Tirbanibulin

PARIS--(BUSINESS WIRE)--Almirall, S.A. (ALM) a global biopharmaceutical company dedicated to medical dermatology, is a major contributor to the 2025 European Academy of Dermatology and Venereology Congress (EADV) presenting new data across its broad portfolio of dermatological treatments including new real-world data of lebrikizumab on atopic dermatitis, new clinical data of tildrakizumab on psoriasis and tirbanibulin on actinic keratosis. The 34th EADV congress will take place from September 17 to 20 in Paris, France. At the congress, Almirall contributes a total of 44 scientific abstracts focused on advancing patient care across the company’s broad portfolio of dermatological treatments including atopic dermatitis, psoriasis, actinic keratosis, and hidradenitis suppurativa. With a strong emphasis on real-world evidence, patient-reported outcomes, and well-being, Almirall’s scientific programme includes multiple presentations, two expert-led symposia on psoriasis and atopic dermatitis, and an interactive exhibition booth supporting dermatologists in their daily practice and effective treatment choices for their patients. “The EADV congress is one of the most important platforms for exchange and learning about scientific and clinical advances in Dermatology. The Almirall team is excited to engage in conversations with leading experts and researchers to advance skin science and to develop meaningful solutions for patients. We are looking forward to discussing our new real-world evidence and clinical data for treatments across our broad portfolio to improve health outcomes for patients and support dermatologists in everyday practice,” said Dr. Volker Koscielny, Almirall’s Chief Medical Officer. Atopic Dermatitis: first real-world evidence study and new data on long-term efficacy and well-being of lebrikizumab Almirall presents interim results from the ADlife study, offering – for the first time - real-world evidence on the treatment of atopic dermatitis with lebrikizumab, featuring 100 patients treated for 16 weeks. The ADlife study demonstrates lebrikizumab is highly effective in treating moderate to severe atopic dermatitis with clinically relevant improvements in AD symptoms, already after 4 weeks of treatment, and a consistent safety profile. This data suggests that efficacy seen in randomized clinical trials translates well into the real-world setting - even in a more complex patient population. New data from the long-term extension ADjoin study shows that out of the patients showing significant improvement of their AD symptoms at week 16, those responses remained sustained after two-years of continuous treatment with lebrikizumab, as measured by absolute scores which are considered clinically relevant as they show response regardless of baseline severity. Further supporting its long-term efficacy, improvements in patient reported outcomes, such as itch and sleep (measured by POEM) were also observed up to 3 years of treatment with lebrikizumab. The ADvantage study – the first trial to utilize the WHO-5 Well-being Index in the assessment of an atopic dermatitis treatment – demonstrates the positive impact of lebrikizumab on holistic care for patients with moderate-to-severe atopic dermatitis who often show a significant impairment of their psychological well-being. Treatment with lebrikizumab was associated with improved psychological well-being in adult and adolescent patients to levels similar to a healthy population – already after 16 weeks - and were maintained for up to 52 weeks of treatment. Results from the ADvocate 1 and 2 studies reinforce lebrikizumab’s ability to deliver high rates of both skin clearance and itch relief after 16 weeks of treatment. First results were observed as early as week 4 compared to placebo and were maintained through to 52 weeks after treatment was initiated. Improvements in both the severity of the skin condition and itch translate into meaningful improvements in patient‑reported outcomes in atopic dermatitis1. Almirall’s symposium on atopic dermatitis, “Long-term control in Atopic Dermatitis: Elevating Therapeutic Goals” will be chaired by Prof. Sébastien Barbarot (France), and feature Prof. Tilo Biedermann (Germany), Prof. Richard Warren (UK), and Dr. Alessandra Narcisi (Italy). It will showcase new evidence on the role of IL-13 in AD pathogenesis, supporting the real-world evidence and the long-term efficacy of lebrikizumab delivering meaningful health benefits for patients. “Our symposium will highlight the unmet needs in atopic dermatitis and the pivotal role of IL-13 in disease pathophysiology. Through long-term data from clinical trials, real-world evidence and clinical cases, we’ll discuss how systemic biologic therapies like lebrikizumab are transforming care for patients and healthcare professionals”, commented Prof. Sébastien Barbarot. Psoriasis: advancing disease management and patient outcomes Almirall will present new effectiveness data on tildrakizumab for the treatment of moderate-to-severe plaque psoriasis from the real world ZODIPSO and CzATCH studies. These studies demonstrate high effectiveness of the treatment in high impact areas including nails, scalp, and the genital area. The TIL-SENIOR study explores the needs of elderly patients