AAD 2025: Almirall presents early-stage pipeline progress and real-world evidence on demonstrating AK treatment success and patient satisfaction with Tirbanibulin
New data analysis on Tirbanibulin shows consistent treatment response for actinic keratosis (AK): data from phase IV and real-world evidence studies show consistently high levels of response as well as patient satisfaction.
Presentation of phase I data of the early-stage pipeline asset LAD191, a high affinity monoclonal antibody targeting IL-1RaP (interleukin-1 receptor accessory protein), which is expected to impact immune-modulated skin diseases by blocking multiple proinflammatory pathways.
Almirall´s strong presence at the AAD conference, sharing new data on Almirall’s dermatology and pipeline portfolio demonstrate its dedication to the medical community and patients living with skin diseases.
ORLANDO, Fla., March 07, 2025--(BUSINESS WIRE)--Almirall, S.A. (ALM), a global pharmaceutical company dedicated to medical dermatology presents five scientific posters at the 2025 American Academy of Dermatology (AAD) Annual Meeting - 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.
"Our close collaboration with the dermatology community and patients allows us to better understand their needs and develop effective solutions. 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," stated Dr. Volker Koscielny, Almirall’s Chief Medical Officer.
Tirbanibulin data: 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 data show the product´s demonstrated safety and tolerability profile through a combination of clinical trial data and real-world evidence. 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 Dr. Darrell Rigel, MD MS and 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."
LAD191 data: Almirall also presents 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.
Addressing Unmet Needs in Medical Dermatology
Medical dermatology remains a field with significant unmet needs, as many skin conditions still have limited treatment options. Dermatological diseases not only impact physical health but also affect emotional wellbeing and quality of life of patients. As a key participant in AAD 2025, Almirall continues to foster knowledge exchange and collaboration, reinforcing its commitment to deliver transformative dermatological solutions that improve patient lives.
With over 80 years of experience in healthcare, Almirall is committed to advancing science in dermatology through continuous investment in research and development and by fostering strong partnerships with the medical and scientific communities. The company's expanding portfolio in medical dermatology, particularly its focus on advanced biologic solutions for psoriasis and atopic dermatitis, underscores its dedication to improving dermatological treatments and enhancing patient outcomes.
Almirall´s presence at the AAD 2025 is an important opportunity to connect with healthcare professionals, partners, and industry peers at AAD 2025, a leading international forum for medical dermatology expertise and collaboration.
2025 AAD Annual Meeting poster details:
Five Almirall abstracts have been accepted by the AAD for their annual meeting.
Klisyri® (tirbanibulin)
1.
Patient outcomes and satisfaction with tirbanibulin for the treatment of actinic keratosis (AK): Results from real-world studies
2.
Relating patient-reported treatment satisfaction and clinical outcomes in real-world studies of tirbanibulin for actinic keratosis (AK)
3.
Safety and tolerability of tirbanibulin for the treatment of actinic keratosis (AK): Results from clinical trials and real-world studies
4.
Clearance of actinic keratosis (AK) with tirbanibulin: Comparing results from controlled trials with real-world clinical studies
LAD191
5.
Phase I single and multiple ascending-dose study to assess the safety, tolerability and pharmacokinetics of LAD191, a monoclonal antibody against the interleukin-1 receptor accessory protein (IL-1RaP), in healthy volunteers.
About Klisyri: Klisyri tirbanibulin ointment, 1% is a novel microtubule inhibitor indicated for the topical field treatment of actinic keratosis (AK) of the face or scalp. Klisyri has a demonstrated efficacy and safety profile, and a convenient 5-day application period, which is the shortest of any topical treatment for AK.1
IMPORTANT SAFETY INFORMATION
INDICATION
KLISYRI is a microtubule inhibitor indicated for the topical field treatment of actinic keratosis on the face or scalp.
WARNINGS AND PRECAUTIONS
Ophthalmic Adverse Reactions
Klisyri may cause eye irritation. Avoid transfer of the drug into the eyes and to the periocular area during and after application. Wash hands immediately after application. If accidental exposure occurs, instruct patient to flush eyes with water and seek medical care as soon as possible.
Local Skin Reactions
Local skin reactions, including severe reactions (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) in the treated area can occur after topical application of Klisyri. Avoid use until skin is healed from any previous drug, procedure, or surgical treatment. Occlusion after topical application of Klisyri is more likely to result in irritation.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥2%) were local skin reactions, application site pruritus, and application site pain.
Almirall is a global pharmaceutical company dedicated to medical dermatology. We closely collaborate with leading scientists, healthcare professionals, and patients to deliver our purpose: to transform the patients' world by helping them realize their hopes and dreams for a healthy life. We are at the forefront of science to deliver ground-breaking, differentiated medical dermatology innovations that address patients´ needs.
Almirall, founded in 1944 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM, total revenue in 2024: €990 MM, over 2000 employees globally). Almirall products help to improve the lives of patients every day and are available in over 100 countries.
