SAN DIEGO, SHANGHAI and SYDNEY, March 20, 2023 /PRNewswire/ -- Inmagene Biopharmaceuticals ("Inmagene") announced that the topline 12-week data from a Phase 2b/3 trial of izokibep in treating patients with moderate-to-severe Hidradenitis Suppurativa (HS) have been presented at the American Academy of Dermatology (AAD) Annual Meeting in New Orleans, USA. This trial has been conducted by Inmagene's partner ACELYRIN, INC.
The data from the open label Part A of the trial demonstrated that izokibep treatment led to higher orders of Hidradenitis Suppurativa Clinical Response (HiSCR), including unprecedented HiSCR100 response at 12 weeks. The double-blind, placebo-controlled Part B of this trial is ongoing and, based on the positive results, a second Phase 3 pivotal clinical trial in HS will be accelerated.
In the trial conducted across nine sites in the United States, 30 participants received 160 mg of izokibep dosed subcutaneously every week. The participant demographics were highly consistent with historical studies in the disease and included Hurley Stage II and III patients. At 12 weeks, 71% of participants achieved HiSCR50, 57% achieved HiSCR75, 38% achieved HiSCR90 and 33% achieved HiSCR100 – a response not previously reported for any agent in this treatment period.
The safety profile was consistent with previous izokibep studies, with localized mild-to-moderate injection site reactions (ISRs) being the most common adverse event. There was no evidence of increased risk of infection and there were no candida events reported through week 12.
"The high order HiSCR responses seen as early as 12 weeks, including 33% patients achieving HiSCR100, are unparalleled in moderate-to-severe HS patients compared to historical studies," said Dr. Yufang Lu, Chief Medical Officer of Inmagene, "We believe that data from this study and the previously reported studies have demonstrated izokibep's potential to deliver differentiated clinical benefits for patients."
The data was presented by Kim A. Papp, MD, FAAD, in a Late-Breaking plenary session at the AAD Annual Meeting on March 18, 2023. The title of the presentation is: "Izokibep, a Novel IL-17A Inhibitor, Demonstrates HiSCR100 Responses in Moderate-to-Severe Hidradenitis Suppurativa: Open-Label Part A Results of a Phase 2b/3 Study".
Inmagene has exclusive development and commercialization rights for izokibep in the Greater China (including Mainland China, Hong Kong, Macau, and Taiwan) and Korea, and is eligible to receive milestone-based payments and royalties in other regions of the world from Inmagene's partner Affibody AB.
About Izokibep
Izokibep has been administered to more than 400, 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 Hidradenitis Suppurativa (HS)
HS is a chronic Inflammatory skin disease causing scarring, abscesses, malodor and pain. HS typically occurs in areas with high concentrations of sweat glands and is typically accompanied by pain, malodor, drainage, and disfigurement that contribute to disability and a devastating impact on quality of life. Patients with HS miss a greater number of days of work and have increased disability compared to the average population.
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 2 studies for both psoriasis and psoriatic arthritis (PsA). It has received the IND approval from China's Center for Drug Evaluation (CDE) for Phase 3 studies in plaque psoriasis. In addition, IMG-007, a monoclonal antibody (mAb) against OX40 with a silenced antibody-dependent cell-mediated cytotoxicity (ADCC) function, is entering two global Phase 2 clinical trials. IMG-004, a non-covalent reversible Bruton's tyrosine kinase (BTK) inhibitor with a potent target engagement and an extended half-life, is in Phase 1 development. Moreover, IMG-008, a long-acting mAb against IL-36 receptor (IL-36R), has been cleared by the FDA via an IND-application for Phase 1 clinical development.
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® 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.