New results from the phase 3 SAkuraStar (NCT020737279) and SAkuraSky (NCT02028884) studies are being presented at the European Academy for Neurology Virtual Congress 2020 of satralizumab (Genentech, San Francisco, CA) for treatment for neuromyelitis optica spectrum disorder (NMOSD). The safety and tolerability results include adolescents, for whom no NMOSD treatment has been approved. Satralizumab is an investigational humanized monoclonal antibody that targets the interleukin-6 (IL-6) receptor, believed to play a key role in the inflammation that occurs in NMOSD. A novel anitbody recycling technology that allows a longer circulation of antibodies was used to produce satralizumab, alowwing for subcutaneous dosing every 4 weeks. As previously reported in Practical Neurology, satralizumab significantly increased the time to relapse in people with NMOSD.
Pooled data from the double-blind periods of the SAkuraStar and SAkuraSky Phase III studies showed rates of adverse events (AE) and serious adverse events (SAEs) were comparable between the therapy and placebo groups (SAEs: 15.0 vs 18.0 events/100 patient years, respectively), as a monotherapy or in combination with baseline therapy. In a separate analysis from the SAkuraSky study, adolescents treated with the therapy (n=8) demonstrated a benefit-risk profile generally consistent with the adult population.
In pharmacokinetic and pharmacodynamic analyses from phase 1 and these 2 pivotal phase 3 studies, the dosing regimen of satralizumab, 120mg every 4 weeks, showed significant, sustained IL-6 signaling inhibition, also suggesting that satralizumab, as both monotherapy and in combination with baseline immunosuppressant therapy, suggest that IL-6 inhibition may be an effective therapeutic approach for NMOSD.
“The open-label extension data from the phase 3 studies reinforce the safety, observed tolerability, and potential of satralizumab as a future treatment option for this chronic condition,” said Jerome de Seze, department head of Neurology and Clinical Investigation Centre, University of Strasbourg, France. “Although significant strides have been made recently in understanding NMOSD, more approved treatment options offering a well-tolerated safety profile with less frequent, subcutaneous dosing is needed for this underserved population.”