Novartis plans BTK inhibitor filing in chronic spontaneous urticaria as Celldex’s mid-stage data excites investors

No­var­tis un­veiled pos­i­tive reg­is­tra­tional da­ta for its BTK in­hibitor can­di­date in chron­ic spon­ta­neous ur­ticaria, trig­ger­ing plans for reg­u­la­to­ry fil­ings.

But strong Phase II read­out from Celldex Ther­a­peu­tics pub­lished on Mon­day sug­gests No­var­tis has a po­ten­tial ri­val in the works. Celldex’s share price $CLDX rock­et­ed by 20% to $32 in re­sponse to Mon­day’s da­ta.

No­var­tis’ REMIX-1 and REMIX-2 are iden­ti­cal place­bo-con­trolled Phase III tri­als eval­u­at­ing remi­bru­ti­nib in more than 450 CSU pa­tients each. In REMIX-1’s pri­ma­ry end­point, remi­bru­ti­nib reached a mean 20.1-point re­duc­tion from base­line in the sev­en-day Ur­ticaria Ac­tiv­i­ty Score (UAS7) ver­sus a 13.8-point re­duc­tion with place­bo at 12 weeks. The drug al­so saw a mean 19.6-point UAS7 re­duc­tion in REMIX-2 ver­sus an 11.7-point in the place­bo group. Around a third of treat­ed pa­tients were free of itch and hives at 12 weeks.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.