Adamas Pharmaceuticals Inc., of Emeryville, Calif., said data from its phase II trial testing ADS-5102 (amantadine) extended-release capsules in multiple sclerosis patients with walking impairment were published in Multiple Sclerosis Journal. At week four, ADS-5102 produced a 17 percent improvement in walking speed, as assessed by a timed 25-foot walk, from baseline in the 56 intent-to-treat patients. The drug also helped a greater proportion of treated patients improve their walking speed by at least 20 percent from baseline compared to placebo. Adamas plans to start a phase III trial for ADS-5102 in multiple sclerosis patients with walking impairment in the second quarter of 2018.
Medicinova Inc., of La Jolla, Calif., reported data from the phase IIb SPRINT-MS trial testing MN-166 (ibudilast) in patients with progressive multiple sclerosis at the 3rd Annual Americas Committee for Treatment and Research in Multiple Sclerosis Forum 2018 in San Diego. MN-166 produced a 26 percent reduction in the risk of confirmed disability progression compared to placebo, as measured by the Expanded Disability Status Scale. Medicinova plans to meet with the FDA to plan the next step in development, noting that a phase III trial of approximately 700 patients would be sufficiently powered to achieve statistical significance for confirmed disability progression.
TG Therapeutics Inc., of New York, reported results from its ongoing phase II trial testing ublituximab (TG-1101), a glycoengineered anti-CD20 monoclonal antibody, in patients with the relapsing forms of multiple sclerosis (RMS) at the 3rd Annual Americas Committee for Treatment and Research in Multiple Sclerosis Forum 2018 in San Diego. Data from the first 40 patients treated with ublituximab showed a 99 percent median B-cell depletion at week four, which was maintained at week 24. T1 Gd-enhancing lesions were completely eliminated at week 24. Patients taking ublituximab had a mean Expanded Disability Status Scale (EDSS) improvement from baseline of 0.3 points with 78 percent of patients showing improved or stable EDSS. One of the 40 patients reported a relapse, but the patient was initially randomized to placebo and relapsed 12 days after the first infusion of ublituximab. TG is running two phase III trials, ULTIMATE I and ULTIMATE II, testing ublituximab for the treatment of RMS, which are scheduled to complete enrollment in the first quarter of 2019.