Accutar Biotechnology Receives NMPA Clearance of IND Application for AC0176 in Prostate Cancer

CRANBURY, N.J. & SHANGHAI--(BUSINESS WIRE)--Accutar Biotechnology, Inc., a clinical stage biotechnology company focusing on artificial intelligence (AI)-empowered drug discovery, announces that the China National Medical Products Administration (NMPA) 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 Androgen Receptor (AR) protein with high potency and selectivity.

“Prostate cancer is one of the most common cancers among men in China, and the speed of increase in its incidence and death rates ranks highest in China. We are excited about the IND clearance of AC0176 in China, after its IND clearance and initiation of the first-in-human Phase 1 study in the US early this year,” said Jie Fan, Ph.D., Chief Executive Officer, Accutar Biotechnology, Inc. “We look forward to accelerating the development of AC0176 and furthering our commitment to bringing innovative medicines to patients worldwide.”

The Phase 1 study in China will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC0176 treatment in Chinese patients with mCRPC. Accutar expects to begin enrollment of this study in the second half of this year.

About AC0176

AC0176 is an investigational orally bioavailable, chimeric degrader of androgen receptor (AR) for the potential treatment of prostate cancers. AR is a hormonal transcription factor, and plays important roles during prostate cancer onset and progression. 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.

Be transformative. For patients.

To learn more about Accutar, please visit us at www.accutarbio.com.