SAN DIEGO, SHANGHAI and SYDNEY, Feb. 6, 2023 /PRNewswire/ -- Inmagene Biopharmaceuticals ("Inmagene") announced that the U.S. Food and Drug Administration (FDA) recently granted the initial investigational new drug (IND) application for its drug candidate IMG-008, a long-acting anti-IL-36R antibody with enhanced half-life and exposure.
IMG-008, a humanized monoclonal antibody (mAb) that specifically targets human interleukin 36 receptor (IL-36R), potently blocks the IL-36 signaling and reduces cytokine releases and inflammatory responses. In a pre-clinical study in monkeys, IMG-008 has demonstrated over 4 times longer half-life and over 2 times higher exposure than spesolimab analog. IMG-008 may potentially provide a treatment option for multiple inflammatory diseases, such as generalized pustular psoriasis (GPP) and hidradenitis suppurativa (HS). Patients with the target diseases often suffer from high levels of inflammation, repeated flares, and comorbidities associated with obesity.
The proposed IND-opening study is a randomized, double-blind, placebo-controlled dose escalation Phase I study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of IMG-008 in healthy adult subjects. IMG-008's extended half-life and enhanced exposure have been designed to potentially increase the efficacy, and reduce the dosing frequency and dose levels, which would be beneficial for not only the acute phase treatment but also the prevention or maintenance phase.
Yuntao Wan, Inmagene's Chief Development Officer, said, "IMG-008 has been created from Inmagene's proprietary QuadraTek drug discovery platform, which demonstrates our superb innovation capabilities. We continue to grow our strong clinical portfolio with innovative drug candidates like IMG-008."
IMG-008 is a novel long-acting antagonistic monoclonal antibody targeting IL-36R. Generated from Inmagene's proprietary QuadraTek drug discovery platform, it is being developed to potentially treat auto-inflammatory diseases. IL-36 cytokines belong to the IL-1 family and play an important role in regulating the innate immune system, and their uncontrolled activation and expression results in pathologic inflammatory responses. Pre-clinical studies have shown that IMG-008 has high binding affinity to IL-36R and has potent in vitro activity to block IL-36R downstream signaling and cytokine release. Compared to spesolimab analog, IMG-008 has demonstrated better in vivo efficacy in certain animal models, as well as longer half-life and higher exposure in monkeys. Spesolimab has been approved for GPP flare recently.
Inmagene is a global biotechnology company focused on developing novel therapeutics for immunology-related diseases. It has four clinical-stage drug candidates. The leading compound is izokibep (IMG-020), which is in two global Phase 2b/3 trials for PsA and HS. It has received the IND approval for a phase III pivotal study in plaque psoriasis from China's Center for Drug Evaluation (CDE). In addition, IMG-004 and IMG-007 are completing global phase I studies and IMG-008 is entering Phase I.
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.
This press release contains forward-looking statements. While Inmagene believes 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.