Dive Brief:
- Eli Lilly & Co. and partner Incyte Inc. on Thursday announced mixed data from a Phase 2 trial of their Janus kinase (JAK) 1/2 inhibitor in patients with atopic dermatitis at the European Academy of Dermatology and Venereology annual meeting in Geneva.
- After 16 weeks of treatment, 61% of patients treated with a 4 mg dose of baricitinib plus topical steroids achieved a 50% or greater reduction in their overall disease severity, compared with only 37% of patients on topical steroids alone as measured by the Eczema Area and Severity Index (EASI-50).
- Yet, the 2 mg dose of the drug failed to reach statistical significance on the EASI-50 measure at 16 weeks. Neither dose of the drug showed a statistically significant difference from steroidal treatment in reducing disease severity by 75%.
Dive Insight:
While the results of the baricitinib trial in atopic dermatitis patients were successful at the 4 mg dose, the data may not be strong enough to give it a competitive edge against already marketed drugs.
Comparing drug performance across studies isn’t an exact science, but it can offer a look into how drugs will compete in the marketplace.
A Phase 2 study conducted by Sanofi SA and partner Regeneron for their since-approved drug Dupixent (dupilumab) showed 100% of patients on treatment achieved 50% skin clearance at four weeks. Only 68% of patients treated with 4 mg baricitinib, on the other hand, met that mark in Lilly's study.
Jefferies analyst Biren Amin called the baricitinib results "lackluster" when compared with Dupixent. "Given these outcomes, we see dupilumab as having greater potential for clinically meaningful improvement when combined with topical steroids," he wrote in a Sept. 14 note to clients.
Baricitinib has been a bit of a sore spot for Lilly. The drug has been closely watched and was touted as its next big blockbuster, but a rejection earlier this year from the Food and Drug Administration led to major delays.
Lilly recently announced it plans to refile by early next year, but the drug will have some catching up to do to Dupixent.