Alessa Therapeutics Announces FDA Fast Track Designation for Enolen, A First-Of-Its-Kind Treatment for Localized Prostate Cancer

Fast Track Designation Highlights Potential of Enolen to Address Unmet Medical Need for Patients with Low to Intermediate Risk, Localized Prostate Cancer

Company Expects to Provide Initial Findings from Enolen’s Phase 1 Trial Later This Year

SAN CARLOS, Calif.–(BUSINESS WIRE)–Alessa Therapeutics (“Alessa”), a clinical-stage biopharmaceutical company advancing novel localized drug delivery technology for the treatment of early-stage prostate cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Enolen^®, the Company’s lead product candidate for the treatment of low to intermediate risk, localized prostate cancer.

Fast Track designation is granted by the FDA to products that are developed to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. This designation is intended to facilitate development and expedite review of qualifying drugs. A drug that receives Fast Track designation may be eligible for more frequent meetings and communications with the FDA and rolling review of any application for marketing approval.

“Receiving Fast Track designation for Enolen is further evidence of the urgent need for new treatment options for early-stage prostate cancer. Patients living with prostate cancer deserve an alternative to active surveillance or being faced with the considerable negative side effects common with the more aggressive treatment options available today,” said Cam Gallagher, President and Chief Executive Officer of Alessa Therapeutics. “We will continue to collaborate closely with the FDA to advance a new treatment option for men suffering not only from the disease itself, but who often face a heavy burden in deciding between not treating their cancer or pursuing therapies with significant health and lifestyle consequences.”

Enolen utilizes novel anti-androgen eluting implants containing the FDA-approved prostate cancer compound enzalutamide. 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 potential side effects of systemic anti-androgen and testosterone-lowering drugs, including 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 potential negative side effects which can result from systemic exposure.

Enolen is currently being studied in a Phase 1 trial evaluating its safety, tolerability and preliminary efficacy for localized sustained delivery of enzalutamide into the prostate. Alessa expects to present initial findings from the study in 2026.

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. Alessa is advancing a pipeline of drug-eluting implants, initially focused on prostate cancer, with the Company’s lead clinical program, Enolen^®, currently being studied in a Phase 1 clinical trial for the treatment of low to intermediate risk, localized prostate cancer. 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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