Amarin Reports Top-Line Results of two Phase III Studies of Miraxion in Huntington's Disease
Tuesday April 24, 8:59 am ET
Conference Call Begins Today at 11:00 a.m. Eastern Time
LONDON, April 24 /PRNewswire-FirstCall/ -- Amarin Corporation plc (NASDAQ: AMRN - News; "Amarin" or the "Company") today announces top-line results from its two Phase III clinical trials of Miraxion to treat Huntington's disease (HD). The Company conducted two Phase III double-blind, placebo-controlled studies in which HD patients were randomized to receive either placebo or 2 grams (1 gram twice daily) of Miraxion daily for six months. Study data showed no statistically significant difference in either study between Miraxion and placebo with regard to the primary and secondary endpoints.
These top-line findings are inconsistent with earlier clinical trial data that showed statistical significance in a subset of HD patients with a CAG repeat length of less than or equal to 44.
The primary endpoint of the trials was a change in the Total Motor Score 4 (TMS-4) component of the Unified Huntington's Disease Rating Scale (UHDRS). TMS-4 has been shown to be a sensitive measure of movement disorder in patients with HD. In addition, secondary endpoints included cognition and Total Functional Capacity outcomes. Miraxion was found to be safe and well-tolerated by patients.
Commenting on today's announcement, Rick Stewart, Chief Executive Officer of Amarin, said, "We are extremely surprised and disappointed by these top-line results, and we are analyzing the data in order to better understand the full and complete data set and outcomes. We are particularly disappointed that, at this time, we are not in a position to bring any positive news to those patients who are suffering from this devastating disease and to the broader HD community."
"Despite this setback with Miraxion to treat HD, we remain committed to developing Amarin's substantial central nervous system (CNS) development pipeline." commented Mr. Stewart. "We continue to evaluate the potential of Miraxion in treating CNS disorders and specifically our next steps with respect to the HD trials. We also intend to progress the development of our novel, oral formulation of apomorphine to treat the 'off' episodes in advanced Parkinson's disease patients, our recently in-licensed nasal formulation of lorazepam for the out-patient treatment of emergency seizures in epilepsy patients and our proprietary combinatorial lipid pre-clinical program in CNS disorders and other indications." concluded Mr Stewart.
Thomas Lynch, Amarin's Chairman, added "Our commitment to neurology research and product development remains steadfast and we will continue to pursue other in-licensing opportunities while we advance our broad pipeline of products to treat CNS disorders. Amarin has in place an experienced and committed management team and a strong financial position with approximately $29 million in cash at the end of March 2007."
The first study, TREND-HD, was conducted in 42 sites in the U.S. and Canada by the Huntington Study Group (HSG) based at the University of Rochester Medical School in Rochester, N.Y. This study, led by Principal Investigator Prof. Ira Shoulson, enrolled 316 patients with HD. The TREND-EU Phase III study was conducted in 27 sites in six countries across Europe and was conducted in conjunction with the European HD Network. This study was led by Principal Investigator Prof. Bernhard Landwehrmeyer, and enrolled 290 patients with HD.
These trials were developed under a Special Protocol Assessment (SPA) agreed with the U.S. Food and Drug Administration (FDA) and Miraxion for HD has Fast Track designation by the FDA and Orphan Drug designation in both the U.S. and in Europe.
Conference Call
Amarin management will host a conference call to discuss the clinical results from the two Phase III trials today beginning at 11:00 a.m. Eastern time. To participate in the call, please dial (800) 968-7995 from the U.S. or (706) 679-8403 from outside the U.S. A telephone replay will be available for a limited time following completion of the call by dialing (800) 642-1687 or (706) 645-9291, and entering reservation number 7199876. Participants can access the call over the Internet by visiting www.amarincorp.com where the call will be archived there for a limited period of time.
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