UCB, a global biopharmaceutical company, has recently presented new interim data from BE BRIGHT, an open-label extension (OLE) trial of an interleukin (IL)-17A/F inhibitor ‘bimekizumab’ for plaque psoriasis (PsO), at the 2021 American Academy of Dermatology (AAD) Summer Meeting. While the data are still preliminary, they strongly support a potential approval for bimekizumab in PsO and will reinforce physicians’ positive opinions about the drug, according to GlobalData, a leading data and analytics company.
The presented data showed that among 1,335 patients with moderate and severe PsO, 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.
Tiffany Chan, Immunology Analyst at GlobalData, comments: “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: The US, France, Germany, Italy, Spain, and the UK) for moderate and severe PsO patients as early as next year.
Ms Chan adds: “Bimekizumab’s robust clinical program has made it a much-anticipated favorite among key opinion leaders (KOLs) interviewed by GlobalData.”
Although analysis of the full dataset will be required for physicians to draw their final conclusions, several 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.
Ms Chan continues: “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: 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 tumor necrosis factor (TNF) inhibitors (including UCB’s own Cimzia) and the newer class of IL-23 inhibitors.
Ms Chan concludes: “Despite these hurdles, KOLs interviewed by GlobalData believe that in addition to the impressive safety and efficacy, physician outreach and aggressive contracting can help establish bimekizumab’s place in this market, where UCB is already an active player.”