Tirbanibulin

Actinic keratosis is a pre-cancerous area of thick, scaly, or crusty skin. Credit: Douglas Cliff via Shutterstock. Vidac Pharma has secured €600,000 ($645,651) in additional funding to support the clinical development of its two lead cancer candidates. The funding from existing investors, announced at the company’s recent shareholder meeting, will enable Vidac to initiate a new Phase IIb trial for its lead candidate VDA-1102 (tuvatexib) ointment. The hexokinase 2 inhibitor is being investigated in advanced cases of actinic keratosis, a skin condition that can progress to cutaneous squamous cell carcinoma (SCC). Alongside VDA-1102, the UK-based biotech continues preclinical studies of VDA-1275. Both candidates target the metabolic pathways of cancer cells by disrupting hexokinase 2 interactions with mitochondrial channels, aiming to reverse the high-energy demands of tumours and promote cancer cell death. VDA-1275 is being developed as a systemic drug for the treatment of solid tumours. Interim data from a Phase IIa study (NCT02844777) released in January 2023 showed a 56% objective response rate (ORR), with 22% complete responses (CR), observed between eight and 12 weeks. This compares to the standard-of-care treatment mechlorethamine, which has a 13% CR and a longer median response time of 26 weeks. Final results are expected in Q4 2024. Vidac has also completed a Phase IIb clinical trial (NCT03538951) for VDA-1102 in actinic keratosis. In a post-hoc analysis, the therapy demonstrated a 40% complete clearance of lesions and an 80% overall reduction in lesion count. The study also indicated that patients with advanced actinic keratosis responded more favourably to the treatment than those with less severe forms. Based on these findings, the upcoming Phase IIb trial will focus specifically on patients with advanced actinic keratosis. Unlike conventional actinic keratosis treatments that directly destroy abnormal cells, through topical therapies, cryotherapy, or photodynamic therapy, VDA-1102 works by reprogramming cancer cell metabolism. This selective approach aims to spare healthy cells, and in the Phase IIa trial, resulted mostly in mild, localised side effects, with one moderate case. Standard actinic keratosis treatments, by contrast, can cause skin inflammation, scaling, or burning, and are often invasive. In the announcement accompanying the funding, Vidac’s CEO Max Herzberg said: “I want to thank our board, advisers, team and shareholders for their support for our entirely new approach in oncology, with drugs that reverse the supercharged metabolism of cancer cells.” In June 2024, Almirall ’s Klisyri (tirbanibulin) secured FDA-expanded approval to treat larger actinic keratosis areas to up to 100cm² from the previous maximum of 25cm². Klisyri works by blocking cell division and killing abnormal cells. The most common side effects are local skin reactions, including erythema (reddening of the skin), flaking/scaling, crusting, swelling and the formation of sores and ulcers. Innovations in the pharma and medical device landscape are looking to expedite the diagnosis of skin cancers. In July 2023, the National Cancer Institute (NCI), part of the US National Institutes of Health (NIH), awarded $2m in funding to Enspectra Health through the Small Business Innovation Research (SBIR) programme. The grant will fund the development of deep learning algorithms that can predict which actinic keratosis skin lesions are likely to turn into SCC.

BARCELONA, Spain--( BUSINESS WIRE )-- Almirall, S.A. (ALM) , a global pharmaceutical company dedicated to medical dermatology, today announced its participation in the 33rd Congress of the European Academy of Dermatology and Venereology (EADV) , taking place in Amsterdam from September 25 to 28, 2024. This year, Almirall marks its 80th anniversary, celebrating eight decades of innovation and commitment to delivering products positively impacting people’s health and lives. At the congress, Almirall will present 34 abstracts detailing the latest research on lebrikizumab for moderate-to-severe atopic dermatitis in adolescents and adults, tildrakizumab and Almirall’s CAL/BDP cream for moderate-to-severe plaque psoriasis in adults, as well as tirbanibulin for actinic keratosis. The company will also host two symposia, providing a platform for experts to discuss current data, share insights, and facilitate discussions about the treatment of these chronic conditions with advanced biologics. Impact of the treatment of psoriasis on patient wellbeing: new data from the POSITIVE study Almirall will unveil new interim data on the treatment of adults with moderate-to-severe plaque psoriasis with tidrakizumab at 52 weeks from the POSITIVE clinical study. The POSITIVE study is the first clinical trial in dermatology to use the WHO-5 Wellbeing Index as a primary endpoint. The 