ICP-488

BEIJING, China I October 09, 2024 I InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that phase II clinical study results of novel TYK2 (Tyrosine Kinase 2) inhibitor ICP-488 met the primary endpoint in adult patients with moderate-to-severe plaque psoriasis. ICP-488, in psoriasis patients treated for 12 weeks, demonstrated an excellent efficacy and safety profile. ICP-488 achieved multiple efficacy endpoints including Psoriasis Area and Severity Index (PASI) 75, PASI 90, PASI 100 (improvement of at least 75%, 90% and 100% in PASI score from baseline) and static Physician’s Global Assessment (sPGA) 0/1 (score of 0 ‘clear’ or 1 ‘almost clear’) in both the 6mg and 8mg dosing group respectively. Following the 12-week treatment with 6mg or 9mg once-daily dosing of ICP-488, PASI 75 reached 77.3% and 78.6% respectively, compared to 11.6% for patients receiving placebo (p<0.0001); PASI 90 reached 36.4% and 50.0% respectively, compared to 0% for patients receiving placebo (p<0.0001); PASI 100 reached 11.4% and 11.9% respectively, compared to 0% for patients receiving placebo (p<0.05); sPGA 0/1 reached 70.5% and 71.4% respectively, compared to 9.3% for patients receiving placebo (p<0.0001). ICP-488 demonstrated good tolerability and a favorable safety profile, with most treatment emergent adverse events (TEREs) and treatment-related adverse events (TRAEs) being mild or moderate. Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, ” Psoriasis requires long-term management, and there remains a significant unmet medical need for new treatments. We are excited to see the positive results from the phase II study of ICP-488, and we will further accelerate its clinical development to benefit patients with psoriasis and other autoimmune diseases.” This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study aimed at evaluating the efficacy, safety, PK and PD characteristics of ICP-488 in Chinese adult patients with moderate to severe plaque psoriasis. A total of 129 patients were enrolled in this study. Patients were randomly assigned to one of three treatment groups in a 1:1:1 ratio, a 6mg once-daily group, a 9mg once-daily group, and a placebo group, for 12 consecutive weeks of treatment. ICP-488 is an oral, potent and selective TYK2 allosteric inhibitor. By binding to the JH2 domain, ICP-488 blocks the signal transduction of IL-23, IL-12, type 1 IFN and other inflammatory cytokine, thereby inhibiting the pathological process of autoimmune and inflammatory diseases. Recent data indicates that approximately seven million people in China are currently living with psoriasis 1 , and this number is on the rise 2 . Existing treatment options do not fully address the needs of those affected by this condition, highlighting a significant gap in available therapies. There is a particularly acute demand for new, oral medications. Many patients, especially those with moderate-to-severe psoriasis, continue to be persistently undertreated or remain untreated altogether 3 . About InnoCare InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States. SOURCE: InnoCare

Plus, news about Inhibikase, Bio-Thera, Richter, InnoCare and Scholar Rock: Crinetics prices $500M offering: The San Diego biotech upsized the offering by $100 million from $400 million . The biotech last month asked the FDA to approve its oral acromegaly drug, called paltusotine. — Kyle LaHucik Boehringer Ingelheim teams up with Circle Pharma: The German drugmaker will pay up to $607 million in a pact with the macrocycles biotech , which unveiled a $90 million Series D last month. The duo plans to work on a cyclin inhibitor to prevent cancer cells from growing. — Kyle LaHucik Inhibikase’s $110M PIPE: The Boston and Atlanta biotech will use the money to fund a Phase 2b in pulmonary arterial hypertension, a condition that recently received a new FDA-approved treatment from Merck. — Kyle LaHucik Bio-Thera, Richter partner on a biosimilar to Stelara: As part of the commercialization and licensing agreement , Bio-Thera will develop, manufacture and supply the copycat drug, while Richter will have exclusive rights to commercialize it in Europe, the UK and Switzerland. Bio-Thera will receive an upfront payment of $8.5 million, as well as potential development and commercial milestones up to $101.5 million. — Katherine Lewin InnoCare’s Phase 2 study hits primary endpoint in psoriasis: The tyrosine kinase 2 inhibitor, dubbed ICP-488, showed “excellent” efficacy and safety, according to the company, with 78.6% of patients in China seeing at least a 75% improvement in their plaque psoriasis on the highest dose over a 12-week treatment period. InnoCare CEO Jasmine Cui said the Beijing-based company plans to “further accelerate” development of ICP-488. — Katherine Lewin Scholar Rock upsized its public offering. It now aims to raise $300 million. — Jaimy Lee