and how treatment with biologics like tildrakizumab can address these and offer a meaningful therapeutic option, while the TIL-TWO study shows how patients with elevated body weight or high-burden of disease can benefit from treatment with tildrakizumab 200 mg. The PROCARE-t study demonstrates high patient satisfaction with the psoriasis care provided by both hospital pharmacists and dermatologists during the treatment with tildrakizumab. Healthcare Professionals (HPCs) also expressed high satisfaction with the treatment showing the importance of multidisciplinary care in dermatology involving dermatologists and pharmacists. New data from the PRO-SCALP study show that CAL/BPD PAD(TM) cream delivers significant symptom relief of mild-to-moderate psoriasis of the scalp – which is particularly challenging to treat. It also demonstrated the treatment achieving enhanced emotional well-being, and overall improvements in daily life for patients. Almirall will also host a focused symposium on remaining unmet needs in psoriasis, “Psoriasis: Is there anything left to solve?”, Chaired by Prof. Jo Lambert (Belgium), with Dr. Andreas Pinter (Germany) and Dr. Pedro Mendes Bastos (Portugal). R&D pipeline: new insights on the treatment of large areas affected by Actinic Keratosis (AK), and phase I data on novel treatment for Hidradenitis Suppurativa (HS) Almirall will share new data from the TirbAKare study demonstrating tirbanibulin’s suitability for treating large skin areas of up to 100 cm2 affected by actinic keratosis. The results show that tirbanibulin provides statistically significant and clinically meaningful reduction in AK lesion count compared to vehicle at day 57 while offering a favorable safety profile. These results confirm tirbanibulin’s efficacy and tolerability, consistent with previous findings in controlled trials and real-world evidence when treating larger AK areas. Late-breaker: Phase I data on LAD191, a monoclonal antibody targeting the Interleukin-1 Receptor Accessory Protein (IL-1RAP), in patients affected by Hidradenitis Suppurativa suggest a favorable safety and tolerability profile, along with early signs of clinical improvement supporting the continued development of this asset. Advancing skin science at EADV 2025 Almirall’s booth at EADV (Pavilion 7.2, Booth D06) will offer visitors the opportunity to explore the latest innovations in dermatology and insights into patient needs through interactive educational content and global disease awareness initiatives. Highlights include: the global campaign, “Sanctuary Salon”, which educates about the impact of skin conditions on daily life and self-care, especially in the scalp area, a spotlight on the emotional burden experienced by AD patients, and the possibility for visitors contribute to a psoriasis patient association. About Almirall 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. For more information, please visit https://www.almirall.com/ Legal notice: This document includes only summary information and is not intended to be exhaustive. The facts, figures, and opinions contained in this document, in addition to the historical ones, are "forward-looking statements." These statements are based on the information currently available and the best estimates and assumptions that the Company considers reasonable. These statements involve risks and uncertainties beyond the control of the Company. Therefore, actual results may differ materially from those declared by such forward-looking statements. The Company expressly waives any obligation to revise or update any forward-looking statements, goals, or estimates contained in this document to reflect any changes in the assumptions, events, or circumstances on which such forward-looking statements are based, unless required by the applicable law. ANNEX: 34th EADV Congress presentations and poster details Satellite Symposium on psoriasis: Psoriasis: is there anything left to solve? Chair: Prof. Jo Lambert, Belgium Speakers: Dr. Andreas Pinter, Germany; Dr. Pedro Mendes Bastos, Portugal Thursday 18th September at 17:45 (CEST) / Room S06. Pavilion 7.3. Satellite Symposium on atopic dermatitis: Long-term control in Atopic Dermatitis: Elevating Therapeutic Goals. Chair: Prof. Sébastien Barbarot, France Speakers: Prof. Tilo Biedermann, Germany; Prof. Richard Warren, United Kingdom; Dr. Alessandra Narcisi, Italy. Friday, 19th September at 13:00 (CEST)/ Room S05, Pavilion 7.3. Full abstracts will be available on the EADV 2025 Congress platform from 07:00 CEST on 17 September 2025 – see full list of accepted abstracts below: Ebglyss® (lebrikizumab) Ilumetri® (tildrakizumab) Wynzora® (CAL/BDP) PAD™ Cream Klisyri® (tirbanibulin) and actinic keratosis LAD191 and Hidradenitis Suppurativa 1 Silverberg et al. J Dermatolog Treat 2024; 35(1):2428729.

ORLANDO, Fla.--(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. 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 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. Click here to view Full Prescribing Information. Reference: Klisyri [package insert]. Malvern, PA: Almirall, LLC. Content addressed for US audience only. About Almirall 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. For more information, please visit https://www.almirall.com/