Biofrontera Inc. provides Update on Patient Recruitment for Phase 3 Study for the Treatment of sBCC With Ameluz-PDT

Biofrontera Inc. recently provided an update on the patient recruitment for the Phase 3 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 US. 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 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. “Following successful FDA approval, Ameluz would be the only drug in the US 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 US. 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 3 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.

According to the Skin Cancer Foundation, within the total of 5.4 million annual nonmelanoma skin cancers in the US, approximately 3.6 million skin cancer incidence are BCCs (source: https://www.skincancer.org/blog/our-new-approach-to-a-challenging-skin-cancer-statistic/)

This Phase 3 clinical study, as well as two other clinical studies currently being performed by Biofrontera AG and its Germany-based subsidiaries (together the “Licensor”), focuses on optimizing and expanding the market positioning of the company’s in-licensed FDA-approved prescription drug Ameluz for PDT in the US. Within the scope of the license and supply agreement (LSA) between Biofrontera Inc. and the Licensor, the company holds the exclusive rights to market and sell Ameluz and the PDT-lamps BF-RhodoLED as well as the new RhodoLED XL in the US. Under the terms of the LSA, Biofrontera Inc. purchases Ameluz from the Licensor for a transfer fee. In exchange for the transfer fee paid for the in-licensed products, the Licensor ensures the manufacturing and the supply of the products as well as responsibility for certain other aspects such as regulatory approvals and quality assurance. In addition, the LSA calls for the Licensor to perform and finance an extensive clinical study program to expand the FDA-approval of Ameluz in the US market.

Biofrontera Inc. is a US-based biopharmaceutical company commercializing a portfolio of pharmaceutical products for the treatment of dermatological conditions with a focus on photodynamic therapy (PDT) and topical antibiotics. The company’s licensed products are used for the treatment of actinic keratoses, which are pre-cancerous skin lesions, as well as impetigo, a bacterial skin infection. For more information, visit www.biofrontera-us.com.