 |
| Alkermes Chief Medical Officer Elliot Ehrich |
Alkermes ($ALKS) has its sights set on Biogen Idec's ($BIIB) blockbuster multiple sclerosis treatment, advancing a me-better candidate of its own into Phase I study.
ALKS 8700 is a novel drug designed to convert to monomethyl fumarate in the body and relieve MS symptoms. The biotech is kicking off a 125-patient, randomized Phase I trial to determine the safety and tolerability of multiple formulations and doses of the oral drug, looking to nail down the ideal setup for further study.
Tecfidera, Biogen's multibillion-dollar oral MS treatment, is a twice-daily drug that uses the active ingredient dimethyl fumarate to suppress the immune systems and treat the disease. Alkermes believes it has a shot at developing a successor that will allow for once-a-day dosing with fewer side effects, and ALKS 8700's first clinical trial will light the way for what could be a disruptive force in the MS market.
"We expect the results of this study to be highly informative and determine the therapeutic utility and differentiating features of ALKS 8700," Chief Medical Officer Elliot Ehrich said in a statement. "ALKS 8700 leverages Alkermes' expertise in prodrug chemistry and oral controlled-release formulations to offer potential differentiated tolerability and dosing for patients with MS."
ALKS 8700 is the leader among Alkermes' latest crop of pipeline therapies, which includes the preclinical ALKS 7106, an abuse-deterrent pain drug, and RDB 1419, an IL-2 immunotherapy for cancer. The biotech is focused on therapeutics that allow it to use its know-how in drug delivery and novel formulations to improve upon best-selling drugs, CEO Richard Pops has said, a philosophy that extends to its later-stage pipeline, highlighted by the schizophrenia treatment ALKS 3831 and depression drug ALKS 5461.
Tecfidera, formerly BG-12, has soared since launching last year, bringing in $1.4 billion in its first four quarters on the market and taking pole position in the MS market.
- read the announcement