BC 007 Advances in Phase II Trial: More Than Half of Long COVID Patients Enrolled

A German clinical-stage biotechnology company, Berlin Cures, is making strides in the development of a novel treatment for Long COVID, a condition affecting an estimated 100 million individuals globally. The company has successfully recruited over half of the intended 114 participants for its Phase II clinical trial and has broadened the criteria for study inclusion. This trial is centered around BC 007, a drug candidate designed to neutralize functional autoantibodies (fAABs), which are believed to be instrumental in the ongoing symptoms of Long COVID.

The research is being conducted across 12 trial sites in Finland, Germany, Austria, Switzerland, and Spain, highlighting a collaborative approach to tackling a significant health challenge. The study is on track, with plans for seven additional centers to join the effort. Berlin Cures anticipates revealing the trial's results in the fall of 2024, which will be instrumental in advancing the drug to Phase III, a critical step toward regulatory approval.

Dr. Oliver von Stein, the CEO of Berlin Cures, underscores the urgency of addressing Long COVID, which has become a global health crisis impacting lives and economies. He emphasizes the importance of immediate action to prevent escalating healthcare costs and social disparities. Berlin Cures is at the vanguard of creating innovative therapies for autoimmune diseases, with BC 007 being a prime example of its commitment to targeting fAABs implicated in various conditions, including Long COVID.

The ongoing Phase II trial is expected to provide definitive evidence of BC 007's efficacy and safety. The company is optimistic about the results and is already seeking the necessary funding to proceed with Phase III, which is essential for the drug's eventual approval.

Functional autoantibodies are detectable in approximately 40% of Long COVID patients and can lead to autoimmune diseases by mistakenly targeting the body's own tissues or cells. BC 007 has the potential to treat a substantial number of individuals suffering from Long COVID by addressing the root cause of their symptoms. Berlin Cures is steadfast in its mission to find a cure for fAAB-induced diseases, relying on private funding since its establishment.

BC 007 is not limited to treating Long COVID; it is a versatile platform technology with the potential to combat multiple fAAB-associated diseases. Berlin Cures has built this drug on over two decades of fAAB research. The drug has shown promise in Phase I studies with fAAB-positive volunteers and in a Phase IIa trial with heart failure patients, where it demonstrated long-term benefits and was well-tolerated.

Berlin Cures has been conducting a Phase II clinical trial with BC 007 for Long COVID since June 2023, aiming to achieve robust results on the drug's efficacy and safety. The company continues to seek additional investments and partnerships to further this groundbreaking research.