On Thursday, ESSA Pharma Inc. EPIX introduced its plans to terminate the Section 2 trial of masofaniten mixed with enzalutamide versus enzalutamide single agent in sufferers with metastatic castration-resistant prostate most cancers (mCRPC) naïve to second-generation antiandrogens.
This resolution was based mostly on a protocol-specified interim evaluation of the protection, PK, and efficacy knowledge, which confirmed a a lot increased price of PSA90 response in sufferers handled with Pfizer Inc’s PFE Xtandi (enzalutamide) monotherapy (which is the usual of take care of this affected person inhabitants) than anticipated based mostly on historic knowledge.
As well as, there was no clear efficacy profit seen with the mixture of masofaniten plus enzalutamide in comparison with enzalutamide single agent.
A futility evaluation decided a low chance of assembly the prespecified main endpoint of the examine.
The mix of masofaniten plus enzalutamide was well-tolerated with no new security indicators and a security profile much like that seen in Section 1 research.
“We made the tough resolution to terminate this Section 2 examine following the interim evaluation as a result of we concluded that the rising efficacy profile of masofaniten mixed with enzalutamide would not going meet the first endpoint of the examine, nor our inner necessities for a prostate most cancers remedy candidate,” stated David Parkinson, President, and CEO.
As a part of the hassle to focus its assets, ESSA can be planning to terminate the opposite remaining company-sponsored and investigator-sponsored medical research evaluating masofaniten both as a monotherapy or together with different brokers.
As of September 30, 2024, the corporate had accessible money reserves and short-term investments of $126.8 million and web working capital of $124.3 million.
In September, ESSA Pharma introduced the presentation of up to date dose escalation knowledge from its Section 1/2 examine of masofaniten (previously EPI-7386) together with enzalutamide on the 2024 European Society for Medical Oncology (ESMO) Congress.
Throughout all dose cohorts, 88% of sufferers (14 of 16) achieved PSA50, 88% of sufferers (14 of 16) achieved PSA90, 69% of sufferers (11 of 16) achieved PSA90 in lower than 90 days, and 63% of sufferers (10 of 16) achieved PSA <0.2ng/mL.
Worth Motion: EPIX inventory was down 69.80% at $1.57 through the premarket session on the final verify on Friday.
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