Today, Halozyme Therapeutics, Inc., announced incredible news: The OCARINA II trial, evaluating Roche’s OCREVUS® (ocrelizumab) with Halozyme’s ENHANZE® as a twice-yearly, 10-minute subcutaneous injection, successfully achieved its primary and secondary objectives for both relapsing multiple sclerosis (MS) patients and primary progressive MS (RMS or PPMS) patients. This revolutionary breakthrough will drastically improve the quality of life for those suffering from this debilitating condition.
OCREVUS with ENHANZE®, Halozyme’s proprietary recombinant human hyaluronidase enzyme, rHuPh20 has proven itself to be just as effective given via subcutaneous injection as IV infusion. Its efficacy in controlling brain lesion activity as well as its safety profile are comparable to that of the intravenous version at 12 weeks. This innovative drug delivery method offers a more convenient option for those requiring treatment.
We are thrilled to share these groundbreaking Phase 3 results for an innovative subcutaneous form of OCREVUS with ENHANZE, which could provide people living with multiple sclerosis with a speedy and convenient treatment schedule that only requires 10 minutes of their time, twice a year.
Regulatory approval for this subcutaneous administration of OCREVUS with ENHANZE would make the treatment available in MS centers with either limited or no IV infrastructure, expanding the possibilities for patients to receive effective, time-saving therapy. As Dr. Helen Torley, president and chief executive officer of Halozyme, said: “This opens up the potential for people living with multiple sclerosis to receive their treatment […] in just 10 minutes, twice a year.”
OCREVUS with ENHANZE® Subcutaneous provides an additional delivery option for those suffering from Multiple Sclerosis, utilizing the successful twice-yearly dosing regimen of OCREVUS IV and offering patients and healthcare professionals a new level of convenience while maintaining the high levels of adherence and persistence of its standard of care predecessor.
Roche is thrilled to present the much-anticipated results of the OCARINA II trial at an upcoming medical meeting, and is committed to submitting the data for regulatory approval to health authorities around the world. With these data, Roche looks forward to revolutionizing patient care and further advancing global healthcare.
About the OCARINA II study
The OCARINA II study is exploring a new and innovative form of treatment of active cases of RMS and PPMS. Through a multicentre, randomised global study involving 236 patients, researchers are evaluating the pharmacokinetics, safety, and radiological and clinical effects of the subcutaneous form of OCREVUS versus IV infusion.
The primary endpoint is to ensure non-inferiority in the serum AUC from day one to 12 weeks. Meanwhile, secondary endpoints include the Cmax of OCREVUS, the number of active gadolinium-enhancing T1 lesions at 8 and 12 weeks, as well as new or enlarging T2 lesions at 12 and 24 weeks. This pioneering study will also assess patient-reported outcomes, safety, immunogenicity and biomarker results.
About Halozyme Therapeutics, Inc.
Halozyme is revolutionizing patient care through its innovative ENHANZE® technology. The biopharmaceutical company’s proprietary enzyme rHuPH20 has already helped over 700,000 people in over 100 global markets since its commercialization.
Now, its industry-leading technology is being used by some of the biggest names in pharmaceuticals including Roche, Takeda, Pfizer, AbbVie, Eli Lilly, Bristol-Myers Squibb, Alexion, argenx, Horizon Therapeutics, ViiV Healthcare and Chugai Pharmaceutical to significantly reduce the burden of treatment for patients and improve outcomes. With Halozyme’s ENHANZE® technology, a brighter, healthier future awaits!
Halozyme develops and commercializes specialized drug-device combination products that offer a range of advantages from convenience and tolerability to enhanced patient comfort and adherence. Their proprietary products include XYOSTED®, TLANDO® and NOCDURNA®, while development programs with several pharmaceutical companies, such as Teva Pharmaceutical, Pfizer and Idorsia Pharmaceuticals, are ongoing.
With these drug-device combinations, Halozyme is striving to provide patients with seamless, unprecedented health care experiences.
Headquartered in San Diego, CA, Halozyme is expanding its footprint across the US, with offices in Ewing, NJ and Minnetonka, MN. Not only are the Minnetonka offices Halozyme’s hub for operations, but they are also a symbol of the company’s drive to reach greater heights — a beacon for business growth and success.