Berlin Cures has initiated a Phase II clinical trial of its lead drug candidate BC 007 in the indication Long Covid.
BC 007’s potential is based on the data generated in the lab using sera from patients with Long Covid. Four cases have been studied to date.
The first patients in the study were admitted to Havelhöhe and Münster University hospitals in Germany.
The study intends to evaluate the tolerability and efficacy of BC 007 in Long Covid patients and obtain meaningful and robust results.
Positive data from this study will be used to initiate a larger Phase III study.
The first results of the Phase II clinical trial are anticipated early next year.
Clinical development of the drug will be supported by Dr Axel Mescheder, Berlin Cures’ new chief medical officer (CMO).
Berlin Cures CEO Oliver von Stein said: “As CMO, he will be a driving force behind Berlin Cures’ efforts to bring relief and a cure to patients suffering from functional autoantibodies (fAAB)-associated diseases.
“Together, we will work towards transforming our platform technology into a therapeutic solution for millions of patients.”
BC 007 molecule effectively neutralises fAAB. Its effectiveness has been observed in a Phase I study in fAAB-positive healthy volunteers and Phase IIa trial in patients with heart failure.
Mescheder said: “Berlin Cures’ platform technology holds the potential to effectively treat multiple autoimmune diseases by targeting fAABs as their root cause.
“With the inclusion of patients in the clinical Phase II trial in Long Covid, we are jointly taking the next important step to advance the development of BC 007.”