Affibody and Inmagene announce IND Clearance for izokibep (ABY-035) for the treatment of Non-infectious Non-anterior Uveitis
- Category: Proteins and Peptides
- Published on Tuesday, 09 March 2021 13:14
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Partners will continue to file INDs in additional applications in autoimmune diseases during 2021
SAN DIEGO, CA, USA; SHANGHAI, China, and SOLNA, Sweden I March 9, 2021 I Affibody AB (“Affibody”) and Inmagene Biopharmaceuticals (“Inmagene”) today announced that the U.S. FDA has cleared the novel interleukin-17 (IL-17) blocker izokibep (ABY-035) to proceed to Phase 2 clinical development in non-infectious intermediate, posterior, and pan-uveitis (“Uveitis”), an orphan disease with significant unmet medical need. The partners are jointly developing izokibep to treat multiple autoimmune diseases, and Affibody has taken the responsibility to manage the global clinical trials for Uveitis.
“Uveitis is one of the leading causes of blindness worldwide. Through the years, we have learned much about the role of IL-17 in the pathogenesis of non-infectious uveitis; thus, we are very excited about the LINNAEA study to investigate a novel mechanism of blocking IL-17” said Quan Dong Nguyen, MD, MSc, FARVO, Principal Coordinating Investigator of the LINNAEA Study, and Professor of Ophthalmology at the Byers Eye Institute, Stanford University School of Medicine, USA. “We have designed the study to evaluate the role of izokibep as a first-line therapeutic option for active non-infectious uveitis as well as a steroid-sparing immunomodulatory agent.”
The study is a one-year phase 2 trial in approximately 110 patients with active Uveitis. The trial will evaluate the efficacy, safety and tolerability of izokibep as compared to standard of care.
“The LINNAEA Study in uveitis patients is an example of a modern trial design that has been developed in close collaboration with leading ophthalmologists”, commented David Bejker, CEO of Affibody. “It also represents our commitment to bring potential best-in-class first-in-indication medicines to patients with seriously debilitating diseases.”
Inmagene and Affibody expect to file IND applications for izokibep in additional autoimmune diseases during 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 uveitis and axial spondyloarthritis.
About the Phase 2 trial (LINNAEA Study)
The LINNAEA study is a phase 2 trial of the efficacy and safety of the interleukin-17A inhibitor ABY-035 in the treatment and prevention of relapse/recurrence of non-infectious intermediate, posterior or pan-uveitis, which includes an initial pilot phase. The study will include 110 patients be conducted across approximately 50 trial sites in Europe and North America. The study consists of two parts (Part A and Part B). The primary objective of Part A is to evaluate the efficacy of ABY-035 in treating active uveitis from Baseline (BL) up to week 10 and the primary objective of Part B is to investigate the efficacy of ABY-035 in preventing relapse/recurrence in inactive uveitis from trial beyond week 10 up to week 50. All patients are subject to protocol defined steroid tapering.
Uveitis is an inflammation of the uveal tract (iris, ciliary body, & choroid), but can also include the inflammation of nearby tissues, such as the retina, the optic nerve, & the vitreous humor. Uveitis can be classified according to: (a.) the anatomical parts of the eye involved in anterior and non-anterior (intermediate, posterior and panuveitis), and (b.) the underlying etiological cause into infectious and non-infectious (either idiopathic or associated with systemic immune-mediated disease, such as Behçet’s disease and Vogt-Koyanagi-Harada disease, IBD etc.).
Idiopathic uveitis is often related to autoimmune and autoinflammatory causes, such as cell-mediated mechanism in which autoreactive T cells recognize self-antigen within the retinal tissue and lead to tissue damage by direct infiltration and production of cytokines, amplifying the immune response and the innate immune system.