Roche (RHHBY) yesterday announced new results from its Phase III METEOROID study showing that ENSPRYNG reduced the risk of relapse by 68% compared to placebo in patients with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD).
The trial met its primary endpoint, marking a potential breakthrough for a condition that currently has no approved treatment options.
MOGAD is a rare autoimmune disease of the central nervous system that can cause severe and unpredictable attacks on the optic nerves, spinal cord, and brain. The relapses often result in permanent neurological damage, vision loss, and disability.
The METEOROID study measured the time to first relapse during the double-blind treatment period, with results presented at the American Academy of Neurology (AAN) Annual Meeting in Chicago.
At 48 weeks, 87% of patients receiving ENSPRYNG (satralizumab)remained relapse-free compared to 67% on placebo. The therapy also reduced the annualized relapse rate by 66%, lowered the need for rescue therapies such as steroids or plasma exchange, and cut active lesions on MRI by 79%. Benefits were observed as early as eight weeks and were consistent across age, sex, race, and background therapy.
Safety findings were consistent with ENSPRYNG's established profile from its use in neuromyelitis optical spectrum disorder (NMOSD). Common side effects included injection-related reactions, influenza, back pain, Joint pain, sinusitis and diarrhea. No new safety signals were reported, and one fatality was deemed unrelated to treatment.
ENSPRYNG developed by Chugai, a Roche Group member, is a humanized monoclonal antibody that blocks interleukin-6 (IL-6) receptor activity. It is already approved in about 90 countries for NMOSD and has been used in more than 9,000 patients worldwide. With these new results, Roche plans to submit data to regulatory authorities, positioning ENSPRYNG as the first potential treatment for MOGAD.
Roche continues to expand ENSPRYNG's development into other autoimmune and inflammatory neurological diseases, including autoimmune encephalitis and thyroid eye disease, where positive Phase III results were announced recently.
RHHBY has traded between $35.07 and $60.85 over the past year. The stock closed Monday's trading at $49.93, down 2.73%.
For comments and feedback contact: editorial@rttnews.com
Business News
April 17, 2026 15:29 ET The ongoing conflict in the Middle East continues to raise concerns for policymakers who worry about the impact of the supply shock and high energy prices on the real economy. Producer price data and various survey results on the housing market were the main news from the U.S. this week. In Europe, industrial production data for the euro area gained attention. GDP figures out of China and the policy move by the Singapore central bank were in focus in Asia.