Biogen Idec’s closely-watched anti-LINGO-1 has shown evidence of biological repair of the visual system in a mid-stage trial.
The company has presented top-line results from an 82-patient Phase II study in patients with acute optic neuritis (AON). Anti-LINGO-1 demonstrated an improvement in the study’s primary endpoint, i.e. a 34% improvement in the recovery of optic nerve latency (time for a signal to travel from the retina to the visual cortex) relative to placebo.
However, the trial, called RENEW, was certainly not an unqualified success. Biogen noted that the treatment showed no effect on secondary endpoints, including change in thickness of the retinal layers and visual function. Furthermore, analysis of the intent-to-treat population showed a positive trend but did not reach statistical significance.
Nevertheless, Biogen chief medical officer Alfred Sandrock said “we believe the RENEW results are encouraging, as this is the first clinical trial to provide evidence of biological repair in the central nervous system by facilitating remyelination following an acute inflammatory injury”.
The huge excitement around anti-LINGO is principally based on the possibility that it could reverse the damage and scarring to the myelin sheath, the protective layer around nerves that characterises multiple sclerosis. A Phase II study, called SYNERGY, investigating anti-LINGO-1 in people with relapsing forms of MS, is ongoing and fully enrolled.
Dr Sandrock said Biogen is looking forward to the SYNERGY results in 2016 “to further advance our understanding of this molecule in MS, including a full-dose response”. He added that “the totality of the data from the two Phase II studies may provide us with a clearer understanding of anti-LINGO-1’s clinical potential”.