Look out Alexion, Roche breaks out the details on its rival rare CNS drug
Months after Alexion scored the first-ever approval for patients with neuromyelitis optica spectrum disorder (NMSOD) — researchers at Roche have come out with detailed data on their rival experimental drug satralizumab for use in the rare central nervous system disorder.
The 95-patient study dubbed SAkuraStar tested satralizumab against a placebo. Data showed satralizumab monotherapy conferred a 55% reduction in the risk of relapses compared to placebo in the overall population, representative of NMOSD patients (p=0.0184). In the overall satralizumab-treated population, 76.1% were relapse-free at 48 weeks, and 72.1% relapse-free at 96 weeks, versus 61.9% and 51.2% with placebo, respectively.
In addition, in the subgroup of patients that are AQP4-IgG seropositive — who tend to experience a more severe disease course — the effect of satralizumab was more stark. Patients on the drug saw a higher 74% reduction in risk of relapses. Data showed that 82.9% were relapse-free at 48 weeks and 76.5% relapse-free at 96 weeks when treated with satralizumab, compared to 55.4% and 41.1% with placebo, respectively.
Roche’s outgoing chief medical officer Sandra Horning added: “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.”
The disorder is often confused with multiple sclerosis as the immune system attacks its host, damaging healthy tissue in the spine and eyes. Although the majority of NMOSD patients are well managed on Rituxan, there are still about a third of patients who relapse and are at risk for severe disabilities and even death, if left untreated. Satralizumab inhibits IL-6 signaling, which is believed to play a key role in the inflammation that occurs in people with NMOSD.
Data from SAkuraStar adds to the results of the SAkuraSky study, which tested satralizumab in combination with baseline therapy for people with NMOSD. The data showed a 62% reduction in the risk of relapses when used in combination with baseline therapy compared to placebo (p=0.0184). The drug also conferred a 79% reduction in the risk of relapses in AQP4-IgG seropositive patients (p=0.0086).
In a note published following the Alexion’s Soliris approval in NMOSD, SVB Leerink’s Geoffrey Porges suggested that while there is no head-to-head comparison between Soliris and Roche’s drug, Soliris appears to have an edge on efficacy in relapsed patients.
Soliris was approved on the basis of the PREVENT study which tested the drug in anti-AQP4 antibody-positive patients. Data showed 98% of Soliris-treated patients were relapse-free versus 63% on placebo, at 48 weeks.
Porges forecast Soliris sales in NMOSD reaching about $700 million by 2024.
Viela’s CD-19 inhibitor, inebilizumab, also recently reported positive data from its pivotal NMOSD study.