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.
