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  • Investigational monotherapy for NMOSD posts promising phase 3 results

    By Kanaga Rajan
    Genentech
    Neuro-Ophthalmology/Orbit
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    A novel monotherapy may reduce the risk of relapse for patients with neuromyelitis optica spectrum disorder (NMOSD), according to data presented by Genentech at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis.

    Satralizumab is an investigational monoclonal antibody that inhibits interleukin-6 signaling, a key contributor to inflammation-induced damage and disability in NMOSD. A separate phase 3 study previously hinted of the drug’s usefulness when combined with baseline therapy.

    “The positive phase III results for satralizumab, first as an add-on therapy and now as a monotherapy are exciting to see, and importantly, it achieved efficacy in a broad range of NMOSD patients, reflective of what we see in our everyday practice,” said Jeffrey Bennett, MD, professor of neurology and ophthalmology at the University of Colorado. “Approved treatment options demonstrating favorable safety and efficacy in controlled clinical trials are urgently needed. Even one relapse may lead to blindness and debilitating motor dysfunction for people with NMOSD.”

    The recent SAkuraStar trial comprised 95 adults with NMOSD who were randomized to receive satralizumab or placebo subcutaneously at 4-week intervals after 3 loading biweekly doses. Patients in the study arm experienced a 55% reduction in risk of relapse compared with placebo. More than 70% of patients remained relapse-free at 48 and 96 weeks. Satralizumab’s effect was most prominent among a subgroup of AQP4-IgG seropositive patients. Last year, the SAkuraSky study reported a 62% reduction of risk of relapse when satralizumab was combined with baseline therapy, regardless of AQP4-IgG status. 

    Overall, adverse events were generally mild to moderate and included urinary and upper respiratory tract infection, nasopharyngitis and headache. The company will continue to follow patients in open-label extensions of both phase 3 studies.

    “We are encouraged by these results and look forward to working with regulators over the coming months to bring satralizumab to people living with NMOSD as soon as possible,” said Sandra Horning, MD, Genentech’s chief medical officer and head of global product development.