5-item World Health Organization Wellbeing Index is a validated questionnaire that assesses health-related subjective psychological wellbeing in a variety of chronic diseases. The different sub-analyses presented during the congress reinforce the effectiveness of tildrakizumab on signs and symptoms in skin and beyond. Almirall will host the symposium "Advancing Psoriasis Management for Long-Term Patient Outcomes", featuring experts such as Prof. Dr. Diamant Thaçi from the University of Lübeck, Prof. Dr. Ulrich Mrowietz from the University Medical Center Schleswig-Holstein, and Prof. Anna López Ferrer from the Hospital de la Santa Creu i Sant Pau in Barcelona. The discussion will emphasize on the importance of tailoring treatments to individual patients , the latest real-world evidence, and practical strategies for clinical success managing psoriasis, with opportunities for interactive discussion with leading experts. Advancing atopic dermatitis disease management Almirall will also present new data on lebrikizumab, a biologic approved for the treatment of moderate-to-severe atopic dermatitis. The late-breaking presentation will report lebrikizumab’s data over three years of continuous treatment, alongside new data on the rates of absolute endpoints and its effectiveness in patients inadequately controlled or ineligible for cyclosporine. The Almirall symposium entitled "Precision in AD: How Lebrikizumab is Changing the Treatment Paradigm" will feature the experts Marjolein Bruin-Weller, from the National Expertise Center for Atopic Dermatitis at the Department of Dermatology and Allergology of the University Medical Center Utrecht; Andrew Blauvelt from Portland, US, and Sascha Gerdes from the Center for Inflammatory Skin Diseases of the University Medical Center Schleswig-Holstein Campus Kiel. Discussions will focus on the clinical impact of lebrikizumab and offer a chance for participants to engage with leading specialists in this field. Almirall celebrating 80 years of innovation 2024 marks a significant milestone for Almirall as the company celebrates 80 years of innovation and commitment to delivering impactful solutions to help improve patients’ lives. With a rich history in the pharmaceutical industry and a strong focus on medical dermatology, Almirall has built a robust pipeline addressing various diseases and using different therapeutic modalities. Leading innovating in medical dermatology is enabled by Almirall's close collaboration with the dermatology community and patient-centric mindset. Celebrating its 80 th anniversary, Almirall reaffirms its dedication to advancing skin science and developing novel treatments to benefit patients and the dermatology community around the world. For more information about Almirall’s 80th-anniversary celebrations, visit almirall80years.com ANNEX: 33 rd EADV Congress presentations and poster details: Satellite Symposium on psoriasis: Advancing Psoriasis Management for Long-Term Patient Outcomes - Chair, Prof. Dr. Diamant Thaçi, Lübeck, Germany - Prof. Dr. Anna López-Ferrer, Barcelona, Spain - Prof. Dr. Ulrich Mrowietz, Kiel, Germany Thursday 26th September at 17:45 (CEST) / Room G104-G105 (SAT 11.04). Satellite Symposium on atopic dermatitis : Precision in AD: how lebrikizumab is changing the treatment paradigm - Chair, Prof. Dr. Marjolein de Bruin-Weller, Utrecht, The Netherlands - Dr. Andrew Blauvelt, Lake Oswego, US - Prof. Dr. Sascha Gerdes, Kiel, Germany Friday 27th September at 13:00 (CEST) / Room G104-G105 (SAT 11.06). A total of 37 abstracts have been accepted by the EADV for their annual meeting. Ebglyss® (lebrikizumab ) 1. Late breaking news: Efficacy and safety of lebrikizumab is maintained up to 3 years in patients with moderate-to-severe atopic dermatitis: ADvocate 1 and ADvocate 2 to ADjoin long-term extension trial 2. Absolute EASI response achieved by lebrikizumab over 16 weeks in patients with moderate-to-severe atopic dermatitis 3. Absolute itch and quality of life response with lebrikizumab through 52 weeks 4. Absolute EASI response achieved with lebrikizumab over 52 weeks in patients with moderate-to-severe atopic dermatitis 5. Absolute response of lebrikizumab at Week 52 in patients with moderate-to-severe atopic dermatitis who did not achieve protocol-defined response after initial 16 weeks of treatment 6. Improvement across disease dimensions with lebrikizumab in combination with topical corticosteroids in atopic dermatitis inadequately controlled or ineligible to cyclosporine: results from the ADvantage study 7. Lebrikizumab improves signs and symptoms of moderate-to-severe atopic dermatitis in patients inadequately controlled or ineligible for cyclosporine: week 52 results of a phase 3 clinical study (ADvantage) 8. Lebrikizumab in monotherapy improves the signs of moderate-to-severe atopic dermatitis across different body regions including the head and neck over one year of treatment 9. Number needed to treat with lebrikizumab in monotherapy at Week 16 in patients with moderate-to-severe atopic dermatitis Ilumetri® (tildrakizumab) 1. Improving the well-being of patients with moderate to severe plaque psoriasis and involvement of impactful areas with Tildrakizumab 2. Effectiveness and Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA) of tildrakizumab patients with nail psoriasis: 52-week results from the phase IV POSITIVE Austrian subset. 