Berlin Cures starts Long COVID Phase II Trial – first patients admitted.

The start of the Phase II clinical trial marks an important milestone in the further development of Berlin Cures’ lead drug candidate BC 007. The substance functions similarly to an antibody, binding and neutralizing harmful fAABs. Thereby it can potentially cure the root cause of different autoimmune diseases. The current clinical trial will provide meaningful and robust results on the efficacy and tolerability of BC 007 in patients suffering from Long COVID. If positive results are obtained, it will provide the necessary basis for a larger Phase III study that is required for the approval of BC 007. First results of the Phase II trial are expected in early 2024.

Berlin Cures today also welcomes Dr. Axel Mescheder as its new Chief Medical Officer (CMO). With more than 30 years of experience in the industry, Dr. Mescheder will be responsible for the clinical development of BC 007.

“We are delighted to welcome Dr. Axel Mescheder at this important time,” said Oliver von Stein, CEO of Berlin Cures. “As CMO, he will be a driving force behind Berlin Cures’ efforts to bring relief and a cure to patients suffering from fAAB-associated diseases. Together, we will work towards transforming our platform technology into a therapeutic solution for millions of patients.”

Dr. Axel Mescheder has a successful track record of more than 30 years in the pharmaceutical, CRO and biotechnology industry. He previously held various senior management and C-level positions at SynOx Therapeutics, Medpace and TopoTarget and was responsible for several clinical development programs leading to successful product registrations or label extensions in both Europe and the United States. Dr. Mescheder is a board-certified M.D. from the University of Kiel (Germany), with a medical license and full specialization in Pharmacology and Toxicology.

“Berlin Cures’ platform technology holds the potential to effectively treat multiple autoimmune diseases by targeting fAABs as their root cause. I am honored to support Berlin Cures in this promising endeavor in my new role as Chief Medical Officer,” said Dr. Axel Mescheder. “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.”

About Berlin Cures:
The Berlin Cures team has dedicated over two decades to the research of functional autoantibodies (fAABs) and has successfully identified a molecule capable of effectively neutralizing these. Promising preclinical results have been observed for BC 007. It was found effective in fAAB-positive healthy volunteers during the Phase I study and in heart failure patients in a Phase IIa trial. Its potential against Long COVID is indicated by lab data generated using sera from Long COVID patients, and four case studies. By potentially tackling the root cause of fAAB-associated diseases, this platform biotechnology signifies a pioneering approach in therapeutics. With this unique biotechnology, Berlin Cures emerges as one of the pioneering entities committed to addressing this critical issue at its core.

Starting in June 2023, Berlin Cures is absolving a Phase II clinical trial with BC 007 in the indication Long COVID, an acute and escalating global health problem, to obtain meaningful and robust results on efficacy and tolerability of BC 007 with patients suffering from Long COVID.