Biofrontera has announced topline results from a Phase III trial evaluating its drug-device therapy, Ameluz gel and photodynamic therapy (PDT) with BF-RhodoLED lamp, as a treatment for superficial basal cell carcinoma (sBCC).
The drug-device combination met the primary composite endpoint of complete clinical and histological clearance of one preselected “main target” BCC lesion per patient 12 weeks after the start of the last PDT cycle, with Ameluz-PDT treatment achieving 65.5% success, compared to 4.8% success seen in the placebo-PDT group.
“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 the Massachusetts-based company.
Following the announcement, Biofrontera’s stock was up to $1.23 at market close yesterday (31 October), a 31.71% rise compared to the market open on the same day.
The Phase III trial (NCT03573401) enrolled 187 participants with sBCC. Complete histological clearance of lesions was seen in 75.9% of the participants treated with Ameluz-PDT, compared to 19% in the placebo arm. Furthermore, complete clinical clearance was seen in 83.4% of participants in Ameluz-PDT arm, compared to 21.4% who received placebo-PDT treatment.
The trial also met the secondary endpoint with 64.1% of Ameluz-PDT patients achieving total clearance of all sBCC lesions compared to only 4.8% of those treated with placebo-PDT. Additionally, 64.3% of patients in the Ameluz-PDT arm rated the overall treatment satisfaction and aesthetic outcome as very good, with 22.2% rating it as good.
The Ameluz PDT therapy uses Ameluz, a photosensitising agent and porphyrin precursor, in combination with a BF-RhodoLED lamp to administer PDT therapy and kill cancerous and precancerous cells. In the US, the Ameluz PDT therapy is approved to treat mild to moderate actinic keratoses on the face and scalp.
PDT therapy is also being evaluated for eye disorders. A US-based company PhotoPharmics is investigating its Celeste phototherapy device as a functional treatment for Parkinson’s disease.
