Acerand Therapeutics has commenced its first human clinical trial of ACE-232, an oral CYP11A1 inhibitor designed for patients with metastatic castration-resistant prostate cancer (mCRPC).
The first patient has been dosed as part of this early-stage study, which is expected to feature 67 patients.
The Phase I trial, identified as NCT06801236, is being held across multiple centres in both the US and China. It is structured into two segments, a dose-escalation stage (Phase IA) and a dose-optimisation stage (Phase IB).
The main goals are to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and initial clinical activity of ACE-232. Additionally, the trial seeks to establish the recommended Phase II dose.
Professor Emmanuel Antonarakis, who is the director of Genitourinary Oncology at the Masonic Cancer Center, University of Minnesota, is acting as the global coordinating principal investigator for the study.
Antonarakis said: “I would like to congratulate the Acerand team, the research staff, and the first patient for helping us to reach this important milestone.”
Acerand Therapeutics said that preclinical studies have shown that ACE-232 has superior potency and efficacy compared to other CYP11A1 inhibitors like MK-5684. With favourable preclinical tolerability and a broad therapeutic window, the drug exhibits potential for effective clinical development.
ACE-232 functions by inhibiting CYP11A1, an enzyme crucial in steroid hormone biosynthesis. This inhibition aims to reduce androgen and steroid hormone production, presenting a new treatment approach for androgen-dependent prostate cancer, including cases resistant to enzalutamide or abiraterone.
Acerand Therapeutics specialises in developing innovative small-molecule therapies for oncology and metabolic disorders. With facilities in Shanghai and Indianapolis, the company utilises its platform to advance its pipeline of drug candidates from discovery to clinical trials.
