ImPact Biotech Completes Treatment in Phase 3 ENLIGHTED Trial of Padeliporfin VTP for LG-UTUC

ImPact Biotech, a clinical-stage biotechnology company developing Padeliporfin Vascular Targeted Photodynamic therapy (VTP), has announced the completion of treatment for all 91 patients enrolled in its Phase 3 ENLIGHTED trial. The pivotal study evaluates Padeliporfin VTP in patients with low-grade upper tract urothelial carcinoma (LG-UTUC). This treatment completion, along with a positive pre-NDA meeting held with the U.S. Food and Drug Administration (FDA) in April 2026, supports the company's plans to present interim trial data at the ESMO Congress in October 2026 and submit a New Drug Application (NDA) in 2027.

In written feedback following the pre-NDA meeting, the FDA acknowledged the potential clinical meaningfulness of Padeliporfin VTP in LG-UTUC, including the potential clinical value of durable complete response in the treated area. The agency confirmed a registrational pathway that allows ImPact Biotech to leverage supplemental non-clinical modules from a prior NDA submission for Padeliporfin VTP in advanced localized prostate cancer, streamlining the 2027 submission package. Furthermore, the company is actively discussing a potential expanded access program (EAP) with the FDA to enable qualifying US patients to access Padeliporfin VTP prior to formal regulatory approval.

The Phase 3 ENLIGHTED study is a single-arm, non-randomized, open-label trial conducted across 29 clinical sites globally. The trial is divided into an Induction Treatment Phase and a Maintenance Treatment Phase. Padeliporfin, a photosensitizing drug, is administered intravenously and locally activated in the tumor microenvironment via a 10-minute laser fiber illumination during a ureteroscopy. The primary objective of the study is to evaluate the response rate at the end of the induction phase, while secondary objectives assess safety, tolerability, and duration of response.