AAN 2026 | Phase II ACUITY: privosegtor improves visual and neuroaxonal outcomes in acute optic neuritis

We are going to present the results of the Phase II trial, testing privosegtor in patients with acute optic neuritis. The trial has been conducted in five centers in France. It was a randomized double-blind placebo treatment. Patients were treated for five days, IV, as an add-on to standard of care, which is methylprednisolone, one hour infusion of methylprednisolone followed by two hours infusion of privosegtor or the placebo. Then we follow patients for six months with OCT with visual acuity with biomarkers neurofilaments and results are showing that in comparison with placebo patients treated with privosegtor have a significant recovery of the vision which is the most important thing meaning the low contrast visual acuity which is the one that is primarily impaired by more than three lines 18 letters and this was sustained from more three to more six which is a three letters is 15 letters is the cutoff that FDA requires to determine that these are clinically relevant. In addition to the high benefits in the vision at the OCT level meaning in terms of retina atrophy we found that the patients treated with privosegtor have a significant protection, meaning reduction in the thinning of the retinal ganglion cell layer and the RNFL layer, which are indicators of neural actual protection by the treatment. In terms of safety, safety was great, meaning no serious adverse events, no adverse event that led to the withdrawal meaning this was excellent. Also we did a subgroup analysis based on the presence of MS at baseline or not or the severity of presentation in terms of high contrast visual activity 60 letters and again the benefits in in in the clinical outcomes, the vision was maintained. And finally, very exciting, the role of biomarkers. Neurofilaments is a biomarker of axonal damage. And in patients treated with placebo, they have a significant increase and then decrease a little bit, but remain high. And in patients treated with privosegtor, they have a very, very tiny increase and remain very low for the beginning, which again, support this role in protecting axons and having this neuroprotective activity. Therefore, meaning safety was very good. We have evidence of clinical efficacy and efficacy of the biomarker and anatomical level, which means that the privosegtor now is becoming a highly promising therapy for treating optic neuritis and other relapses of MS and even other diseases in which axons have been damaged in brain diseases. We are very excited and we are moving to the Phase III trial in optic neuritis, most likely in another Phase III trial in relapses of MS with motor impairment, for example, in order to bring this drug to patients.

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