Chuangxiang: izokibep HS clinical phase 2b/3 data released

Recently, a ring of biological (InmageneBiopharmaceuticals, hereinafter referred to as "the ring") announced that With partners Affibody company in Sweden and the United States ACELYRIN company to jointly develop IL - 17 a fusion protein antagonists izokibep (IMG - 020) in the treatment of moderately severe fester sex gland inflammation (hidradenitissuppurativa, HS) clinical phase 2 b / 3 research data in the United States Presented at the Academy of Dermatology (AAD) Annual Meeting. The trial was A pivotal Phase 2b/3 study evaluating the efficacy and safety of izokibep. It consisted of Part A (open-label trial) and Part B (randomized, double-blind, placebo-controlled study). In Part A, after 12 weeks of treatment with izokibep, the clinical response to HS (HiSCR) was significantly higher, with a 100% reduction in the total number of abscesses and inflammatory nodules (HiSCR100) in 33% of subjects, exceeding the previous therapeutic effect of other products. Part B is ongoing.

HS is an autoimmune disease characterized by inflammation and suppuration of exocrine glands, which can lead to skin abscess, pain, scar, odor, etc., seriously affecting patients' quality of life.

The study included 30 participants at nine centers in the United States who received 160 milligrams of izokibep subcutaneously each week. After 12 weeks of treatment, abscesses and inflammatory nodules were reduced by at least 50% (HiSCR50), 75% (HiSCR75), 90% (HiSCR90), and 100% (HiSCR100) in 71%, 57%, 38%, and 33%, respectively. No other drug has achieved such a high level of efficacy over this time frame.

The clinical safety data in this study were consistent with the safety profile of previous izokibep studies and the entire IL-17A antagonist class, with the most common adverse event being local mild to moderate injection site reactions (ISRs). Candida infections did not occur in this study, and there was no evidence of an increased risk of infection after treatment. Based on these positive results, HS's second global multicenter Phase 3 pivotal clinical trial will be accelerated.

Dr. Lu Yufang

Chief Medical Officer of Chuang Hsiang

"We are pleased to see that izokibep has demonstrated very good clinical effectiveness in treating moderate-to-severe HS patients. The HiSCR100 response rate reached 33% after 12 weeks of treatment, the best clinical outcome reported to date. "Combined with the clinical data available to date for the treatment of HS and psoriatic arthritis, we believe that izokibep has the potential to be best in class, and we look forward to the benefits of izokibep for patients."

About izokibep(IMG-020)

Izokibep is an innovative bi-specific fusion protein that effectively targets IL-17A and serum albumin. To date, izokibep has been used in numerous clinical trials for a variety of immunological indications, including HS, psoriatic arthritis (PsA), axial spinal arthritis (axSpA), and Uveitis. Nearly 500 patients have been treated with izokibep, most of whom have been on the drug for more than three years. In clinical trials, izokibep was well tolerated and its safety was consistent with that of the entire class of anti-IL-17A drugs.

Designed to overcome the limitations of antibody-class drugs, Izokibep has a molecular weight of about 1/8 that of ordinary antibodies and an apparent affinity for IL-17A approximately 1,000 times that of typical IL-17A antibodies. izokibep is injected subcutaneously to achieve the level of drug exposure that is required for normal antibody drugs to be injected intravenically, and its smaller molecular weight makes it more likely to reach target tissues that antibodies cannot. In addition, izokibep binds specifically to albumin in human body, so it has a half-life similar to antibody, and may be enriched with albumin in focal areas. izokibep is produced in the Escherichia coli system, and it is estimated that the production cost per dose of Izokibep should be significantly less than that of typical antibody drugs (typically produced in mammalian cell lines) at the mass production stage.

Chuang has introduced the commercialization rights of izokibep in Greater China and South Korea from the Maffibody, and is entitled to receive milestone payments and sales sharing in other regions in the world. Chuang Ring is actively cooperating with its partners, the Affibody and ACELYRIN, to promote the clinical development of five indications worldwide.