Biofrontera AG has announced positive topline results from its Phase III clinical trial evaluating Ameluz gel in combination with photodynamic therapy (PDT) using the BF-RhodoLED lamp for the treatment of superficial basal cell carcinoma (sBCC). The trial's success marks a significant step forward in non-invasive treatment options for this common form of skin cancer.
The Phase III trial (NCT03573401) enrolled 187 participants diagnosed with sBCC. The study met its primary composite endpoint, demonstrating complete clinical and histological clearance of a preselected "main target" BCC lesion in 65.5% of patients treated with Ameluz-PDT, compared to only 4.8% in the placebo-PDT group. This statistically significant difference underscores the efficacy of the Ameluz-PDT therapy.
Key Findings from the Phase III Trial
Beyond the primary endpoint, the trial also achieved notable success in several secondary endpoints. Complete histological clearance of lesions was observed in 75.9% of participants in the Ameluz-PDT arm, compared to 19% in the placebo arm. Furthermore, 83.4% of participants receiving Ameluz-PDT achieved complete clinical clearance, versus 21.4% in the placebo group.
Additionally, 64.1% of Ameluz-PDT patients experienced total clearance of all sBCC lesions, a stark contrast to the 4.8% observed in the placebo-PDT group. Patient satisfaction was also high, with 64.3% of patients in the Ameluz-PDT arm rating the overall treatment satisfaction and aesthetic outcome as very good, and an additional 22.2% rating it as good.
Mechanism of Action and Current Approvals
Ameluz is a photosensitizing agent and porphyrin precursor that, when used in conjunction with the BF-RhodoLED lamp, delivers PDT to kill cancerous and precancerous cells. In the United States, Ameluz-PDT therapy is currently approved for the treatment of mild to moderate actinic keratoses on the face and scalp.
Regulatory Pathway and Future Plans
"Once we finish the one-year follow-up phase in December, we will be in a position to submit our dossier to the US Food and Drug Administration (FDA) around the end of Q2 / early Q3 of 2025," said Dr. Hermann Luebbert, CEO and chairman of Biofrontera.
Market Response
Following the announcement of these positive results, Biofrontera's stock experienced a significant increase, closing at $1.23 on October 31, a 31.71% rise compared to the market open on the same day. This market reaction reflects investor confidence in the potential of Ameluz-PDT as a valuable treatment option for sBCC.
