San Diego, U.S., Shanghai, China, and Solna, Sweden, August 25, 2021. Inmagene Biopharmaceuticals (“Inmagene”), a leading biotech company focused on the development of therapeutics for immunology-related diseases, and Affibody AB (“Affibody”), a company developing innovative bi- and multi-specific next generation biopharmaceuticals, today announced dosing of the first patient in the global ASPIRE Phase 2 trial evaluating izokibep (IMG-020 or ABY-035) for the treatment of Ankylosing Spondylitis (AS).
“Dosing the first patient in the global Phase 2 AS trial is an important milestone for the izokibep program,” said Dr. Jean-Louis Saillot, Inmagene’s Chief Development Officer. “Working closely with our partner Affibody, the Inmagene team is excited to develop a potentially best-in-class treatment to improve the condition and quality of life of AS patients globally.”
“The ASPIRE study is an important trial to investigate the efficacy of izokibep for AS patients, leveraging the strong safety data from our prior studies”, commented Fredrik Frejd, CSO of Affibody. “We expect that both Affibody and Inmagene will be able to use the information from this study to advance the program in additional IL-17 driven indications.”
ASPIRE is a global Phase 2, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety and tolerability of izokibep for the treatment of patients with active ankylosing spondylitis (NCT04795141). Inmagene is responsible for all key development activities for the ASPIRE trial, including protocol design, study implementation and oversight. Inmagene has received IND approval/clearance in the US, Mainland China, South Korea, and Taiwan for the ASPIRE trial.
About izokibep (ABY-035 or IMG-020)
Izokibep is a novel bispecific agent, potently targeting both subunits of the IL-17A homo-dimer and serum albumin. It has been specifically designed to utilize the strengths of Affibody’s technology platform to create a very small protein drug (18 kDa, approximately 1/8 of the size of an antibody) with very high apparent affinity to IL-17A (KD ~300fM) and antibody-like half-life due to the strong (KD ~50pM) binding affinity to serum albumin.
Accumulated patient data from ~150 psoriasis patients, some of which have been dosed for more than two years, support a safe and efficacious product profile with best-in-class potential.
About Ankylosing Spondylitis (AS)
Ankylosing spondylitis is a common type of chronic inflammatory disease which leads to arthritis of the spine. It affects the pelvic joints and the spine. If not treated effectively, years of inflammation can lead to irreversible spinal injuries that lead to lifelong pain and disability with serious negative impact on the patient’s daily life. About 80% of AS patients will develop symptoms by the age of 30. If untreated, up to 70% of patients who develop severe AS will develop a terrible spine-joint fusion within 10 to 15 years, with a very high rate of disability.
Globally, the prevalence of AS is about 0.5%-1%, and most of them are male. Data show that about 80% of AS patients have spinal pain and fatigue symptoms, and up to 90% have morning stiffness.
About Inmagene
Inmagene, with wholly owned subsidiaries in San Diego, Shanghai, Hangzhou and Wuhan, is a leading biotech company focused on immunology-related therapeutic areas. Believing in “borderless innovation”, the Inmagene team integrates efficient resources worldwide to develop drugs for patients globally.
The company is building a robust pipeline of nearly 20 drug candidates. IMG-016, Inmagene’s most advanced drug candidate, is planned to submit NDA in 2022. Another drug candidate, Izokibep (IMG-020) has entered global phase 2 trials for multiple indications.
Inmagene has formed strategic partnerships with Affibody AB, HUTCHMED (Nasdaq/AIM: HCM), TWIB and Kissei to develop and commercialize highly innovative drug candidates. Inmagene is operating 12 “Smart Innovation” programs to create and develop novel drug candidates for the global market. It also in-licenses products for the Asia markets and, together with its partners, carries out global development activities, including multi-center clinical trials.
For additional information, please visit www.inmagenebio.com.
About Affibody
Affibody is a clinical stage biopharmaceutical company with a broad product pipeline focused on developing innovative bi- and multi-specific next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody® molecules and Albumod™.
The company operates a focused experimental medicine model and currently has two clinical stage programs. The first is izokibep that targets autoimmune diseases. The second program is a diagnostic imaging program that is directed primarily towards metastatic breast cancer.
Affibody AB is a holding of Patricia Industries.
Further information can be found at: www.affibody.com
Disclaimer
This press release contains forward-looking statements. While Inmagene and Affibody consider the projections to be based on reasonable assumptions, these forward-looking statements may be called into question by a number of hazards and uncertainties, so that actual results may differ materially from those anticipated in such forward-looking statements.