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Treatment with inebilizumab (VielaBio, Gaithersburg, MD) reduced relapses of neuromyelitis optica spectrum disorder (NMOSD) by 77% after 28 weeks of treatment. Response to treatment with inebilizumab for NMOSD was safe and effective such that the trial was terminated early as it was deemed unethical not to treat participants in the placebo arm of a phase 3 trial (NCT02200770). After this judgement was made, all participants in the placebo arm began receiving inebilizumab on an open-label extension basis. Treatment with inebilizumab also reduced worsening from baseline score on...
In a double-blind phase 2 study (NCT02975349), adult participants with multiple sclerosis (MS) who were treated with evobrutinib (EMD-Serono, Rockland, MA) (75 mg taken orally once or twice daily) had reduced numbers of T1 gadolinium enhancing (Gd+) lesions as early as 12 weeks after initiating treatment (Table 1). This reduction in T1 Gd+ lesions was maintained through week 48 of the study (Table 2). Participants treated with evobrutinib also had reduced annualized relapse rate (ARR) compared with those treated with placebo (Table 1), although this did not reach statistical...
The National Institute on Aging (NIA) has provided a 4-year grant for a phase 2 study of T3D-959 (T3D Therapeutics, Research Triangle Park, NC), a novel, metabolic-focused treatment for Alzheimer’s disease (AD). The PIONEER study, which will begin patient dosing in early 2020, is a double-blind placebo-controlled efficacy and safety study that will enroll up to 252 adults with mild-to-moderate AD. Participants in the study will receive 1 of 3 different oral doses of T3D-959 or placebo for 24 weeks. In a phase 2a study (NCT02560753), 34 participants with...
Umer Najib, MD, FAHS; Jessica Frey, MD; and David B. Watson, MD, FAHS, FAAN
Saif A. Bushnaq, MD; and Sunil A. Sheth, MD
Brian E. McGeeney, MD, MPH, MBA