COAKS (Copenhagen Actinic Keratosis Study)
In collaboration with Studies & Me, Coegin Pharma will carry out a double-blind, placebo-controlled, combined phase I / II clinical study led by Professor Merete Hædersdal, head of research at Bispebjerg Hospital. The study includes about 60 patients with actinic keratosis for topical treatment with the drug candidate AVX001 in different strengths. The purpose of the study is to investigate safety and efficacy during a shorter treatment period where digital methods with the patient in the center are also used.
In March 2021, Coegin Pharma submitted an application to the Danish Scientific Ethics Committee and the Danish Medicines Agency. In July, the company received approval from the Danish Medicines Agency. The final approval of the study from the Scientific Ethics Committee is expected shortly. The delayed response from the ethics committee is based on a general extended case management which is not unusual. The company continues to assess that the overall schedule can be kept and that the results from the clinical study can be presented during the first quarter of 2022.
Basal cell carcinoma
We are planning to conduct a Phase IIa trial in basal cell carcinoma in 2022, and our ambition is to complete it before the end of the year.