Affibody and Inmagene announce IND Clearance for Izokibep (ABY-035) for the treatment of Ankylosing Spondylitis
- Category: Proteins and Peptides
- Published on Wednesday, 10 February 2021 12:49
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Partners eye additional applications in autoimmune diseases during 2021
SAN DIEGO, CA, USA; SHANGHAI, China, and SOLNA, Sweden I February 10, 2021 I Affibody AB (“Affibody”) and Inmagene Biopharmaceuticals (“Inmagene”) today announced that the U.S. FDA has cleared izokibep (ABY-035) to proceed to Phase 2 clinical development in Ankylosing Spondylitis (AS), a subset of Axial Spondyloarthritis (axSpA). The partners are jointly developing izokibep to treat multiple autoimmune diseases, and Inmagene has taken the responsibility to manage the global clinical trials for axSpA.
“Obtaining FDA IND clearance 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 life quality for AS patients.”
The study is a one-year double-blind controlled trial in approximately 300 patients with active Ankylosing Spondylitis. The trial will evaluate the efficacy, safety and tolerability of three different dosage regimens of izokibep as compared to placebo.
“We believe that izokibep is well positioned to improve the life of patients with AS with its high potency and strong safety profile”, commented Fredrik Frejd, CSO of Affibody. “In addition, the IL-17 biology offers ample scope for further development and commercialization. We look forward to exploring the drug’s use to address multiple indications.”
Today’s announcement follows the 2020 initiation of a Phase 2 Psoriatic Arthritis study with izokibep (ABY-035). Inmagene and Affibody expect to file IND applications for izokibep in additional autoimmune diseases during the first part of 2021.
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
Inmagene, with wholly owned subsidiaries in San Diego, Shanghai, and Hangzhou, is a leading biotech company focused on immunology-related therapeutic areas. Believing in borderless medicine, the Inmagene team strives to integrate the most efficient resources in the U.S. and Asia to develop drug candidates with first-in-class or best-in-class potentials for worldwide patients. It also in-licenses products for the Asia markets and, together with its partners, carries out worldwide development activities, including global multi-center clinical trials.
Inmagene is building a strong pipeline with over 10 drug candidates for immunological diseases. Izokibep, Inmagene’s most advanced drug candidate, is in global clinical trials for multiple indications. The company has formed strategic partnerships with Chi-Med (Nasdaq/AIM: HCM) and Affibody AB to develop and commercialize highly innovative drug candidates.
Further information can be found at: www.inmagenebio.com
About izokibep (ABY-035 or IMG-020)
Izokibep is a novel bispecific agent, potently targeting both subunits of IL-17A as well as albumin. Izokibep has been specifically designed to utilize the strengths of Affibody’s technology platform to create a very small protein drug (18 kDa, an eighth 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 previous and ongoing clinical trials in patients with plaque psoriasis and psoriatic arthritis support the continued development of izokibep in several indications, including axSpA.
About the Phase 2 trial
The study is a one year multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of izokibep in subjects with active AS. Three dosage regimens of izokibep will be evaluated and compared to placebo. The primary endpoint will be Assessment of Spondyloarthritis International Society 40 (ASAS40) response at Week 16. The study will be conducted in several countries, including the U.S. and China. Approximately 300 patients are planned to be randomized (75 per treatment group).
About Spondyloarthritis and Axial Spondyloarthritis
Spondyloarthritis (SpA) is a blanket term applied to a family of inflammatory rheumatic diseases that cause arthritis. Common features of SpA include inflammation in the spine, pelvis, other joints, intestine, eyes, and heels. Diseases that fall under the SpA umbrella include axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), reactive arthritis, the arthritis of inflammatory bowel disease (IBD), and undifferentiated spondyloarthritis. SpA is distinct from other inflammatory arthritides, particularly rheumatoid arthritis (RA) as it involves the sites where ligaments and tendons attach to bones called entheses.
axSpA is an immune-mediated rheumatic disease that primarily affects the spine and sacroiliac joints, leading to back pain and stiffness. There are two subgroups of axSpA that can be considered as two consecutive stages of one disease, and they differ in terms of disability and pain present. The two subgroups are nonradiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS). AS is a more severe and advanced form of axSpA in which individuals show radiologic changes that can be detected by X-ray imaging. According to Datamonitor, there were 5.9 million cases of AS in adults aged 20 years and older worldwide in 2018.