Sonelokimab Appears Safe, Effective for Chronic Psoriasis in Dose-Expansion Trial

By Adam Hochron
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A trial of sonelokimab (M1095)—a novel tri-specific nanobody targeting IL-17A and IL-17F—met its primary endpoints for the treatment of chronic psoriasis, according to a press release from the manufacturer. 

Researchers found the medication also has an extended half-life and better biodistribution than currently available treatments. 

The phase 2 trial included 313 patients at 41 centers across North America and Europe who received either one of four possible doses of sonelokimab or placebo. The trial also included an active control arm of patients who received secukinumab. 

According to results published in The Lancet, approximately one-third of patients who received the highest dose of the medication achieved PASI 90 at week 4. At week 8, the authors noted nearly 80% of patients had achieved PASI 90, and by week 24, nearly 60% of patients achieved PASI 100. 

“Chronic psoriasis has a significant negative impact on the health and quality of life of patients, and effective new treatments are in great need,” said Kristian Reich, MD, of the University Medical Center Hamburg-Eppendorf, in the release. “The positive results from this trial with sonelokimab are very encouraging as they demonstrate the speed of effect, durability, and tolerability of this novel tri-specific nanobody approach targeting both IL-17A and IL-17F in patients with plaque-type psoriasis.”

Most adverse events reported during the placebo-controlled period were mild to moderate, with nearly half of all patients experiencing at least one or more adverse events. The most frequently reported events were nasopharyngitis (13.5%) and pruritus (6.7%). The release noted that five patients treated with the experimental drug experienced serious adverse events, though none were determined to be related to the drug. Three patients who enrolled in the trial opted to withdraw due to an adverse event. 

Reich said in the release that phase 3 studies are “clearly warranted to confirm the benefits of sonelokimab and its potential to significantly improve upon existing therapeutic options.” 

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