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 study demonstrated a statistically significant improvement in complete lesion clearance compared to placebo, leading to a surge in Biofrontera's stock price.
The Phase III trial (NCT03573401) enrolled 187 participants diagnosed with sBCC. The primary composite endpoint, defined as complete clinical and histological clearance of a preselected "main target" BCC lesion per patient 12 weeks after the start of the last PDT cycle, was met with a 65.5% success rate in the Ameluz-PDT treatment group compared to only 4.8% in the placebo-PDT group.
Key Findings from the Phase III Trial
The study also revealed that 75.9% of participants treated with Ameluz-PDT achieved complete histological clearance of lesions, compared to 19% in the placebo arm. Furthermore, complete clinical clearance was observed in 83.4% of participants in the Ameluz-PDT arm, versus 21.4% in the placebo arm.
Secondary endpoints were also met, with 64.1% of Ameluz-PDT patients achieving total clearance of all sBCC lesions, compared to 4.8% of those treated with placebo-PDT. Patient satisfaction was 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
The Ameluz PDT therapy involves the application of Ameluz, a photosensitizing agent and porphyrin precursor, followed by illumination with the BF-RhodoLED lamp. This process induces photodynamic therapy, which selectively destroys 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 Market Impact
Biofrontera CEO and chairman Dr. Hermann Luebbert stated, "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." 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.
Current Landscape of sBCC Treatment
Superficial basal cell carcinoma is a common form of skin cancer, and current treatment options include surgical excision, cryotherapy, and topical medications. The Ameluz-PDT therapy offers a non-invasive alternative with demonstrated efficacy and high patient satisfaction, potentially filling an unmet need in the treatment of sBCC.
