– CBP-174 in development for pruritus associated with allergic and inflammatory skin diseases, including atopic dermatitis, was observed to be safe and well-tolerated –
SAN DIEGO and TAICANG, SUZHOU, China, Aug. 30, 2022 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (NASDAQ:CNTB) (Connect Biopharma or the Company), a global, clinical-stage biopharmaceutical company developing T cell-driven therapies to treat inflammatory diseases, today announced it successfully completed its first-in-human Phase 1 study of CBP-174 designed to evaluate safety, tolerability, and pharmacokinetics (PK) in healthy adults. CBP-174, a highly selective, peripherally acting H3 receptor (H3R) antagonist drug candidate is in development to treat pruritus (itch) associated with allergic and inflammatory skin diseases, including atopic dermatitis (AD).
CBP-174 administered orally, was observed to be safe and well-tolerated across eight dose escalation cohorts evaluated up to a maximum dose of 16 mg or placebo in this randomized, double-blind, placebo-controlled, single ascending dose (SAD) study. There were no serious adverse events, and reported adverse events were predominantly mild in severity and no dose-limiting toxicities were identified. Other safety parameters, including vital signs, ECGs, and laboratory results showed no clinically notable safety findings. PK of CBP-174 exhibited rapid absorption with dose proportional increases in exposure followed by linear elimination.
"This promising first human data demonstrates good progress for CBP-174 as a novel treatment for pruritus associated with allergic and inflammatory skin conditions, such as atopic dermatitis, which afflicts millions of individuals worldwide," said Dr. Zheng Wei, Ph.D., Co-Founder and CEO of Connect Biopharma. "This is our first clinical trial for our third clinical-stage drug candidate, and we look forward to continuing the evaluation of CBP-174 as we work toward improving the quality-of-life outcomes for patients with debilitating dermatologic diseases."
Connect Biopharma is developing CBP-174, a highly selective, peripherally acting H3R antagonist for oral administration, to treat chronic pruritus associated with allergic and inflammatory skin conditions, including AD. Pre-clinical models have indicated that CBP-174 led to reductions in scratching in mice within the first 30 minutes of dosing, which could potentially translate to rapid reduction in pruritus in humans.
About the CBP-174 Phase 1 Trial
The Phase 1 trial sought to assess safety, tolerability, and PK of CBP-174 in healthy adults. The CBP-174 Phase 1 trial was a randomized, double-blind, placebo-controlled, SAD study. The study was conducted in Australia and included eight dose escalation cohorts and one extension cohort with administration of a single oral dose of CBP-174 or placebo. A total of 72 subjects were dosed with 8 subjects included in each cohort, whereby 54 and 18 subjects received CBP-174 and placebo, respectively.