Biofrontera Updates Patient Recruitment for Ameluz-PDT Trial

Fully 70 percent of the planned 186 patients have been enrolled in Biofrontera Inc.'s phase III clinical study for the treatment of superficial basal cell carcinoma with Ameluz photodynamic therapy in combination with the BF-RhodoLED lamp in the U.S.

Fully 70 percent of the planned 186 patients have been enrolled in Biofrontera Inc.'s phase III clinical study for the treatment of superficial basal cell carcinoma (sBCC) with Ameluz photodynamic therapy (Ameluz-PDT) in combination with the BF-RhodoLED lamp in the U.S, the company reports.

As the news broke, the company's shares were trading at 17.99 percent higher at $4 a share. 

Patient recruitment for this study has been ongoing since 2018 with 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,” says CEO Erica Monaco, in a news release. “Following successful FDA approval, Ameluz would be the only drug in the United States approved for the treatment of superficial BCC with PDT, which we expect to further increase the growth potential of our flagship product Ameluz in the medium term. “

This randomized, double-blind and placebo-controlled study will include 186 patients at 12 study sites in the United States. Each patient will have one or more clinically and histologically confirmed superficial BCC. 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 completion of 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 a main sBCC lesion, which will be selected at the beginning of the study. In addition, data on drug safety as well as secondary efficacy parameters of all sBCCs will be evaluated in the study.