**ESSA Pharma Terminates Phase 2 Study on Prostate Cancer Treatment Masofaniten**

**UNITED STATES SECURITIES AND EXCHANGE COMMISSION: FORM 8-K FILING**

On November 1, 2024, ESSA Pharma Inc. (NASDAQ: EPIX), a clinical-stage pharmaceutical company headquartered in Vancouver, Canada, announced the termination of its Phase 2 clinical trial evaluating masofaniten combined with enzalutamide in patients suffering from metastatic castration-resistant prostate cancer.

The decision to discontinue the trial was based on a protocol-specified interim review of safety, pharmacokinetics, and efficacy data. The analysis revealed that the combination of masofaniten and enzalutamide did not show significant efficacy benefits compared to enzalutamide single-agent treatment. This conclusion was further supported by a futility analysis, indicating a low likelihood of meeting the primary endpoint of the study.

Additionally, as part of its strategy to optimize resource allocation, ESSA Pharma plans to terminate all other ongoing clinical studies evaluating masofaniten, either as a monotherapy or in combination with other agents. This includes both company-sponsored and investigator-sponsored trials.

Following this development, the company intends to explore various strategic options to maximize shareholder value. ESSA Pharma emphasized its commitment to delivering meaningful clinical benefits while maintaining a strong safety profile for patients participating in its trials.

Richard Glickman, the Chairman of the Board of Directors of ESSA, highlighted the company’s focus on preserving capital and its plans to initiate a strategic review process.

As of September 30, 2024, the company reported cash reserves and short-term investments of $126.8 million, with no long-term debt facilities. ESSA Pharma had 44,388,551 common shares issued and outstanding, along with 2,920,000 common shares issuable upon the exercise of prefunded warrants at an exercise price of $0.0001.

Masofaniten, formerly known as EPI-7386, is a first-in-class investigational oral medication designed to inhibit the androgen receptor signaling pathway responsible for prostate cancer growth. The U.S. FDA has granted Fast Track designation for masofaniten to treat adult male patients with metastatic castration-resistant prostate cancer resistant to standard treatments.

The announcement of the trial termination and strategic evaluation resulted from an in-depth assessment of the Phase 2 clinical trial outcomes, affirming ESSA Pharma’s commitment to pioneering novel therapies for prostate cancer treatment.

This news release contains forward-looking statements subject to various risks and uncertainties that could significantly impact the company’s future results. ESSA Pharma plans to update stakeholders, as necessary, in compliance with United States and Canadian securities laws.

For more information about ESSA Pharma Inc., please visit their website at www.essapharma.com.

By: MarketBeat Financial News

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read ESSA Pharma’s 8K filing here.

About ESSA Pharma

(Get Free Report)

ESSA Pharma Inc, a clinical stage pharmaceutical company, focuses the development of small molecule drugs for the treatment of prostate cancer. The company’s lead candidate EPI-7386, an androgen receptor based resistance mechanisms that develop in patients with castration-resistant prostate cancer and metastatic castration-resistant prostate cancer.

See Also