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December 27, 2021updated 11 Jul 2022 2:14pm

FDA approves IND application of Accutar for prostate cancer treatment trial

The Phase I trial will assess the preliminary anti-tumour activity, safety, pharmacokinetics and tolerability of AC0176.

The US Food and Drug Administration (FDA) has approved  Accutar Biotechnology’s Investigational New Drug (IND) application for Phase I clinical trial of AC0176 to treat metastatic castration-resistant prostate cancer (mCRPC).

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An investigational orally bioavailable, chimeric degrader molecule, AC0176 is designed to target and degrade androgen receptor (AR) to treat prostate cancer.

AR is a hormone-regulated transcription factor that plays a key role in initiation and progression of prostate cancer.

Accutar stated that AC0176 showed strong and selective degradation of AR protein with wide coverage of AR mutants and favourable pharmacological properties in the preclinical studies.

In the Phase 1 study, AC0176’s pharmacokinetics, preliminary anti-tumour activity, safety, and tolerability will be evaluated to treat mCRPC patients.

Accutar Biotechnology CEO Jie Fan said: “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.

“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 company expects to commence enrolment of participants for the Phase I clinical trial in the first quarter of next year.

Recently, CytoDyn received positive response from the US FDA to commence a Phase III clinical trial of leronlimab to treat Covid-19.

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