• Izokibep achieves higher orders of Hidradenitis Suppurativa Clinical Responses (HiSCR) in open label part of a Phase 2b/3 trial.
• Safety results consistent with previous trials of izokibep and the IL-17Ai class, with no increased risk of infection, including candida.
San Diego, Shanghai, January 6, 2023 – Inmagene Biopharmaceuticals (“Inmagene”)’s partner ACELYRIN, Inc. today announced top-line 12-week open label data from a Phase 2b/3 trial of izokibep in patients with moderate-to-severe Hidradenitis Suppurativa (HS). HS is an autoimmune disease characterized by inflammation of the exocrine glands and leading to skin abscesses, pain, scarring, malodor, and a devasting impact on the patient’s quality of life.
The 30-patient open label Part A of the Phase 2b/3 trial (NCT05355805) evaluated clinical response and safety of izokibep administered to patients with moderate-to-severe HS via subcutaneous injection. Izokibep demonstrated higher orders of Hidradenitis Suppurativa Clinical Responses (HiSCR), where low-to-no placebo responses have been reported historically. The safety data reported were consistent with previous trials of izokibep as well as the IL-17Ai class. Notably, there was no evidence of increased risk of infection and no candida infections were reported in this trial.
Inmagene has exclusive development and commercialization rights for izokibep in China (Mainland China, Hong Kong, Macau, Taiwan) and Korea, and will receive milestone payments and sales commissions from partners in other regions of the world.
“We are pleased to see that izokibep has further demonstrated good efficacy and drug safety in the extremely difficult-to-treat HS, following the best-in-class data achieved in the psoriatic arthritis study last year.” Mr. Wan Yuntao, Chief Development Officer of Inamgene, said, “Based on a unique molecular design, izokibep has high potency, a small size, and high tissue penetration. We believe that izokibep will enhance patient quality of life, improve challenging clinical conditions, and advance clinical practice in a wide range of immune-related diseases. ”
The full data from Part A of this trial will be presented at a future scientific meeting. The double-blind, placebo-controlled Part B of this Phase 2b/3 trial is ongoing, and based on the positive results of the Part A trial, Part B will advance at full speed, while a second global multicenter Phase 3 pivotal clinical trial of HS will be accelerated.
About Izokibep
Izokibep has been administered to over 300 patients, some for up to three years. It is a small therapeutic protein inhibitor of interleukin-17A (IL-17A) designed to overcome the limitations of monoclonal antibodies. With high potency and small molecular size – about one tenth the size of a traditional monoclonal antibody – izokibep can reach high drug exposure levels through a single, subcutaneous injection that monoclonal antibodies otherwise require IV administration to achieve. We have hypothesized that these characteristics could lead to clinically meaningful and differentiated impact in multiple diseases.
About Inmagene
Inmagene is a global clinical-stage biotechnology company focused on developing novel therapeutics for immunology-related diseases.
Inmagene’s most advanced drug candidate is IMG-020 (izokibep), which has successfully met the protocol endpoints in global phase II studies for both psoriasis and psoriatic arthritis (PsA). It has received the IND approval from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for phase III studies in plaque psoriasis. Inmagene is working with its partners to conduct global phase II studies for multiple autoimmune diseases. In addition, IMG-004 and IMG-007, both of which with global rights, are completing global phase I studies. IMG-008, an internally discovered drug candidate, has been submitted for Phase 1 IND.
Believing in “Borderless Innovation”, the Inmagene team strives to integrate efficient resources worldwide to develop novel therapeutics for global patients. Based on its proprietary QuadraTek® drug discovery platform, Inmagene creates and develops several novel drug candidates with global rights. Inmagene also in-licenses drug candidates and, together with its partners, carries out global development activities, including global multi-center clinical trials. Inmagene has formed strategic partnerships with multiple partners, such as HUTCHMED and Affibody AB, to develop highly innovative drug candidates. For more information, please visit: www.inmagenebio.com
Forward-Looking Statements
This press release may contain forward-looking statements, including statements regarding the ability to offer treatments with clinically meaningful, differentiated benefits, the safety and tolerability profile of izokibep, the ability to accelerate development of izokibep in HS, the ability to complete a second confirmatory trial of izokibep in HS, the potential for izokibep to be better than intravenous monoclonal antibodies, and the ability to execute on the goal of acquiring and accelerating development of product candidates. While Inmagene. considers any projections to be based on reasonable assumptions, these forward-looking statements may be called into question by numerous hazards and uncertainties, and actual results may differ materially from those anticipated in such forward-looking statements.