Acerand Therapeutics Initiates First-in-Human Phase I Clinical Trial of ACE-232, a Novel CYP11A1 Inhibitor for Advanced Prostate Cancer
SHANGHAI & INDIANAPOLIS--(BUSINESS WIRE)--Acerand Therapeutics, a clinical-stage biotech company focusing on the discovery and development of innovative small-molecule therapies in oncology, today announced the dosing of the first patient in its first-in-human Phase I clinical trial (NCT06801236) of ACE-232, a novel oral inhibitor of CYP11A1. The trial is being conducted in patients with metastatic castration-resistant prostate cancer (mCRPC).
'I would like to congratulate the Acerand team, the research staff, and the first patient for helping us to reach this important milestone,' says Dr. Antonarakis.
This multicenter Phase I study is being conducted in both the United States and China. The study comprises two parts: a dose-escalation phase (Phase IA) and a dose-optimization phase (Phase IB). The primary objectives are to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), as well as preliminary clinical activity of ACE-232, and to determine the recommended Phase II dose (RP2D). Professor Emmanuel Antonarakis, Director of Genitourinary Oncology at Masonic Cancer Center, University of Minnesota, is serving as the global coordinating Principal Investigator for the study. 'I would like to congratulate the Acerand team, the research staff, and the first patient for helping us to reach this important milestone,' says Dr. Antonarakis.
Preclinical data demonstrated that ACE-232 possesses superior potency, efficacy, and pharmacokinetic properties (flat PK curve and long half-life profile) compared to other investigational CYP11A1 inhibitors, including MK-5684 (Opevesostat, formerly known as ODM-208). ACE-232 showed excellent tolerability in preclinical models, presenting a wide therapeutic window for clinical development.
The initiation of this trial marks a significant milestone for Acerand, representing its first clinical study in the United States and highlighting its strategic commitment to the global development of innovative cancer therapies that address major unmet medical needs.
About ACE-232
ACE-232 is a highly potent and selective small-molecule inhibitor of CYP11A1, a key adrenal enzyme involved in the first and rate-limiting step of steroid hormone biosynthesis. By targeting CYP11A1, ACE-232 aims to suppress the production of androgens and other steroid hormones, offering a novel therapeutic mechanism for the treatment of androgen-dependent (including enzalutamide or abiraterone-resistant) prostate cancer.
About Acerand Therapeutics
Acerand Therapeutics is a biotech company dedicated to discovering and developing novel small-molecule therapies for oncology and metabolic diseases. With research and development hubs in Shanghai, China, and Indianapolis, USA, ACE-232 leverages its proprietary innovation platform and operational efficiency to deliver a highly differentiated pipeline of drug candidates from discovery to clinical trials.
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