UCB's bimekizumab blows J&J's Stelara away in phase 3, raising expectations for Cosentyx showdown

UCB has presented detailed phase 3 data on psoriasis prospect bimekizumab, raising expectations that it can deliver a telling blow to Novartis’ Cosentyx in an upcoming head-to-head study. Shares in UCB, a company valued above $20 billion, jumped 14% in response to the readout. 

In October, UCB revealed its bispecific inhibitor of IL-17A and IL-17F had beaten Johnson & Johnson’s Stelara in a phase 3 psoriasis trial. The readout, which sent UCB shares up 5%, lacked numbers to show exactly how well bimekizumab performed and inform predictions of whether it can outperform AbbVie’s Humira and Novartis’ Cosentyx in additional studies.

UCB used the virtual American Academy of Dermatology meeting to share those numbers. In one of its presentations, UCB revealed that 85% of subjects who received bimekizumab experienced a 90% or greater reduction in the area and severity of their symptoms 16 weeks after starting treatment. Complete skin clearance, PASI 100, happened in 59% of patients.

The figures are higher than those generated by Stelara, which triggered PASI 90 and PASI 100 in 50% and 21% of patients, respectively. Perhaps more importantly, the numbers compare favorably to the results of other studies of Novartis’ fast-growing blockbuster Cosentyx.

Across its phase 3 program, Novartis linked Cosentyx to PASI 100 rates ranging from 37% to 45%. The unreliability of cross-trial comparisons makes it impossible to draw firm conclusions about the odds of UCB besting Novartis’ drug, but analysts at Jefferies think the results shared by UCB “increase the possibility that bimekizumab could be superior to entrenched Cosentyx in the upcoming BE RADIANT head-to-head trial.” Data from the head-to-head trial are due in about one month.

The data from the Cosentyx trial could be worth a lot to UCB. The Jefferies analysts currently expect annual sales of bimekizumab to top out around $1.5 billion. If bimekizumab beats Cosentyx, the sales forecast could rise to above $2 billion.

One doubt is whether UCB is equipped to maximize sales of bimekizumab in a psoriasis market that, in the words of the Jefferies analysts, is “dominated by competitors with large marketing budgets.” One way around that issue would be for UCB to bring a partner on board to commercialize bimekizumab.

If UCB goes looking for a partner, it will enter negotiations armed with data showing bimekizumab is a safe, efficacious, fast-acting and durable medicine. More than three-quarters of patients reached PASI 75 within four weeks of starting treatment with bimekizumab, and the PASI 100 rate rose to 64% by the 52-week mark. Most adverse events in the bimekizumab arms of the phase 3 trials were mild to moderate cases of nasopharyngitis, oral candidiasis and upper respiratory tract infections.