Roche, Genentech Initiate Trials For Fenebrutinib, OCREVUS In Multiple Sclerosis

Swiss drug maker Roche Group (RHHBY) and its U.S. unit Genentech announced Wednesday the initiation of an innovative Phase III clinical trial program for investigational medicine fenebrutinib in multiple sclerosis or MS.

The trial is initiated along with a higher-dose Phase III clinical trial program for Ocrevus (ocrelizumab) and a distinct Ocrevus trial specifically to support African-American and Hispanic- and Latinx-American patients with MS.

MS is a chronic disease that affects nearly 1 million people in the U.S. and more than 2.3 million people worldwide, for which there is currently no cure.

The Phase III clinical trial program includes two identical Phase III trials in relapsing MS or RMS and one Phase III trial in primary progressive MS or PPMS.

All three trials are targeting clinical disability progression and have a primary endpoint of 12-week composite confirmed disability progression or cCDP-12, with the addition of a co-primary endpoint of annualized relapse rate in the RMS trials.

The companies are initiating a Phase III clinical trial program for fenebrutinib, an investigational oral Bruton’s tyrosine kinase or BTK inhibitor in RMS and PPMS.

Further, Phase IIIb clinical trial program of higher-dose OCREVUS, compared with the currently approved 600 mg dose, is to evaluate impact on reducing disability progression in RMS and PPMS.

At the currently approved 600 mg dose, Ocrevus is the only MS treatment that has showed a consistent and significant impact on slowing disability progression in both RMS and PPMS Phase III studies.

The companies will present the overviews of clinical trials and scientific rationale at MSVirtual2020, the 8th Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis or ACTRIMS and the European Committee for Treatment and Research in Multiple Sclerosis or ECTRIMS from September 11-13, 2020.

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