Jason Mast
Editor
Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one.
Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms.
The FDA has become increasingly skeptical of JAK inhibitors since they first approved Pfizer’s Xeljanz in 2013, most recently rebuffing Gilead’s filgotinib and demanding to see more safety data. The same questions have dogged baricitinib and Xeljanz, which recently failed the safety study the FDA required when they OK’d the drug.
Still, unlike rheumatoid arthritis, where Gilead was seeking approval, alopecia areata has no approved treatments. And Lilly tested 2mg and 4mg in the study, both lower doses than the 5mg that raised the biggest concerns at the agency. The FDA has also granted Lilly breakthrough designation for the disease, suggesting they are willing to work closely with the drugmaker to get it across the finish line.
Lotus Mallbris
The process will likely begin after they will first have to prove the drug works in a second Phase III trial, if it confirms the results of the first Phase III. That study is due to read out in the next couple months.
An approval could provide a path for Lilly to take a rare toehold in the JAK race. Pfizer has also studied its inhibitors in alopecia and has received breakthrough designation, but they remain behind in development. A JAK3 inhibitor, called ritlecitinib, is now in Phase II/III.
Lilly is also trying to grab the first JAK approval for lupus, where they remain two phases ahead of Merck and a phase ahead of AbbVie.
“For patients who suffer from alopecia areata, it is not a cosmetic condition, it is a devastating autoimmune disease that can have significant psychological effects. They lose much more than just hair,” Lotus Mallbris, Lilly’s VP of immunology, said in a statement. “We are looking forward to sharing the totality of data from the overall clinical development program for baricitinib as a potential first-in-disease treatment for alopecia areata.”
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