Dermira has wrapped the third and final psoriasis study of Cimzia, which the biotech says cleared the final hurdles in the lead up to an FDA filing later this year.
This latest study — triggered by a development deal Dermira struck with UCB in 2014 for US and EU rights to the rheumatoid arthritis drug — gathered up fresh evidence of Cimzia’s effectiveness in psoriasis, including a beat over Enbrel with a 400 mg dose at week 12 and noninferiority over Enbrel at 200 mg. The primary endpoint was the week 12 PASI 75 score on clearance, and the anti-TNF therapy came in at 66.7% for patients receiving the 400 mg dose every two weeks and 61.3.% for patients receiving the CIMZIA 200 mg dose every two weeks, compared to 5.0% for patients receiving placebo.
Those are respectable numbers, but psoriasis is a target for a full slate of new drugs coming in with big, disruptive Phase III results.
Nearly three-quarters of patients receiving J&J’s IL-23 star guselkumab (73.3%), for example, achieved a PASI 90 response, or near complete skin clearance, compared with 2.9% of patients receiving placebo. Brodalumab stumbled badly, but Eli Lilly made it onto the market with Taltz (ixekizumab) with Novartis out with the first new contender, Cosentyx. Merck is still in the clinic with MK-3222.
Dermira $DERM can now plan to launch a commercial operation in the US. Tom Wiggans, chief executive officer of Dermira, noted:
Both companies look forward to submitting these data to regulatory authorities to support a potential approval of Cimzia as a treatment option for moderate-to-severe chronic plaque psoriasis.
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