Lynk Pharmaceuticals has reported another phase 3 win in China for its next-gen JAK inhibitor, this time hitting skin clearance goals among patients with eczema.
The Hangzhou, China-based biotech assessed two oral doses of zemprocitinib against placebo in the late-stage study of 356 patients with moderate to severe atopic dermatitis (AD).
When it came to the proportion of patients who experienced a 75% or greater improvement in their eczema severity score, the 12-mg zemprocitinib cohort outperformed the placebo group by 38.1%. And the 24-mg treatment cohort saw a 46.4% difference, Lynk reported in a March 3 release.
The study also hit its other primary endpoint as measured by a more than two-point improvement on a global AD assessment. Specifically, the 12-mg cohort saw a 30% improvement over placebo while the 24-mg group saw a 31% improvement.
In addition, the study achieved statistically significant improvements in a range of other skin clearance, itching and life quality measures, according to Lynk.
Various JAK inhibitors are already marketed for AD, including AbbVie’s oral Rinvoq, Pfizer’s Cibinqo and Incyte’s topical Opzelura. Lynk has been pitching zemprocitinib as showcasing greater selectivity for JAK1 than first-gen inhibitors, leading the biotech to suggest its offering could maintain efficacy while reducing off-target adverse events.
Lynk continued to make the case in this morning’s release, pointing out that zemprocitinib’s safety profile “demonstrated competitive characteristics relative to other reported JAK inhibitors.”
JAK inhibitors have been associated with safety and tolerability problems—including increased risk of infection, cardiovascular events and death—that have led the FDA to slap boxed warnings on product labels. But Lynk noted that no serious adverse reactions related to decreases in hemoglobin, neutrophils or lymphocytes were observed in this morning’s data, and there were no safety concerns associated with elevations in the liver enzymes ALT or AST.
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Lynk CEO Zhao-Kui Wan, Ph.D., put this morning’s “highly encourag[ing]” results in the context of a phase 3 win for zemprocitinib in rheumatoid arthritis back in January.
“Following the successful phase 3 study in rheumatoid arthritis, this achievement represents another important milestone for zemprocitinib and further reinforces its positioning as a core asset in our pipeline,” the CEO added. “The favorable balance of efficacy and safety supports its potential differentiated profile in the competitive JAK landscape.”
Simcere partnered with Lynk to commercialize zemprocitinib in greater China in 2022. When Lynk filed (PDF) to go public in Hong Kong last November, the company said it planned to file for approval in rheumatoid arthritis in the second half of 2026. The company has previously said a filing for approval in AD, an indication not covered by the deal with Simcere, has been planned for the first half of the year.
Lynk has the rights to all indications outside China. The biotech offloaded the ex-China rights to another asset, an allosteric TYK2 inhibitor, to Formation Bio last month in a deal worth more than $600 million in biobucks.