SAN DIEGO--(BUSINESS WIRE)--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.”
AC0058 is a small molecule that selectively inhibits Bruton’s tyrosine kinase (BTK) phosphorylation and its subsequent downstream signaling. In preclinical studies AC0058 was shown to inhibit lymphocyte (predominantly B-cell) activation as well as inflammatory cytokine production in monocytes.
About ACEA Biosciences
ACEA Biosciences, Inc. (ACEA) is a privately owned biotechnology company focused on the development and commercialization of innovative cell analysis instrumentation for life sciences, and on the discovery and development of novel pharmaceutical products for the treatment of chronic diseases. ACEA’s instruments, xCELLigence® and NovoCyte®, are used in preclinical drug discovery and development, toxicology, safety pharmacology, disease studies, and basic academic research. More than 3,000 instruments have been placed globally, leading to >1,350 peer-reviewed publications from both academia and the pharmaceutical industry in diverse applications spanning everything from cancer immunotherapy and cardiotoxicity to chemotactic migration and GPCR inhibition. ACEA has leveraged its technology platforms to develop a robust pipeline of clinical and preclinical small molecules for the treatment of cancer and autoimmune diseases, with two clinical stage programs running in China and the USA. ACEA Biosciences is headquartered in San Diego, California with world-class manufacturing operations in Hangzhou, China.
For more information on ACEA’s ongoing clinical trials please visit www.clinicaltrials.gov.