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Genentech Announces New Data From Phase II FENopta Study Of Fenebrutinib For People With RMS
(RTTNews) - Genentech, Inc., a subsidiary of the Roche Group (RHHBY.PK) announced Friday new data from the Phase II FENopta study showing that investigational, oral fenebrutinib is brain penetrant and reduces brain lesions in people with relapsing multiple sclerosis (RMS). The data has a consistent safety profile to other fenebrutinib trials.
Brain penetrance was measured by the level of fenebrutinib in the cerebrospinal fluid (CSF) of a subgroup of 11 patients with RMS.
After 12 weeks of continuous treatment, the mean fenebrutinib concentration was 43.1 ng/mL. The level of fenebrutinib in the brain and central nervous system may conceivably become high enough to reduce MS disease activity and progression.
Fenebrutinib significantly reduced the total number of new T1 gadolinium-enhancing (T1 Gd+) brain lesions, and the total number of new or enlarging T2-weighted (T2) brain lesions.
A rapid onset of lesion reduction was observed by 4 weeks, with relative reductions of 92% and 90% in T1 Gd+ lesions and relative reductions of 90% and 95% in T2 lesions observed at 8 and 12 weeks, respectively.
Furthermore, patients treated with fenebrutinib were four times more likely to be free from any new T1 Gd+ brain lesions and new or enlarging T2 brain lesions at weeks 4, 8 and 12 combined, compared to patients who received placebo.
The safety profile of fenebrutinib was consistent with previous and ongoing fenebrutinib clinical trials across more than 2,500 people to date.
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