UCB has announced new three-year data from its BE HEARD trials for BIMZELX (bimekizumab-bkzx), showing sustained improvements in patients with moderate-to-severe hidradenitis suppurativa (HS).

The findings, presented at the Symposium on Hidradenitis Suppurativa Advances (SHSA) 2025 in Nashville, highlight the long-term efficacy of the treatment in reducing painful lesions and skin pain.

Professor Steven Daveluy, Program Director at Wayne State University, explained: “Resolution of draining tunnels and abscesses is key for patients with HS because of the huge impact these lesions have on patients’ lives.”

Donatello Crocetta, Chief Medical Officer at UCB, said: “These results for bimekizumab show meaningful improvements in inflammatory lesions and skin pain to three years, and offer a valuable perspective on its deep and sustained efficacy for patients with HS.

“Our research presented at SHSA underscores UCB’s commitment to providing long-term data addressing key clinical features of chronic inflammatory conditions with a high unmet need.”

Of patients with at least one draining tunnel at baseline, 48.2% had none at one year and 62.9% at three years. Among those with no draining tunnels at baseline, 87.8% still had none at one year and 90.8% at three years.

Skin pain also improved, with only 10.0% reporting no/mild pain at baseline, rising to 51.7% at one year and 65.8% at three years.

UCB will present six abstracts on bimekizumab-bkzx in HS at SHSA 2025.

Alys Pharmaceuticals has announced the dosing of the first subject in its phase 1/1b trial of ALY-301, a first-in-class mast cell selective c-Kit inhibitor developed for the treatment of cold urticaria, a subtype of chronic inducible urticaria.

The multicentre study will enrol both healthy volunteers and patients with cold urticaria, with initial data expected in 2026.

The trial aims to evaluate safety, tolerability and pharmacology, as well as early signs of efficacy in patients who remain symptomatic despite antihistamines.

Professor Martin Metz, Principal Investigator for ALY-301, explained: “ALY-301’s ability to selectively target and deplete mast cells over other c-Kit positive cells, while potentially matching the efficacy of reference c-Kit inhibitors, gives it one of the most exciting profiles I have come across, highlighting the transformative potential of precision-targeted therapies in the immune-dermatology space.”

Professor Lars French, Chief Medical Officer of Alys Pharmaceuticals, added: “The initiation of this clinical trial is particularly exciting, as we will for the first time in patients, be able to assess the promising effects of our unique bispecific antibody ALY-301, designed to selectively inhibit mast cell c-Kit, whilst sparing other c-Kit expressing cells including melanocytes and hematopoietic stem cells.”