Clinical R&D 81 MICHALA FISCHER-HANSEN TO JOIN THE BOARD OF ABACUS MEDICINE Abacus Medicine A/S is again strengthening its Board of Directors as Michala FischerHansen will join as a new member. She is nominated by the two main shareholders in Abacus Medicine, which are Wagner Family Holding and Chr. Augustinus Fabrikker. Michala Fischer-Hansen is currently Executive Vice President at Falck, where she is also a member of the Executive Management. “With Michala Fischer-Hansen’s international profile, a great understanding of our industry and her experience with commercial effectiveness, marketing, pharma economics and market access, she is the right profile to contribute to the Abacus Medicine Group’s continued growth,” says Flemming Wagner, CEO and founder of Abacus Medicine. Before joining Falck in 2019, Michala Fischer-Hansen had a 19-year commercial career at Novo Nordisk, i.a. as VP and General Manager for Novo Nordisk operations in Australia and New Zealand. Earlier, Michala also served as Corporate Vice President heading up the commercial global rollout of a new insulin portfolio of brands and Senior Director of Marketing Effectiveness at Novo Nordisk Inc. in the US. Michala Fischer-Hansen has previously served as Vice Chairman of the Board of the World Diabetes Foundation as well as previous elected member of the Board of Medicines Australia. Abacus Medicine A/S will invite all shareholders to an extraordinary general meeting as soon as possible. With the addition of Michala Fischer-Hansen, the Board of Directors of Abacus Medicine A/S will consist of Niels Smedegaard (Chairman), Anders K. Bønding, Michala Fischer-Hansen, Jens Albert Harsaae, Mark Johnston, Troels Peter Troelsen, and Flemming Wagner. ALZECURE'S ALZHEIMER'S PROJECT RECEIVES APPROVAL TO START NEXT CLINICAL PHASE I STUDY WITH ACD856 AlzeCure Pharma AB (publ) (FN STO: ALZCUR), a pharmaceutical company that develops a broad portfolio of candidate drugs for diseases affecting the central
nervous system, with projects in both Alzheimer's disease and pain, has announced that the company has received approval from the regulatory authorities in Sweden to begin the next clinical phase I study (multiple ascending dose, MAD) with the candidate drug ACD856 focused on Alzheimer's disease. The MAD Phase I study is AlzeCure's third clinical study with ACD856, the lead candidate drug within the company's NeuroRestore platform. ACD856 is being developed as a symptomrelieving treatment for disease states where the cognitive ability is impaired, such as in Alzheimer's disease. The primary study goal is to evaluate ACD856's tolerability and safety after repeated dosing, as well as to examine early signals on brain activity. The substances in the NeuroRestore platform stimulate several important signaling pathways in the brain, which, among other things, leads to improved cognition. Preclinical studies have shown that AlzeCure's candidate drugs strengthen the communication between nerve cells and improve cognitive ability including memory functions. "I'm very pleased that we have all regulatory approvals in place to be able to start the next study with ACD856. This means we will be able to start the MAD study during the fall, which is in line with our previously communicated goals," said Johan Sandin, CSO at AlzeCure Pharma. "This is a statement of strength that shows that AlzeCure continues to deliver according to plan," said Martin Jönsson, CEO of AlzeCure Pharma AB. "Diseases with cognitive disorders, and especially Alzheimer's disease, are areas with high need of new, more effective treatments and I am very much looking forward to the continued development of this important candidate drug." DUPIXENT® (DUPILUMAB) PIVOTAL TRIAL MEETS ALL PRIMARY AND SECONDARY ENDPOINTS A pivotal Phase 3 trial evaluating Dupixent® (dupilumab) for the treatment of children aged 6 months to 5 years with moderateto-severe atopic dermatitis, a chronic type 2 inflammatory disease, met its primary and all secondary endpoints. The data show adding Dupixent to standard of care topical corticosteroids (TCS) significantly reduced
overall disease severity and improved skin clearance, itch, and health-related quality of life measures at 16 weeks compared to TCS alone. Dupixent is the first biologic medicine to show positive results in this young population and remains the only approved biologic medicine in patients 6 years and older with uncontrolled moderate-to-severe atopic dermatitis. The data reinforce the wellestablished efficacy and safety profile of Dupixent in other age groups including a lower observed rate of skin infection in the Dupixent group compared with placebo. During the 16week treatment period Dupixent patients were 50% less likely to experience a skin infection (12% Dupixent, 24% placebo), and the total number of infections was nearly 70% lower (11 Dupixent, 34 placebo). These results add to the extensive LIBERTY AD clinical program – the largest Phase 3 clinical trial program in atopic dermatitis involving approximately 3,500 children, adolescents, and adults to date. Atopic dermatitis is a chronic type 2 inflammatory disease, with the age of onset younger than 5 years in 85-90% of patients. The debilitating symptoms that infants and young children with moderate-to-severe atopic dermatitis experience often continue through adulthood and include intense, persistent itch and skin lesions that can cover much of the body, resulting in skin dryness, cracking, redness or darkening, crusting and oozing – along with increased risk of skin infections. Moderate-to-severe atopic dermatitis significantly impacts the life of a young child, their parents and caregivers, including their mood, sleep patterns, and quality of life. In addition, the underlying type 2 inflammation involved in atopic dermatitis can contribute to the development of other atopic diseases, like asthma, that may also appear throughout a person's life. Patients received Dupixent every four weeks (200 mg or 300 mg, based on body weight) plus TCS or TCS alone (placebo). The primary endpoints assessed the proportion of patients achieving an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) and 75% improvement in Eczema Area and Severity Index (EASI-75). The prespecified primary analysis showed that at 16 weeks patients treated with Dupixent:
• 28% achieved clear or almostclear skin compared to 4% with placebo (p=<0.0001), the primary endpoint. • 53% achieved 75% or greater overall disease improvement from baseline compared to 11% with placebo (p=<0.0001), the co-primary endpoint outside of the U.S. • 70% average improvement from baseline in EASI compared to 20% improvement with placebo (p=<0.0001). • 49% average improvement from baseline in itch compared to 2% improvement in placebo (p<0.0001). • Significantly improved measures of observed patient outcomes (including sleep, skin pain and health-related quality of life), as well as caregiver-reported health-related quality of life. The trial demonstrated similar safety results to the known safety profile of Dupixent in atopic dermatitis. For the 16-week treatment period, overall rates of adverse events (AEs) were 64% for Dupixent and 74% for placebo. Most common AEs and AEs of special interest included nasopharyngitis (8% Dupixent, 9% placebo), upper respiratory tract infection (6% Dupixent, 8% placebo) and conjunctivitis (5% Dupixent, 0% placebo), herpes viral infections (6% Dupixent, 5% placebo) and injection site reactions (2% Dupixent, 3% placebo). ORION CORPORATION AND ALLIGATOR BIOSCIENCE ANNOUNCE IMMUNOONCOLOGY RESEARCH COLLABORATION AND LICENSE AGREEMENT Orion Corporation and Alligator Bioscience (Nasdaq Stockholm: ATORX) have announced that they have entered into a research collaboration and license agreement to discover and develop together new bispecific antibody cancer therapeutics. The research collaboration is focused on the discovery of novel bispecific antibodies directed towards immuno-oncology targets selected by Orion. The agreement covers an option to develop three bispecific antibodies. The agreement calls for Alligator Bioscience to employ its proprietary phage display libraries and RUBY™ bispecific platform to develop immuno-oncology product candidates based on design criteria identified by Orion. During the research period of the
HOSPITALPROFESSIONALNEWS.IE | HPN • OCTOBER - 2021
