Halozyme announces Roche OCARINA II trial met primary, secondary endpoint

Halozyme (HALO) announced that Roche’s (RHHBY) Phase 3 OCARINA II trial evaluating Ocrevus with Enhanze as a twice a year 10-minute subcutaneous injection, met its primary and secondary endpoints in patients with relapsing forms of multiple sclerosis, or MS, or primary progressive MS. Ocrevus subcutaneous injection co-formulated with Enhanze, Halozyme’s proprietary recombinant human hyaluronidase enzyme, rHuPH20, was shown to be non-inferior to Ocrevus given by intravenous infusion, or IV, as measured by pharmacokinetics at 12 weeks. Ocrevus subcutaneous injection also was comparable to Ocrevus IV in controlling magnetic resonance imaging, or MRI, lesion activity in the brain over 12 weeks. The safety profile of OCREVUS subcutaneous injection was consistent with that of Ocrevus IV. The subcutaneous formulation of Ocrevus with Enhanze retains the twice-yearly dosing regimen of Ocrevus IV that has shown high persistence and adherence since becoming a standard of care MS treatment, potentially providing an additional delivery option for patients and healthcare professionals. Roche will share detailed results from the OCARINA II trial at an upcoming medical meeting and submit the data for regulatory approval to health authorities globally.