Tuesday, November 01, 2022
ESSA Pharma Inc., a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, today announced that Janssen Research and Development ("Janssen") is suspending enrollment into the Phase 1 clinical study of EPI-7386 with apalutamide or EPI-7386 with abiraterone acetate plus prednisone in metastatic castration-resistant prostate cancer ("mCRPC") patients as a result of operational recruitment challenges.
Before suspending enrollment, Janssen treated three mCRPC patients (pre-chemotherapy) with the combination of EPI-7386 and apalutamide or abiraterone acetate plus prednisone for up to four months of therapy. In all three patients, the combination of both investigational drug products was safe and well tolerated, and yielded sufficient exposures of each investigational drug product, indicative of pharmacological activity. Initial clinical activity was observed in some patients, with two of the three patients achieving a prostate-specific antigen ("PSA") reduction of 90% ("PSA90") within 12 weeks.
"While we are disappointed that Janssen will not be completing this study, we thank Janssen for the conduct of the study to date and the patients who participated in the study. We are encouraged by the favorable safety, pharmacokinetic, and initial clinical activity in these patients as these data further support the data generated in the EPI-7386 combination study with enzalutamide that ESSA is conducting. We are in discussions with Janssen to supply abiraterone acetate and apalutamide for an ESSA-sponsored combination study and expect to provide more details in the coming months," said David Parkinson, Chief Executive Officer of ESSA.