forward-looking statements.
Investor Relations Contact
The Trout Group
Tricia Truehart
ttruehart@troutgroup.com
646-378-2953