UCB Spotlights Bimekizumab And Other Later-Stage R&D Projects
Executive Summary
Belgium-headquartered UCB has a group of antibody-based products in mid to late-stage clinical studies which will be competing in the dermatology/immune disorders marketplace in the next few years.
Belgium’s mid-sized pharmaceutical company, UCB Group, has highlighted new understanding of the importance of axial spondyloarthritis and psoriatic arthritis, both of which are now believed to be more common than rheumatoid arthritis, as a factor in the development of its late-stage investigational selective IL-17A and IL-17F inhibitor, bimekizumab.
CEO Jean-Christophe Tellier reported that Phase III results involving bimekizumab are expected in the fourth quarter of this year, and a Phase III study of padsevonil, potentially the first anti-epileptic to target two receptors, has started in refractory patients.
Further, a proof-of-concept study has started with rozanolixizumab in chronic inflammatory demyelinating polyneuropathy (CIDP). Rozanolixizumab is already in Phase III in myasthenia gravis, with results expected in the first half of 2021, and a Phase III study in immune thrombocytopenia patients is expected to start in the fourth quarter of 2019, Tellier said in a 25 July call with analysts.
An anti-tau antibody, UCB-0107, is in a Phase I study in patients with progressive supranuclear palsy, Tellier added.
Bimekizumab currently features in eight late-stage studies by UCB, including three pivotal Phase III studies and a Phase IIIb study in psoriasis, two studies in psoriatic arthritis, one study in ankylosing spondylitis and one in non-radiographic axial spondyloarthritis, UCB executive vice-president and head of immunology patient value unit, Emmanuel Caeymaex said in the same call. “Four out of the eight studies have an active comparator arm, that includes the market leaders,” he noted.
With regards to the bimekizumab comparative studies in psoriasis, the comparators are AbbVie Inc.’s Humira (adalimumab) and Johnson & Johnson’s Stelara (ustekinumab), with results expected in the fourth quarter, and Novartis AG’s Cosentyx (secukinumab), with results expected in the second quarter of 2020. A Humira comparator is also being used in one of the psoriatic arthritis Phase III studies, from which results are expected in 2021.
The way moderate to severe psoriasis can evolve into potentially more daunting conditions was noted by the UCB executives. “If left untreated, moderate to severe psoriasis commonly leads to psoriatic arthritis and cardiovascular disease, but treatment rates are low and represents a market with significant market potential, remarked Caeymaex. (Also see "Psoriasis Drugs Poised For The Q2 Spotlight " - Scrip, 10 Jul, 2019.)
The market for psoriasis, psoriatic arthritis and axial spondylarthritis treatments is expected to grow to $37bn by 2027, Caeymaex noted, driven by IL-17 and IL-23 inhibitors. “In psoriasis, the IL-17s and IL-23s will gain the majority of dollar share as more patients gain access to systemic treatments, and as the treatment goals evolve towards sustained, totally clear skin and resolution of inflammation as a means to prevent co-morbidities,” Caeymaex added.
Recently Launched Products
The product developed in partnership with Amgen Inc., Evenity (romosozumab), has been approved now in the US, Japan, South Korea, Canada and Australia, although in the EU it has received a negative opinion by the CHMP, and UCB has requested a re-examination, which should take four to six months. (Also see "Amgen Launches Evenity For High-Risk Osteoporosis At $21,900 List Price" - Scrip, 15 Apr, 2019.)
"There is no reason for us to believe that a numeric imbalance in cardiovascular events, seen in one of our studies, is linked to Evenity, which has shown a strong benefit in patients with fragility fractures," Tellier remarked.
"UCB is the lead company for Evenity in Europe, and that for us is a clear priority and we are doing everything we can in order to have a positive outcome of the reexamination," he added. (Also see "‘Disappointed’ UCB And Amgen Will Appeal CHMP’s Negative Evenity Decision " - Scrip, 28 Jun, 2019.)
UCB has also gained approvals for Nayzilam (midazolam nasal spray) for acute repetitive seizures in the US this May. The product “completes our portfolio in epilepsy,” Tellier added. (Also see "Keeping Track: Novartis Scores Big Ahead Of US Memorial Day With Approvals For Gene Therapy Zolgensma, Oncologic Piqray" - Pink Sheet, 26 May, 2019.)