Preliminary data from the Phase 3 EVOLVE-MS-1 trial shows that ALKS 8700 — an investigative therapy developed by Alkermes to treat relapsing forms of multiple sclerosis (MS) — has a good safety and tolerability profile.
The results were subject of a poster, “EVOLVE-MS-1: A Phase 3, Open-Label, Long-Term Safety Study of ALKS 8700 in Relapsing-Remitting Multiple Sclerosis,” that was presented Oct. 27 at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris.
ALKS 8700 is an oral compound. Once inside the body, it is rapidly transformed into the therapeutic compound monomethyl fumarate (MMF). Although similar, this drug candidate was designed to offer features different than those achieved with the commercially available Tecfidera (dimethyl fumarate).
“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 [gastrointestinal] side effects that may lead to treatment interruption or discontinuation, particularly in the first few weeks following treatment initiation,” Dr. Robert Naismith, associate professor of neurology at the Washington University School of Medicine in St. Louis, said in a press release. “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.”
Alkermes is currently assessing the safety and efficacy of ALKS 8700 in the EVOLVE-MS program (Endeavoring to Advance Treatment for Patients Living with Multiple Sclerosis), which includes two Phase 3 clinical trials in patients with relapsing-remitting MS (RRMS).
The EVOLVE-MS-1 (NCT02634307) is a two-year study being conducted in 107 U.S. and European research sites. It will evaluate the long-term safety of ALKS 8700 in some 930 RRMS patients.
Interim data collected during the first month of treating 580 participants showed low incidence of GI adverse events, with no reports of serious events. The most common adverse side effects associated with the treatment were flushing, pruritus and diarrhea.
Alkermes, which is based in Ireland, said additional results from the initial three months of treatment further supported the positive safety data of ALKS 8700, with only 2.3 percent of patients reporting serious adverse events and 3.7 percent having to stop treatment.
“We are encouraged by the safety data presented 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,” said Dr. Elliot Ehrich, executive vice president of research and development at Alkermes.
The EVOLVE-MS-2 trial (NCT03093324), being conducted at 48 U.S. sites, will compare the safety and efficacy of ALKS 8700 versus Tecfidera in RRMS patients. The study is still recruiting participants.
Recent data of EVOLVE-MS-2 was also subject of a poster presentation at the ECTRIMS-ACTRIMS Meeting.
“We are committed to bringing this potential valuable new treatment to patients and providers,” said Ehrich, “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.”
