ESSA Pharma Terminates Masofaniten Development After Phase 2 Trial Failure in Prostate Cancer

Trial Termination:
ESSA Pharma has terminated its Phase 2 clinical trial evaluating masofaniten combined with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) due to a low likelihood of achieving the primary endpoint of a 90% PSA response rate.

Efficacy Comparison:
The interim analysis showed that the enzalutamide control arm performed better than historical controls and similar to the combination therapy, with PSA90 response rates of 73% for enzalutamide monotherapy versus 64% for the masofaniten plus enzalutamide combination.

Strategic Review:
ESSA Pharma will initiate a strategic review process to maximize shareholder value, considering options such as M&A activity, asset sales, or restructuring.

Financial Position:
The company has $126.8 million in cash reserves and $124.3 million in net working capital as of September 30, 2024.

Clinical Development:
All additional clinical studies with masofaniten will be terminated, marking the end of this development program.

Previous Expectations:
Earlier data presented at the 2024 ESMO Congress showed promising PSA reductions with the combination therapy, but the Phase 2 trial did not meet the expected efficacy profile.

Regulatory Status:
Masofaniten had received fast track designation from the FDA in September 2020 for the treatment of adult patients with mCRPC who are resistant to standard-of-care therapies.