Corporate News Blog - Alkermes' Clinical Data on ALKS 8700 for MS, Demonstrates Safety and Gastrointestinal Tolerability
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LONDON, UK / ACCESSWIRE / October 31, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Alkermes PLC (NASDAQ: ALKS), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=ALKS. The Company shared on October 27, 2017, the clinical data from its ongoing open-label two-year phase-3 safety study EVOLVE-MS-1 for its drug candidate ALKS 8700. ALKS 8700 is a novel, oral monomethyl fumarate (MMF) prodrug candidate in development for the treatment of relapsing forms of multiple sclerosis (MS). For immediate access to our complimentary reports, including today's coverage, register for free now at:
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The interim clinical data from the EVOLVE-MS-1 which is being conducted on more than 570 patients who are being treated with one month and three months treatment using ALKS 8700 was presented by the Company at the MSParis2017. MSParis2017 is the 7th Joint Meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) held in Paris, France from October 25, 2017, to October 28, 2017.
Commenting on the data, Elliot Ehrich, M.D., Executive Vice President of Research and Development at Alkermes, said:
"We are encouraged by the safety data presented today for ALKS 8700, a MMF prodrug with distinct physical-chemical properties, as these interim results reinforce the safety and GI tolerability profile we set out to develop in a potential new oral therapy for the treatment of MS. We are committed to bringing this potential valuable new treatment to patients and providers and remain on track to announce initial data from the GI tolerability study comparing ALKS 8700 to TECFIDERA, and to submit the planned New Drug Application for ALKS 8700 in 2018."
Robert Naismith, M.D., Associate Professor of Neurology, Washington University School of Medicine in St. Louis, added:
"Fumarate therapy is recognized in the clinical community as an efficacious option for patients with MS, but it is also known to be associated with GI side effects that may lead to treatment interruption or discontinuation, particularly in the first few weeks following treatment initiation. A new treatment option that provides therapeutic levels of fumarate therapy with a differentiated safety profile would be a valuable and welcomed option for members of the MS community."
Safety and Gastrointestinal (GI) tolerability Data from EVOLVE-MS-1
The safety data from the first month of the EVOLVE-MS-1 study which was conducted on 580 patients treated with ALKS 8700 revealed that there were very low incidences i.e. 0.5% of GI adverse events (AEs) which lead to the discontinuation of the drug while not serious GI AEs were recorded. The most common adverse effect of ALKS 8700 treatment in the first month lead to flushing in 31.7% cases, pruritus in 7.4% cases, and diarrhea in 6.6% cases.
The safety data from the initial three-month EVOLVE-MS-1 study on 574 patients treated with ALKS 8700 revealed the support and extent of the safety profile of the drug. It was noted that 2.3% of patients reported serious GI AEs and nearly 3.7% patients experienced serious GI AEs which led to the patients discontinuing the treatment during the clinical study.
About EVOLVE-MS Clinical study
The name of study EVOLVE has been derived from Endeavoring to Advance Treatment for Patients Living with Multiple Sclerosis. The key components of the study for ALKS 8700 includes a two-year safety study and pharmacokinetic bridging studies comparing ALKS 8700 and TECFIDERA®. Biogen's TECFIDERA® (dimethyl fumarate) is a prescription medication used to treat people with relapsing forms of multiple sclerosis (MS). The clinical study also includes an elective head-to-head study comparing the GI tolerability of ALKS 8700 and TECFIDERA®.
About ALKS 8700
ALKS 8700 is Alkermes' oral, novel, and proprietary monomethyl fumarate (MMF) prodrug candidate which is being developed for the treatment of relapsing forms of multiple sclerosis (MS). ALKS 8700 is designed to rapidly and efficiently convert to MMF in the body and to offer differentiated features as compared to Biogen's TECFIDERA®.
What is Multiple Sclerosis?
Multiple sclerosis is an unpredictable, often disabling autoimmune disease that affects the central nervous system (CNS) which interrupts the flow of information within the brain, and between the brain and body. While some people experience fatigue and numbness, severe cases of MS can cause paralysis, vision loss, and diminished brain function. According to an estimate by the Multiple Sclerosis Association of America approximately 400,000 individuals in the US and 2.5 million people worldwide have MS, and the diagnosed patients are mostly in the age group of 15 - 50 years.
About Alkermes PLC
Dublin, Ireland, based Alkermes is a fully integrated global biopharmaceutical company that is a leader in innovative medicines that address the unmet needs and challenges of people living with debilitating diseases. The Company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction, and multiple sclerosis. The Company has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.
Last Close Stock Review
On Monday, October 30, 2017, Alkermes' stock closed the trading session at $48.89, slipping 1.93% from its previous closing price of $49.85. A total volume of 1.65 million shares were exchanged during the session, which was above the 3-month average volume of 748.84 thousand shares. The stock currently has a market cap of $8.28 billion.
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