Biofrontera Inc (NASDAQ:BFRI) has provided an update on the patient recruitment for the Phase 3 study for superficial basal cell carcinoma (sBCC) with Ameluz photodynamic therapy (PDT) combined with BF-RhodoLED lamp in the U.S.
- To date, 70% of the planned 186 patients have been enrolled in the study.
- Patient recruitment for this study has been ongoing since 2018, with the completion of patient recruitment anticipated by the end of 2022.
- “Due to a demanding study protocol mandated by the FDA, the recruitment process has been taking a considerable amount of time and was additionally slowed down by the Covid pandemic, but has recently picked up again,” said CEO Erica Monaco.
- Patients will receive one cycle of two PDTs 1-2 weeks apart, which may be repeated after three months if required.
- The last assessment of the patients will take place three months after the last PDT cycle.
- After completing the trial, Biofrontera will follow patients for an additional 5-year period.
- Each patient will be treated with Ameluz-PDT or placebo-PDT.
- The primary study endpoint is the composite complete clinical and histological clearance of the main sBCC lesion selected at the beginning of the study.
- Price Action: BFRI shares are up 21.20% at $4.11 during the market session on the last check Tuesday.
