Results of a phase II trial of a potential remyelination agent indicated it improved recovery of optic nerve latency, but other study endpoints were not achieved, according to a press release from Biogen Idec.
The participants were treated for acute optic neuritis, a condition that often occurs with multiple sclerosis (MS), with an anti-LINGO-1 monocloncal (BIIB033) antibody over the course of 6 weeks.
LINGO-1 is an inhibitor of oligodendrocyte precursor cell differention. Since oligodendrocytes maintain the myelin sheaths that protect nerve fibers, the anti-LINGO-1 treatment aims to prevent this inhibition.
The study included 82 patients in a placebo-controlled trial. Biogen Idec reported that participants who received BIIB033 experienced a 34% improvement in the recovery of optic nerve latency, which was the study’s primary endpoint.
Despite this improvement, the intent-to-treat endpoint was still missed. Additionally, no benefits were seen in secondary outcomes, including low-contrast visual acuity, changes in thickness of retinal layers, or optical coherence tomography findings. The company did not release any other details about the treatment’s efficacy.
BIIIB033 is also being tested in a phase II trial called SYNERGY. In this study, the drug is being used to treat patients with relapsing-remitting and secondary progressing MS. The trial results are expected to be released next year.
Six weeks of treatment in a midstage clinical trial with a potential remyelination agent led to increases in a measure of optic nerve conduction in patients with acute optic neuritis, a condition often seen in conjunction with multiple sclerosis, the drug’s sponsor said.
In the placebo-controlled, 82-patient phase II RENEW trial, a per-protocol analysis showed that those receiving the anti-LINGO-1 monoclonal antibody experienced a 34% improvement in the recovery of optic nerve latency (P=0.0504), the study’s primary endpoint, according to a statement from Biogen Idec.