Alkermes Reports Positive Data on Multiple Sclerosis Drug

Alkermes plc (ALKS) reported positive top-line data from a phase I study on its experimental multiple sclerosis (MS) drug, ALKS 8700. ALKS 8700 is a novel monomethyl fumarate (MMF) molecule being developed for the treatment of MS.

The three-part, randomized, double-blind phase I study was conducted to evaluate the safety, tolerability and pharmacokinetics (PK) of several oral formulations of ALKS 8700 as compared to both placebo and active control groups in 104 healthy volunteers.

Part 1 (n=56), a single-ascending-dose, placebo-controlled study evaluated the safety, tolerability and PK of a range of single doses (49 mg to 980 mg) of ALKS 8700 and a dose that would provide MMF exposure comparable to Biogen’s (BIIB) Tecfidera (240 mg). While part 2 (n=16) was a two-treatment, two-period crossover study that compared the PK and tolerability of either a single dose of ALKS 8700, Tecfidera or placebo, part 3 (n=32) evaluated PK of extended-release formulations of ALKS 8700.

Data from the phase 1 study revealed that ALKS 8700 provided MMF exposures with less variability and improved gastrointestinal (GI) tolerability when compared to Tecfidera. Patients reported lower GI-related adverse events when treated with ALKS 8700 (8.3%) as compared to Tecfidera (41.7%). Moreover, the candidate was also found to be well tolerated during the course of the study.

Encouraged by the positive results from the phase I study, Alkermes plans to conduct a meeting with the FDA and move a twice-daily dose of ALKS 8700 into a pivotal development program this year.

We are pleased with Alkermes’ progress with the candidate. According to data provided by the Multiple Sclerosis Association of America, nearly 400,000 individuals in the U.S. and 2.5 million people across the world suffer from MS. Once developed and approved, the new medication will provide patients with an alternative treatment option.

Alkermes has more data readouts lined up for 2015. We expect investor focus to remain on pipeline updates from the company.

Alkermes currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include Ophthotech Corporation (OPHT) and Prothena Corporation plc (PRTA). Both carry a Zacks Rank #1 (Strong Buy).

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