Roche is touting its multiple sclerosis (MS) drug as a potential game-changer in the field, asserting that it has achieved a significant milestone in biopharma: penetrating the blood-brain barrier. The Swiss pharmaceutical giant unveiled the results of its phase 2 FENopta study, involving 109 adults with relapsing MS, at the ECTRIMS-ACTRIMS meeting in Milan.
Roche’s BTK inhibitor, fenebrutinib, produced compelling outcomes in this study. It demonstrated a remarkable relative reduction of 90% in new or enlarging gadolinium-enhancing T1 lesions as detected by MRI scans after 12 weeks, meeting the trial’s primary endpoint. Similarly, it delivered a relative reduction of 95% in T2 lesions, a secondary endpoint.
Moreover, patients treated with fenebrutinib exhibited a four-fold increase in the likelihood of being free from new T1 Gd+ brain lesions or T2 brain lesions at weeks 4, 8, and 12 compared to those who received a placebo.
Roche also highlighted fenebrutinib’s capacity to traverse the blood-brain barrier, a feat rarely achieved in drug development. The company measured the drug’s concentration in the cerebrospinal fluid of a subgroup of 11 patients in the trial, revealing a mean fenebrutinib concentration of 43.1 ng/mL.
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While BTK inhibitor trials have often faced challenges related to adverse events, Roche’s latest trial reported a 38% adverse event rate for patients on fenebrutinib compared to 33% for those on a placebo. The most common adverse event not observed in the placebo group was elevated liver enzyme levels, reported in 5.5% of patients receiving fenebrutinib.
Fenebrutinib stands apart from rival candidates as a non-covalent BTK molecule, designed with a focus on offering long-term safety. However, Roche acknowledges that the true safety implications will become apparent in the ongoing phase 3 trials.
The stakes are high for Roche in these late-stage trials. In addition to two phase 3 studies in relapsing MS, the company has initiated a late-stage study in primary progressive MS, where fenebrutinib goes head-to-head with Roche’s own MS blockbuster, Ocrevus. While the timing of initial data from these trials remains uncertain, Roche is optimistic about the drug’s potential to transform MS treatment.
