Essa Pharma Shares Drop 26% After Janssen Suspends Enrollment for Trials

By Chris Wack

Essa Pharma Inc. shares were down 26% to $3.25 in premarket trading after the company said that Janssen Research & Development is suspending enrollment in the Phase 1 clinical study of EPI-7386 with apalutamide or EPI-7386 with abiraterone acetate plus prednisone in metastatic castration-resistant prostate cancer patients as a result of operational recruitment challenges.

Before suspending enrollment, Janssen treated three mCRPC patients with the combination of EPI-7386 and apalutamide or abiraterone acetate plus prednisone for up to four months of therapy, the company said.

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 reduction of 90% within 12 weeks, the company said.

"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," David Parkinson, chief executive of Essa, said.

"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."

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

October 31, 2022 08:21 ET (12:21 GMT)

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