Alessa Therapeutics Receives Positive FDA Feedback Following Type C Meeting on Enolen’s Pivotal Phase 3 Trial Design

FDA Confirms Single Study with Primary Endpoint of Progression-Free Survival Sufficient for NDA; company expects to begin pivotal Phase 3 trial in mid-2027

SAN CARLOS, CA, UNITED STATES, July 1, 2026 /EINPresswire.com/ -- Alessa Therapeutics (“Alessa”), a clinical-stage biopharmaceutical company advancing novel localized drug delivery technology for the treatment of early-stage prostate cancer, today announced that it received positive feedback from its Type C meeting with the U.S. Food and Drug Administration (FDA) for its planned pivotal Phase 3 trial for Enolen^®, the Company’s lead product candidate for the treatment of low to intermediate risk, localized prostate cancer.

The FDA confirmed that a single trial comparing Enolen to active surveillance is sufficient to support a New Drug Application (NDA) filing toward the front-line treatment of localized prostate cancer. In addition, the FDA confirmed that no additional clinical trials beyond the ongoing Phase 1 trial will be required before proceeding to this pivotal trial, nor would any additional non-clinical work be needed.

“Our productive discussions with the FDA have established a clearly defined and achievable clinical development pathway for Enolen,” said Cam Gallagher, President and Chief Executive Officer of Alessa Therapeutics. “Pre-clinical and clinical results to date clearly demonstrate the important role Enolen could play as an alternative to both active surveillance and to aggressive treatment options which bring with them significant negative side effects. As we continued to progress our Phase 1 trial of Enolen in two additional cohorts, we expect to begin this pivotal Phase 3 trial in mid-2027.”

Enolen utilizes novel anti-androgen eluting implants containing the FDA-approved prostate cancer compound enzalutamide. It is currently being studied in a Phase 1 trial evaluating its safety, tolerability, and preliminary efficacy for localized sustained delivery of enzalutamide into the tumors of men with prostate cancer. The study first launched at the National Cancer Institute (NCI), and is now actively enrolling patients at eight sites across the U.S.

The positive feedback received by the FDA following the Type C meeting builds upon the recent momentum achieved by Alessa in the development and advancement of Enolen. Earlier this year, Alessa announced that Enolen received Fast Track designation by the FDA, which is granted to products that are developed to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. The designation is intended to facilitate development and expedite review of qualifying drugs.

“We believe that this novel pathology-based primary endpoint provides the ideal foundation for demonstrating the efficacy of Enolen clinically and provides a rapid path to potentially deliver an urgently needed new treatment option to patients with early-stage prostate cancer,” said Pamela Munster, M.D., Chief Scientific Advisor and founder of Alessa. “We are pleased to be in alignment with the FDA on our development strategy for Enolen and look forward to continuing our advancement of this much needed therapy.”

About Enolen^®
Enolen leverages Alessa’s proprietary local delivery technology which can deliver anti-androgens directly to diseased tissue in the prostate. This localized delivery can help eliminate the side effects of systemic anti-androgen and testosterone-lowering drugs, including fatigue, sexual dysfunction, muscle mass loss, cognitive issues, metabolic syndrome and cardiovascular events.

Preclinical and clinical studies to date demonstrate that Alessa’s implant technology can deliver durable and continuous release of effective anti-cancer agents, achieving high local drug concentrations while minimizing the negative side effects which can result from systemic exposure.

Preliminary findings from the Phase 1 trial presented by NCI researchers earlier this year demonstrated that all 20 patients enrolled in the initial cohort were successfully implanted. These implantations achieved very high intraprostatic enzalutamide levels with minimal systemic drug exposure and resulted in no delay to surgery. Furthermore, pre-radical prostatectomy MRI’s conducted for 20 patients showed a reduction in tumor volume in 86% of the lesions over an average duration of 36 days. There were no reported effects on testosterone levels or negative effects on sexual function. Reported side effects were consistent with a biopsy-like procedure, and without impact on future surgery or imaging.

About Alessa Therapeutics
Alessa Therapeutics is a clinical-stage biopharmaceutical company pioneering a proprietary drug-delivery technology platform for the sustained and localized release of clinically proven prostate cancer therapies. Developed by Dr. Pamela Munster and her team at the University of California, San Francisco, Alessa’s patented drug-eluting implants, each about the size of a grain of rice, can provide two or more years of continuous drug elution directly to diseased tissue, thus eliminating the side effects that can result from systemic exposure to certain prostate cancer drugs. Founded in 2018, Alessa is backed by leading healthcare investors including Cure Ventures and Mission BioCapital. Learn more at alessatherapeutics.com.

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