ESSA Pharma has signed a clinical trial support agreement with Janssen Research & Development to evaluate its EPI-7386 combinations for the treatment of men with prostate cancer.
As per the agreement, Janssen will supply ESSA with apalutamide and abiraterone acetate for a Phase I clinical trial which will be sponsored and conducted by the latter.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The trial will evaluate 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.
Patients with metastatic castration-resistant prostate cancer (mCRPC) and high-risk metastatic castration-sensitive prostate cancer (mCSPC) will receive EPI-7386 along with abiraterone acetate plus prednisone in Cohort A of the Phase I trial.
In Cohort B, a window of opportunity study, non-metastatic CRPC patients will be dosed with single agent EPI-7386 before adding standard-of-care apalutamide for up to 12 weeks.
ESSA president and CEO David Parkinson said: “We are pleased to have this agreement in place in order to further investigate EPI-7386 in combination with apalutamide and abiraterone acetate plus prednisone in a variety of prostate cancer patient populations.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalData“Preliminary clinical data from EPI-7386 combination studies with standard-of-care antiandrogens in mCRPC patients have shown a favorable safety profile and encouraging early signs of anti-tumour activity.
“We look forward to examining EPI-7386 with apalutamide and abiraterone acetate with prednisone in additional prostate cancer populations to assess the safety, tolerability, optimal dose(s) and preliminary anti-tumour activities of these approaches.”
Across the globe, ESSA will retain all rights to the oral, small molecule inhibitor of the N-terminal domain of the androgen receptor, EPI-7386.
The company is also evaluating EPI-7386 in combination with enzalutamide in a Phase I/II trial in metastatic CRPC patients who are yet to receive treatment with second-generation antiandrogen therapies.
