As UCB's bimekizumab inches toward a second shot at an FDA approval in psoriasis, the company is already looking ahead at a potential future indication.
At the American Academy of Dermatology's annual meeting on Saturday, UCB presented new data showing that results from two phase 3 trials testing the drug candidate in hidradenitis suppurativa held up through 48 weeks.
In the trials, dubbed BE HEARD I and BE HEARD II, bimekizumab previously showed statistically significant results over placebo at Week 16. Some patients even cleared the trials' shared primary endpoint, a 50% reduction of skin abscesses and inflammatory nodules, at Week 4.
At Week 16 in the trials, 47.8% of patients in BE HEARD I and 52% in BE HEARD II experienced the 50% reduction skin abscesses and inflammatory nodules. That compared with 28.7% and 32% for placebo, respectively. The patients also experienced “improved” quality of life as scored on a dermatology life-quality index.
In new 48-week data, UCB said more than 75% of patients maintained a 50% reduction in skin abscesses and inflammatory nodules in the studies. Around 55% of participants experienced a 75% reduction after 48 weeks of treatment.
The longer-term data give UCB confidence to pursue a potential second indication for its drug. The company aims to begin submitting applications in moderate to severe hidradenitis suppurativa by this year’s third quarter, UCB said in a statement.
Meanwhile, UCB expects to hear back on the drug's current application in psoriasis in the coming months.
Last May, the FDA handed UCB a complete response letter, rejecting its first psoriasis approval bid. In December, the FDA accepted UCB’s resubmission and gave the application a six-month review period.
In psoriasis, bimekizumab beat a tough competitor in Johnson & Johnson’s Stelara in a 2020 phase 3 trial, making the approval delay all the more frustrating for UCB. Bimekizumab has been approved already in the EU, Great Britain, Japan, China and Australia.
As for hidradenitis suppurativa, the primary market competition for UCB would be AbbVie’s powerhouse Humira. The chronic skin disease is hallmarked by nodules, abscesses and pus-discharging fistulas that emerge in flare-ups that come with severe pain.
Bimekizumab is a humanized monoclonal IgG1 antibody designed to selectively inhibit interleukin 17A (IL-17A) and interleukin 17F (IL-17F), which are two key cytokines that drive inflammatory processes.