UCBJY - UCB drug meets main goals of 2 phase 3 trials for painful skin disorder

UCB ( OTCPK:UCBJY ) ( OTCPK:UCBJF ) said its medicine bimekizumab met the main goal of two phase three studies to treat a skin condition called hidradenitis suppurativa

The studies dubbed BE HEARD I and BE HEARD II, evaluated bimekizumab in adults with moderate to severe hidradenitis suppurativa. BE HEARD I enrolled 505 people, while  BE HEARD II enrolled 509 patients.

Hidradenitis suppurativa is a condition which causes small, painful lumps to form under the skin, usually in areas where the skin rubs together, such as the armpits and groin, among others.

The company said that across the two studies, bimekizumab met the main goal, showing statistically significant and consistent clinically meaningful improvements over placebo in the proportion of patients who achieved the Hidradenitis Suppurativa Clinical Response (HiSCR50) at week 16.

HiSCR50 and HiSCR75 are defined as at least either a 50% or 75% reduction from baseline in the total pus and inflammatory nodule count, with no increase from baseline in pus or draining tunnel count.

The drug also showed depth of response with statistically significant improvements at week 16 over placebo in the percentage of patients achieving HiSCR75, which was a key secondary goal in both trials.

UCB added that the safety profile of bimekizumab in both trials was consistent with previously reported studies with no new safety signals.

"We are excited to announce positive pivotal Phase 3 outcomes in moderate to severe hidradenitis suppurativa which support our strong belief in bimekizumab and provide the first Phase 3 evidence suggesting that targeting IL-17F in addition to IL-17A may be a promising treatment approach," said Emmanuel Caeymaex, executive vice president, Immunology Solutions and head of U.S., UCB.

The company noted that data from these two studies will form the basis of global regulatory license applications for bimekizumab in hidradenitis suppurativa starting in Q3 2023.

Detailed results from the trials will be presented at an upcoming scientific meeting, according to the company.

In November, UCB reported results from three clinical trials of bimekizumab to treat psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis.

Bimekizumab is not approved in the U.S. but is approved in the EU under the name Bimzelx for plaque psoriasis.

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