Almirall Presents Early-Stage Pipeline Progress for Tirbanibulin

Almirall, S.A. presented five scientific posters at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida, including new data on tirbanibulin, a topical treatment for actinic keratosis (AK), and progress of its early-stage asset LAD191, a high-affinity monoclonal antibody targeting interleukin-1 receptor accessory protein (IL-1RAP).

These presentations provide valuable insights into patient outcomes, safety, and real-world effectiveness of tirbanibulin for the treatment of AK and demonstrate the ongoing commitment of Almirall to finding novel solutions for skin diseases through progressing its early-stage clinical development pipeline, the company said in a press release.

"Our close collaboration with the dermatology community and patients allows us to better understand their needs and develop effective solutions,” Dr. Volker Koscielny, Almirall’s Chief Medical Officer, said in a press release. “The findings presented at AAD 2025 show our focus on delivering impactful data on our established products as well as progressing our early-stage pipeline. The data on tirbanibulin for the treatment of actinic keratosis highlight the importance of a patient-centered approach to achieve treatment success. Presenting data from the phase I study of our early-stage asset LAD191 is an important step towards adding new impactful treatments to our dermatology portfolio in the future.”

The new data analysis presented at the AAD demonstrates the impact of tirbanibulin on overall AK treatment success and clearance while also assessing patient satisfaction and willingness to continue the treatment, the company said. The analysis from Phase III, phase IV, and real-world studies provide further evidence for tirbanibulin´s tolerability, safety profile and patient satisfaction.

According to Darrell Rigel, MD, MS, Clinical Professor, Mount Sinai Icahn School of Medicine, "Patient satisfaction is a significant aspect of treatment outcomes. The results of these studies with tirbanibulin indicate notable improvements in patient satisfaction in real-world scenarios, which supports adherence to AK treatment protocols thus paving the way for more sustainable outcomes. By prioritizing patient experience and addressing their needs, the effectiveness of therapies can be enhanced, which can lead to an overall improvement in the quality of care."

Almirall also presented progress on its early-stage pipeline showing data from the Phase I clinical study with LAD191, a high-affinity monoclonal antibody targeting interleukin-1 receptor accessory protein (IL-1RAP), which is in development for the treatment of immune-modulated skin diseases such as hidradenitis suppurutiva. The results in healthy volunteers support the safety and tolerability and add to previous pre-clinical studies that have demonstrated LAD191’s ability to inhibit pro-inflammatory cytokines. Blocking multiple pathways through IL-1RaP inhibition is anticipated to provide greater clinical benefit in attenuating proinflammatory responses compared to single cytokine inhibition.