Pharma Focus Asia

ESSA Pharma Announces Clinical Trial Support Agreement with Janssen

Wednesday, April 12, 2023

ESSA Pharma announced that the Company has entered into a clinical trial support agreement with Janssen Research & Development ("Janssen") to enable evaluation of ESSA's first-in-class N-terminal domain androgen receptor inhibitor, EPI-7386, in combination with apalutamide as well as the combination of EPI-7386 with abiraterone acetate plus prednisone in patients with prostate cancer.

Under the terms of the Agreement, ESSA will sponsor and conduct a Phase 1 clinical trial evaluating the safety, pharmacokinetics, drug-drug interactions, and preliminary anti-tumour activity of EPI-7386 when administered in combination with either apalutamide or abiraterone acetate plus prednisone. Janssen will supply apalutamide and abiraterone acetate. ESSA will retain all rights to EPI-7386.

This agreement enables to further study EPI-7386 in combination with apalutamide and abiraterone acetate and prednisone in different populations of patients with prostate cancer. Preliminary clinical data from EPI-7386 combination studies with standard-of-care antiandrogens in mCRPC patients have shown a favourable safety profile and encouraging early signs of anti-tumour activity.

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