Enolen (enzalutamide implant) / Alessa Therap - LARVOL DELTA

Alessa Therapeutics Receives Positive FDA Feedback Following Type C Meeting on Enolen’s Pivotal Phase 3 Trial Design (EIN Presswire) - "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....'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'."

FDA event • New P3 trial • Prostate Cancer

Alessa Therapeutics Announces Positive Preliminary Safety and Efficacy Data from Enolen Phase 1 Trial (Businesswire) - "Findings presented yesterday at EAU2026 by researchers at the NCI 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 18/20 patients (2 pending) showed a reduction in tumor volume in 84% of the lesions over an average duration of 35 days."

P1 data • Prostate Cancer

Alessa Therapeutics Announces FDA Fast Track Designation for Enolen, A First-Of-Its-Kind Treatment for Localized Prostate Cancer (Businesswire) - "Enolen utilizes novel anti-androgen eluting implants containing the FDA-approved prostate cancer compound enzalutamide....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."

Fast track • P1 data • Prostate Cancer