Alkermes plc, a fully integrated global biopharmaceutical company, recently provided a regulatory update and positive clinical trial data for ALKS 8700, an oral, innovative and proprietary monomethyl fumarate (MMF) compound that is being developed to treat multiple sclerosis (MS).
ALKS 8700 is being developed to quickly and efficiently convert to MMF in the MS patient’s body and to provide differentiated qualities in comparison with the marketed TECFIDERA® (dimethyl fumarate) currently used to treat relapsing forms of MS.
Regulatory update: Following a meeting with the U.S. Food and Drug Administration (FDA), the company is planning to submit a 505(b)(2) New Drug Application (NDA) using pharmacokinetic results from clinical studies that compared ALKS 8700 and TECFIDERA, as well as from a two-year phase 3 clinical study assessing the safety of ALKS 8700 in about 600 MS patients. This means that the company will not be obligated to conduct another phase 3 study assessing the safety of the drug in MS patients. Alkermes also plans to begin by mid-2016 a head-to-head randomized trial in which ALKS 8700 gastrointestinal (GI) tolerability will be compared to TECFIDERA in about 420 MS patients.
The company anticipates completing these clinical trials and filing the NDA in 2018.
Positive Clinical Data: Alkermes recently finished a double-blind, randomized, phase 1 comparative pharmacokinetic clinical study assessing the achieved levels of plasma MMF by administration of single ALKS 8700 and TECFIDERA doses. Initial results from this clinical study revealed that ALKS 8700 met the pharmacokinetic standards for bioequivalence to TECFIDERA.
In terms of adverse events observed in this clinical study, the most commonly reported were dizziness, flushing, and constipation for those MS patients that were treated with ALKS 8700, and nausea, flushing, and diarrhea for MS patients treated with TECFIDERA.
Based on the reported clinical data, the company has chosen the dose of ALKS 8700 that is going to be used in the registration clinical program. Alkermes is required to conduct supplementary pharmacokinetic and preclinical studies to further backing pharmacokinetic TECFIDERA’s comparability.
“With these positive pharmacokinetic bridging results and agreement with the FDA on our regulatory strategy in hand, our path to approval for ALKS 8700 has been clarified. A key component of the program is the comparison of GI tolerability, as we see this as an opportunity to potentially provide new benefits to MS patients,” said Elliot Ehrich, MD, Chief Medical Officer of Alkermes, in a press release. “We remain on track to advance ALKS 8700 twice-daily into phase 3 development with the initiation of the two-year safety study later this year, and we plan to file the NDA in 2018.”
In the U.S., approximately 400,000 individuals have MS, a disabling central nervous system (CNS) disease that interrupts the flow of information within the brain, and between the brain and body.