Accutar Biotechnology Announces FDA Clearance of IND Application for Phase 1 Trial of AC0176 in Prostate Cancer

Business Wire India

Accutar Biotechnology, Inc., a biotechnology company focusing on artificial intelligence (AI)-empowered drug discovery, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug application (IND) for AC0176 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). AC0176 is an orally bioavailable, chimeric degrader molecule designed to target and degrade androgen receptor (AR) with high potency, selectivity, and broad mutant coverage. AR is a hormone-regulated transcription factor, and its activation plays a critical role in prostate cancer initiation and progression. Accutar expects to begin enrollment of a Phase 1 clinical trial for AC0176 in the first quarter of 2022.

"The IND clearance for AC0176 is another important validation, after our AC0682 entered the clinic recently, that our AI platform can support and advance the discovery of potentially differentiated clinical candidates quickly, especially complex compounds such as chimeric degraders," said Jie Fan, Ph.D., Chief Executive Officer of Accutar Biotechnology, Inc. "The IND clearance for AC0176 is also critical towards offering a potential new treatment for prostate cancer based on a differentiated mechanism of action from second generation nonsteroidal AR antagonists, which are the current standard of care for this patient population. We look forward to the clinical benefit that AC0176 treatment can potentially provide to prostate cancer patients.”

The Phase 1 study will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC0176 treatment in mCRPC patients.

About AC0176

AC0176 is an investigational orally bioavailable, chimeric degrader of androgen receptor (AR) for the potential treatment of prostate cancers. In preclinical studies, AC0176 has demonstrated potent and selective AR protein degradation with broad coverage of AR mutants, favorable pharmacological properties, as well as promising anti-tumor activities in animal models.

About Accutar Biotechnology, Inc.

Accutar is a clinical stage biotech company focused on AI-empowered drug discovery, and its application to the discovery and development of clinically differentiated medicines.

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