3. Effectiveness of tildrakizumab in patients with moderate-to-severe psoriasis located in special areas: 52-week results from the POSITIVE study 4. High effectiveness of tildrakizumab in bio-naïve and bio-experienced patients with moderate-to-severe psoriasis: 52-week results from the POSITIVE study 5. High effectiveness of tildrakizumab regardless of baseline characteristics in patients with moderate-to-severe psoriasis: 52-week results from the POSITIVE study 6. Patient-reported well-being using tildrakizumab for psoriasis in a real-world setting: 52-week interim data of the phase IV POSITIVE study 7. Safety of tildrakizumab in patients with moderate-to-severe psoriasis: 52-week data from the phase IV POSITIVE study 8. Effectiveness of tildrakizumab for itch, pain, and fatigue in patients with moderate-to-severe psoriasis: 52-week results from the real-world POSITIVE study 9. Quality of life, work productivity and treatment satisfaction with tildrakizumab in moderate-to-severe psoriasis patients: 52-week interim data of the real-world POSITIVE study 10. Impact of patient psoriasis on partner well-being in a real-world setting: 52-week interim data of the phase IV POSITIVE study 11. Efficacy and safety of tildrakizumab through Week 28 in patients with early vs late-onset moderate-to-severe plaque psoriasis: A post hoc analysis of reSURFACE 1 and reSURFACE 2 Wynzora® (CAL/BDP) 1. Impact of calcipotriene and betamethasone dipropionate cream with PAD technology (CAL/BPD PAD cream) on scalp-PGA success, S-mPASI and clinician satisfaction among patients with mild-to-moderate scalp psoriasis in routine clinical practices in Europe. An interim analysis of the PRO-SCALP study. 2. Impact of calcipotriene and betamethasone dipropionate cream with PAD technology (CAL/BPD PAD cream) on patient symptoms, functioning, emotions, level of itching, and sleep quality among patients with mild-to-moderate scalp psoriasis in routine clinical practices in Europe. An interim analysis of the PRO-SCALP study. 3. Patient preference over other topicals, perception of cream usability, treatment adherence and satisfaction among patients with mild-to-moderate scalp psoriasis using calcipotriene and betamethasone dipropionate cream with PAD technology (CAL/BPD PAD cream) in routine clinical practices in Europe. An interim analysis of the PRO-SCALP study. 4. Best responders to calcipotriol and betamethasone dipropionate PAD-cream: post-hoc analysis from pooled MC2-01-C2 and MC2-01-C7 phase III trials at week 4 and week 8. 5. Cost per responder analysis of calcipotriol plus betamethasone dipropionate cutaneous PAD cream for the topical treatment of mild to moderate plaque psoriasis in Italy. 6. Patient benefit assessment of topical treatment in psoriasis: Validation of the PBI-TOP questionnaire in a longitudinal study. Klisyri® (tirbanibulin) and actinic keratosis 1. Lack of correlation between number of baseline actinic keratoses and local tolerability signs severity in patients treated with tirbanibulin over a 100 cm2 area: results from a Phase 3 study 2. Real-world evidence of tirbanibulin for actinic keratosis in Germany. Insights into patient-reported outcomes, safety and effectiveness 3. Efficacy and safety of tirbanibulin 1% ointment for the treatment of actinic keratosis in conditions close to routine clinical practice in Spain and Italy (TIRBASKIN study) 4. Patient and physician-reported outcomes with tirbanibulin 1% ointment for actinic keratosis in conditions close to routine clinical practice in Spain and Italy (TIRBASKIN study) 5. Enhancement of sun-damaged skin qualities with tirbanibulin (SunDamage Study) 6. Actinic cheilitis: Diagnosis and monitoring after treatment with Tirbanibulin using optical coherence tomography 7. Diagnosis and treatment of patients with actinic keratosis in France: REAKT study Actinic keratosis in France: an avoidable risk of skin cancer, unexpectedly also for people aged under 65 years (REAKT study) 8. Actinic keratosis in France: disease perceptions, expectations, and behaviors of patients (REAKT study). Poster availability date and time : From 25 September 2024 (07.00 CEST) until 3 months post congress. Location : https://eadv.org/congress/ , and e-poster area 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 2023: €898.8 MM, 1900 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.