Positive Results Announced from Phase 3 OCARINA II Trial Evaluating Roche's OCREVUS® (ocrelizumab) with Halozyme's ENHANZE® Drug Delivery Technology in Patients with Multiple Sclerosis

About this update from Halozyme Therapeutics, Inc.

[{"type":"text","content":"SAN DIEGO, July 13, 2023 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (\"Halozyme\") today announced that Roche's Phase 3 OCARINA II trial evaluating OCREVUS® (ocrelizumab) with ENHANZE® as a twice a year 10-minute subcutaneous (SC) injection, met its primary and secondary endpoints in patients with relapsing forms of multiple sclerosis (MS) or primary progressive MS (RMS or PPMS).\nOCREVUS 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 (IV) as measured by pharmacokinetics (levels in the blood) at 12 weeks. OCREVUS subcutaneous injection also was comparable to OCREVUS IV in controlling magnetic resonance imaging (MRI) lesion activity in the brain over 12 weeks. The safety profile of OCREVUS subcutaneous injection was consistent with that of OCREVUS IV.\n\"We are delighted that these positive Phase 3 data for OCREVUS administered subcutaneously with ENHANZE opens up the potential for people living with multiple sclerosis to receive their treatment in just 10 minutes, twice a year,\" said Dr. Helen Torley, president and chief executive officer of Halozyme. \"Regulatory Authority approval of subcutaneous administration of OCREVUS with ENHANZE would create the possibility to administer OCREVUS in additional MS centers without IV infrastructure or with IV capacity constraints.\"\nThe 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.\nRoche 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. \nAbout the OCARINA II study\nOCARINA II is a global Phase III multicentre, randomised study evaluating the pharmacokinetics, safety and radiological and clinical effects of the subcutaneous formulation of OCREVUS compared with OCREVUS IV in 236 patients with RMS or PPMS. The primary endpoint is non-inferiority in a serum model-predicted area under the curve (AUC) from day 1 to 12 weeks after subcutaneous injection compared to IV infusion. Seco...

More updates from Halozyme Therapeutics, Inc.