Genentech commences clinical programs in MS with Fenebrutinib and Ocrevus

Roche (OTCQX:RHHBY) unit Genentech has initiated a Phase III clinical trial program for its investigational medicine fenebrutinib in multiple sclerosis (MS), along with a higher-dose program for Ocrevus (ocrelizumab) and a distinct Ocrevus trial.

The Phase III clinical trial program includes two identical trials in RMS (named FENhance 1 and FENhance 2) and one in progressive MS (PPMS) (named FENtrepid).

All three trials are targeting clinical disability progression and have a primary endpoint of 12-week composite confirmed disability progression (cCDP-12), with the addition of a co-primary endpoint of annualized relapse rate in the RMS trials. The PPMS study is the first study in this patient population to have an active comparator – Ocrevus – rather than placebo.

Ocrevus higher-dose Phase IIIb clinical trial program: Genentech is initiating two new Phase IIIb trials, one in RMS (named MUSETTE) and one in PPMS (named GAVOTTE), which will evaluate a higher Ocrevus dose compared with the currently approved 600 mg dose, with both evaluated at the twice-yearly (six-monthly) dosing schedule.

Ocrevus CHIMES trial in minority patients: The company recently commenced the Phase IV CHIMES (CHaracterization of ocrelizumab In Minorities with multiplE Sclerosis) trial in African-American and Hispanic- and Latinx-Americans with RMS. These patient populations are more likely to experience more relapses and greater disability than Caucasians, yet are vastly underrepresented in most clinical trials.

All of the newly announced clinical trials are underway and anticipated to begin recruiting in the coming months.

https://seekingalpha.com/news/3612361-genentech-commences-clinical-programs-in-ms-fenebrutinib-and-ocrevus