ACEA Biosciences Announces Successful Completion of Phase I Clinical Study of Novel Autoimmune Disease Drug

ACEA Biosciences today announced the completion of its Phase 1 clinical study of AC0058, a novel irreversible Bruton’s Tyrosine Kinase (BTK) inhibitor, which is in development for the treatment of B cell-related autoimmune diseases, including rheumatoid arthritis and systemic lupus erythematosus. Fifty-six (56) healthy subjects participated in the double-blind, placebo-controlled trial, which served to evaluate AC0058’s safety, tolerability, pharmacokinetics, pharmacodynamics, and target engagement, when administered orally in either a single ascending dose (SAD), or seven-day multiple ascending doses (MAD). Both the SAD and MAD trials successfully met their primary endpoints, and the maximum tolerated dose was not reached in either case. AC0058 was found to be safe and well-tolerated.

“AC0058 is another result of ACEA’s unique drug discovery and development capabilities which have, over the past two years, advanced multiple molecules into the clinic in both China and the United States,” said Xiao Xu, M.D., Chief Executive Officer of ACEA. “By leveraging our expertise in covalent tyrosine kinase inhibitors, we’ve been able to rapidly develop AC0058, and the properties of this small molecule make it well-suited for the treatment of chronic diseases, where safety is paramount. Based on the preliminary and encouraging safety and PK/PD data, and the fact that AC0058 has a profile that is amenable to chronic oral dosing, we are moving forward with plans to initiate Phase 2 clinical trials. We’ll be announcing additional details from the trial and complete data outcomes at future clinical meetings and conferences.”

About AC0058

AC0058 is a small molecule that selectively inhibits Bruton’s tyrosine kinase (BTK) phosphorylation and its subsequent downstream signaling. In preclinical studies AC0058 was…

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