Corvus Pharmaceuticals released interim Phase 1 data for soquelitinib, an oral ITK inhibitor, in patients with moderate to severe atopic dermatitis. The data showed a favorable safety profile and promising efficacy, with the highest dose group (200mg twice daily) demonstrating the strongest response. Notably, improvements were observed in clinically significant endpoints like EASI 75 and IGA 0 or 1, even with a relatively short treatment duration of 28 days.
This news holds substantial potential for patients struggling with atopic dermatitis, especially those who haven’t responded to topical or systemic therapies. Soquelitinib’s novel mechanism, ITK inhibition, offers a different approach to managing the disease by targeting specific inflammatory pathways. The observed reduction in various inflammatory cytokines and potential increase in T regulatory cells suggests soquelitinib may not just treat symptoms but also modify the underlying disease process, which could lead to longer-lasting relief. This represents a potential advancement compared to existing treatments, which primarily focus on managing symptoms rather than addressing the root cause.
The Phase 1 trial included three dosing cohorts. Cohort 3, receiving 200mg twice daily, saw a 71.1% reduction in mean EASI score at 28 days compared to 42.1% in the placebo group. Cohorts 1 and 2, receiving lower doses, also showed improvements over placebo, though not as substantial as cohort 3. Importantly, soquelitinib was well-tolerated across all cohorts, with no dose-limiting toxicities or serious adverse events reported. Based on these positive results, Corvus has amended the trial protocol to include additional patients in the 200mg twice-daily group and extend the treatment period to eight weeks to further explore efficacy.
These interim results suggest soquelitinib could become a valuable new treatment option for atopic dermatitis. The upcoming Phase 2 trial will be crucial in confirming these early findings and optimizing dosing regimens. If the Phase 2 trial is successful, soquelitinib could significantly change the atopic dermatitis treatment landscape by providing a safe, effective, and potentially disease-modifying oral therapy.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
