French pharmaceutical company Sanofi has announced positive results from a Phase II trial of its investigational anti-CD40L antibody, frexalimab.
In the trial, the drug was found to reduce brain lesions in patients with relapsing multiple sclerosis (MS).
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Frexalimab is designed to address both acute and chronic neuroinflammation in MS without causing lymphocyte depletion.
The drug is being developed by Sanofi under an exclusive licence from ImmuNext.
Part A of the double-blind, randomised, placebo-controlled trial tested high and low doses of frexalimab against a placebo in a 4:4:1:1 ratio over 12 weeks.
A decline in the number of new gadolinium-enhancing (GdE) T1 MRI brain lesions at week 12 was the trial’s primary endpoint.
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By GlobalDataIts secondary endpoints were further MRI-based efficacy measures and the tolerability, safety and pharmacokinetics of frexalimab.
After 12 weeks of initial treatment, participants on placebo transitioned to the frexalimab arms for the open-label Part B, which is currently in progress.
The data revealed 89% and 79% reduction in new GdE T1 brain lesions at week 12 in the high-dose and low-dose treatment arms respectively compared with placebo, meeting the primary endpoint.
Both doses also reduced new or enlarging T2 lesions, which was a secondary endpoint of the trial.
The effects on the primary endpoint were sustained over time, with a greater reduction seen in the high-dose frexalimab treatment arm, as 96% of participants did not have any new GdE T1-lesions by week 24.
Frexalimab was found to be well-tolerated, with Covid-19 and headache being the most common adverse events (≥5%) in any treatment group.
Sanofi has now begun Phase III clinical trials of frexalimab in relapsing MS and non-relapsing secondary progressive MS.
Earlier this month, Sanofi Vaccines signed a deal with clinical trial solutions provider Medidata to use its electronic clinical outcome assessment (eCOA) in vaccine studies.
