TAICANG, China, April 24, 2018 /PRNewswire/ -- Connect Biopharmaceuticals, Ltd. today announced that it has submitted an application in Australia to begin a phase 1 clinical trial to evaluate CBP-201, the company's monoclonal antibody candidate for allergic inflammation.
The planned phase 1 clinical trial is a randomized, double-blind, placebo-controlled study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CBP-201. At least 40 healthy subjects will be enrolled in this single ascending dose study.
"We are very excited to begin the process of initiating our first-in-man study of CBP-201, a novel and highly potent monoclonal antibody against interleukin-4 receptor alpha (IL-4R?). IL-4R? is a clinically-validated target known to mediate the biological activities of both IL-4 and IL-13, two key cytokines driving a broad array of allergic inflammatory diseases," said Jeffery White, MD, Chief Medical Officer of Connect Biopharmaceuticals. "Preclinical studies showed that CBP-201 had superior potency and pharmacokinetic properties compared to existing IL-4R? antibodies currently in clinical development. Using well-validated biomarkers, we expect this phase 1 study to provide important safety, PK, and PD data with CBP-201 to support further clinical development in patients."
"We are extremely pleased that Connect has once again advanced a high-quality, internally-discovered drug candidate into clinical studies," said Dr. Zheng Wei, CEO of Connect. "The progress of CBP-201 further validated our efficient operational strategy, which combines our strong expertise in T-cell modulation with efficient collaborations with top-quality CROs to deliver new therapeutics for inflammatory diseases with high unmet need both in China and globally."
About Connect Biopharmaceuticals
Connect Biopharmaceuticals is a China-based global clinical-stage company focused on discovery and development of novel immune modulators for the treatment of autoimmune diseases and inflammation. Our drug discovery technology platform is built on the biology of T cell functions, which identifies molecules that target clinically-validated disease pathways.
Our lead drug candidate is CBP-307, an orally-active, next-generation S1P1 and S1P5 (a G-protein coupled receptor -GPCR) modulator for the treatment of a range of autoimmune disorders, including inflammatory bowel disease, psoriasis, multiple sclerosis and other autoimmune diseases. We have completed a phase 1b randomized, double-blind, placebo-controlled study that assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of CBP-307. In this study, CBP-307 exhibited an excellent safety profile and potent T cell modulation activity as well as optimal pharmacokinetic and pharmacodynamic profiles, demonstrating best-in-class potential. CBP-307 is entering phase 2 studies of ulcerative colitis and Crohn's disease.
Our second drug candidate is CBP-201, a novel monoclonal antibody that targets IL-4R? and blocks a central pathway in allergic inflammation, and will be studied for the treatment of atopic dermatitis, asthma, and other inflammatory conditions. Additional programs included CBP-174, CBP-233, and CBP-312.
Media Contact:
Rosemary Chang
Tel: +86-512-53577866
[email protected]
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The planned phase 1 clinical trial is a randomized, double-blind, placebo-controlled study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CBP-201. At least 40 healthy subjects will be enrolled in this single ascending dose study.
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"We are very excited to begin the process of initiating our first-in-man study of CBP-201, a novel and highly potent monoclonal antibody against interleukin-4 receptor alpha (IL-4R?). IL-4R? is a clinically-validated target known to mediate the biological activities of both IL-4 and IL-13, two key cytokines driving a broad array of allergic inflammatory diseases," said Jeffery White, MD, Chief Medical Officer of Connect Biopharmaceuticals. "Preclinical studies showed that CBP-201 had superior potency and pharmacokinetic properties compared to existing IL-4R? antibodies currently in clinical development. Using well-validated biomarkers, we expect this phase 1 study to provide important safety, PK, and PD data with CBP-201 to support further clinical development in patients."
"We are extremely pleased that Connect has once again advanced a high-quality, internally-discovered drug candidate into clinical studies," said Dr. Zheng Wei, CEO of Connect. "The progress of CBP-201 further validated our efficient operational strategy, which combines our strong expertise in T-cell modulation with efficient collaborations with top-quality CROs to deliver new therapeutics for inflammatory diseases with high unmet need both in China and globally."
About Connect Biopharmaceuticals
Connect Biopharmaceuticals is a China-based global clinical-stage company focused on discovery and development of novel immune modulators for the treatment of autoimmune diseases and inflammation. Our drug discovery technology platform is built on the biology of T cell functions, which identifies molecules that target clinically-validated disease pathways.
Our lead drug candidate is CBP-307, an orally-active, next-generation S1P1 and S1P5 (a G-protein coupled receptor -GPCR) modulator for the treatment of a range of autoimmune disorders, including inflammatory bowel disease, psoriasis, multiple sclerosis and other autoimmune diseases. We have completed a phase 1b randomized, double-blind, placebo-controlled study that assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of CBP-307. In this study, CBP-307 exhibited an excellent safety profile and potent T cell modulation activity as well as optimal pharmacokinetic and pharmacodynamic profiles, demonstrating best-in-class potential. CBP-307 is entering phase 2 studies of ulcerative colitis and Crohn's disease.
Our second drug candidate is CBP-201, a novel monoclonal antibody that targets IL-4R? and blocks a central pathway in allergic inflammation, and will be studied for the treatment of atopic dermatitis, asthma, and other inflammatory conditions. Additional programs included CBP-174, CBP-233, and CBP-312.
Media Contact:
Rosemary Chang
Tel: +86-512-53577866
[email protected]
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SOURCE Connect Biopharmaceuticals, Ltd.
