Roche Holdings AG (OTC:RHHBY) on Wednesday announced data from MUSETTE Phase 3 trial of a high dose of Ocrevus (ocrelizumab) intravenous (IV) infusion in adult patients with relapsing multiple sclerosis (RMS) compared with the currently approved Ocrevus IV 600 mg dose.

Patients received treatment with Ocrevus high dose or IV 600 mg every 24 weeks for a minimum of 120 weeks.

The trial did not meet its primary endpoint in showing additional benefit in slowing disability progression, as measured by a composite disability over a period of at least 120 weeks of treatment.

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The rates of disability progression were low and consistent with rates observed in the previous pivotal studies of Ocrevus IV 600 mg.

In addition, in several predefined analyses on disease activity, Ocrevus IV 600 mg showed clinically meaningful results with the lowest annualized relapse rate (ARR) observed during the double-blind period of a Phase III study in RMS.

The MUSETTE data further support the efficacy and safety profile of the currently approved OCREVUS IV 600 mg dose for RMS.

Ocrevus IV and Ocrevus subcutaneous (SC; marketed as OCREVUS ZUNOVO [ocrelizumab hyaluronidase-ocsq] in the U.S.) are approved for both RMS (including relapsing-remitting multiple sclerosis and active, or relapsing secondary progressive multiple sclerosis, as well as clinically isolated syndrome in the U.S.) and primary progressive multiple sclerosis.

Both Ocrevus IV and subcutaneous are administered every six months. The initial IV dose is given as two 300 mg infusions two weeks apart, with subsequent doses given as single 600 mg infusions.

Ocrevus subcutaneous is given as a single 920 mg subcutaneous injection every six months.

Price Action: RHHBY stock is down 3.89% at $39.48 at the last check Wednesday.

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