Solna, Sweden, November 8, 2022. Affibody today announced that positive additional data from a phase 2 trial of izokibep in psoriatic arthritis will be presented at the ACR Convergence 2022, November 10-14, 2022, Philadelphia, USA.
• Izokibep Phase 2 PsA Oral presentation to take place on November 13, 2022, in a session at 3:00PM-4:30PM (EST) / 21:00-22:30 (CET).
• Statistically significant and clinically important improvements across multiple measures of disease activity including DAS28-CRP, DAPSA and MDA.
• Improvements across health-related quality of life and physical functions, as measured by the Psoriatic Arthritis Impact of Disease Questionnaire, its sub-domains, as well as the SF-36 and the Health Assessment Questionnaire.
Izokibep is a unique interleukin-17A inhibitor designed to overcome the limitations of monoclonal antibodies by utilizing high potency and small molecular size to enable high drug exposure levels through a single, subcutaneous injection that monoclonal antibodies require intravenous (IV) administration to achieve.
“The data presented at ACR further expands upon the strong data set shared during EULAR, collectively demonstrating izokibep’s top-end efficacy in joints and skin as well as on difficult-to-treat endpoints such as enthesitis. This leads to minimizing the overall disease burden as well as improving the quality of life for patients which is our ultimate goal,” said David Bejker, CEO of Affibody. “These results are not only an outcome of fully utilizing our unique and proprietary technology platform to strategically identify indications and targets where we can create differentiated products that significantly improve the life of patients. It is also a testament to Affibody’s capability to design and execute clinical studies that demonstrate these advantages and bodes well for the future development of our company."
The data that will be presented at ACR Convergence 2022 show top of the range improvements in all key manifestations of PsA, including arthritis, psoriasis, dactylitis, and nail psoriasis. This adds to the evidence of differentiated efficacy in enthesitis previously reported in June this year at the 2022 European Alliance of Associations for Rheumatology (EULAR) Congress. The clinical improvements in these hard-to-treat disease manifestations, along with consistent, clinically important, and statistically significant disease activity improvements as measured by ACR50, PASI75, DAS-28, Minimal Disease Activity, DAPSA, predictably led to important improvements in patient-reported Quality of life (QoL) as measured by the SF-36, HAQ-DI, and the PsA-specific validated instrument, the PsAID. The improvements were found across all domains, including pain, sleep disturbance, physical function, and coping.
The patients with the largest improvements in clinical outcome measures had the largest gains in health-related quality of life, including improvements in each of the individual sub-scales of the PsAID.
Data to be presented at ACR Convergence 2022
“Achievement of Different Treatment Targets with Izokibep Demonstrates Efficacy Benefits in Patients with Active Psoriatic Arthritis: Results from a 16-Week Randomized, Placebo-Controlled Phase 2 Clinical Trial” to be presented by Frank Behrens, M.D., director of the Center of Innovative Diagnostics and Therapeutics Rheumatology/Immunology at the Goethe University in Frankfurt, Germany and a founding member of the Group of Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) on November 13, 2022.
For more information on this study and poster presentation, please visit the ACR Convergence 2022 website here and reference Abstract 1597.
“Izokibep, a Novel IL-17A Inhibitor, Improves Patient-reported Outcomes – 16 Week Results from a Placebo-controlled Phase 2 Study in Patients with Active Psoriatic Arthritis” – this presentation has been recorded and posted to the ACR website by Peter Taylor, M.D., Ph.D., FRCP, Norman Collison Professor of Musculoskeletal Sciences at the University of Oxford and Director of Clinical Sciences at the Botnar Research Centre within the Nuffield Department of Orthopedics, Rheumatology and Musculoskeletal Sciences and chairs the NOCRI Translational Research Partnership. This presentation is part of the selected “Ignite” posters and will be on tour November 12, 2022.
For more information on this study and poster presentation, please visit the ACR Convergence 2022 website here and reference Abstract 0199.
“Izokibep Demonstrates Clinically Relevant Efficacy Benefits on Enthesitis, Dactylitis and Nail Outcomes in Active PsA Patients: A 16-Week Randomized, Placebo-controlled Trial” – this presentation has been recorded and posted to the ACR website by Kurt de Vlam, M.D., Ph.D., Professor, Division of Rheumatology, University Hospitals Leuven, Belgium. This presentation is part of the selected “Ignite” posters and will be on tour November 14, 2022.
For more information on this study and poster presentation, please visit the ACR Convergence 2022 website here and reference Abstract 2151.
Enthesitis KOL Event
In addition, Affibody’s partner ACELYRIN, Inc., is hosting an affiliate event, “Enthesitis: The Patient Journey in PsA and AxSpA,” which is bringing world-leading rheumatologists and patients together to discuss the debilitating effects of enthesitis. This event will highlight the patient need for better treatment options to reduce the suffering associated with psoriatic arthritis and axial spondylarthritis. A replay will be available on their website at www.acelyrin.com following the close of the ACR Convergence 2022 meeting.
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a chronic, immune-mediated inflammatory musculoskeletal condition affecting the peripheral joints, the skin (with psoriasis), the nails, and in approximately 30 percent of individuals, the spine. Left under-treated, PsA leads to chronic joint pain, swelling, and damage with a high potential for permanent disability. Psoriatic arthritis pathology is dominated by pro-inflammatory T-helper (Th-17) cells that lead to over expression of IL-17, IL-23, and TNF cytokines.
To date, more than 300 patients – many for up to three years – have received izokibep, a small therapeutic protein inhibitor of interleukin-17A designed to overcome the limitations of monoclonal antibodies. With high potency and small molecular size, izokibep can reach high drug exposure levels through a single, subcutaneous injection that monoclonal antibodies require IV administration to achieve. The small size of izokibep – about one tenth the size of a monoclonal antibody – enables its potential to reach targeted tissues that may otherwise be inaccessible to the much larger monoclonal antibodies.
Izokibep is partnered with Inmagene Biopharmaceuticals Co. Ltd. and ACELYRIN Inc. Affibody has retained the marketing rights for the Nordic countries.
This press release contains forward-looking statements. While Affibody AB consider the projections to be based on reasonable assumptions, these forward-looking statements may be called into question by several hazards and uncertainties, so that actual results may differ materially from those anticipated in such forward-looking statements.