On 7 August, UCB presented new interim data from the BE BRIGHT (NCT03598790) open-label extension trial of an interleukin (IL)-17A/F inhibitor, bimekizumab, for psoriasis (PsO) at the American Academy of Dermatology summer meeting.
The presented data showed that among 1,335 patients with moderate and severe plaque PsO, the majority of patients who had achieved complete or near-complete skin clearance after 16 weeks of treatment with bimekizumab maintained these responses for up to two years with continuous maintenance dosing every four or eight weeks. More specifically, at week 16, 87.5% of bimekizumab-treated patients achieved Investigator’s Global Assessment (IGA) 0/1, 75% achieved Body Surface Area (BSA) ≤1%, and 63% achieved Psoriasis Area and Severity Index (PASI) 100. Among the latter group of responders, 81% of those dosed every four weeks and 86% of patients dosed every eight weeks maintained their response up to week 48. While these data are still preliminary, they strongly support a potential approval for bimekizumab in PsO and will reinforce physicians’ positive opinions about the drug.
Bimekizumab has had a series of promising PsO clinical results in recent years. This latest finding supports the results from the earlier BE READY (NCT03410992) trial, in which 91% of patients dosed every four weeks were able to maintain their PASI 90 response at 56 weeks. In the Phase III BE VIVID (NCT03370133) trial, bimekizumab was statistically superior to both placebo and the IL-23 inhibitor ustekinumab at 52 weeks, as measured by the PASI90 and the IGA.
Bimekizumab is expected to launch in all seven major pharmaceutical markets (7MM, namely the US, France, Germany, Italy, Spain and the UK) for moderate and severe PsO patients as early as next year. Bimekizumab’s robust clinical programme has made it a much-anticipated favourite among key opinion leaders (KOLs) interviewed by GlobalData. Although analysis of the full dataset will be required for physicians to draw their final conclusions, many KOLs are optimistic about bimekizumab’s performance. This positive physician opinion is likely to correlate with strong uptake in the field, which, coupled with high levels of efficacy, could pave the way for higher pricing potential.
Despite impressive showings in clinical trials, bimekizumab is nonetheless entering a crowded field, both inside and outside the IL-17 inhibitor class. There are currently three IL-17 inhibitors marketed for PsO, namely Novartis’ Cosentyx (secukinumab), Eli Lilly’s Taltz (ixekizumab) and Bausch/Ortho Dermatologics’ Siliq/Lumicef (brodalumab). These agents are already facing heavy competition from other classes like the tumour necrosis factor (TNF) inhibitors, including UCB’s own Cimzia (certolizumab pegol), and the newer class of IL-23 inhibitors. Despite these hurdles, KOLs interviewed by GlobalData believe that in addition to impressive safety and efficacy, physician outreach and aggressive contracting can help establish bimekizumab’s place in this market.