Phase II Milestone Reached: Berlin Cures' Screening for Long COVID Therapy BC 007 Complete

Berlin Cures, a leading clinical-stage biotech firm, has reported a milestone in its pan-European Phase II trial for BC 007 (Rovunaptabin), a potential treatment for Long COVID. The trial has reached its full capacity, enrolling the intended number of participants, which is a significant advancement in the company's mission to aid millions affected by the condition. The trial is advancing to subsequent stages and is on track to deliver initial results by the fall of 2024.

The study has enrolled over 114 individuals across 14 centers in Finland, Germany, Austria, Switzerland, and Spain. With the screening phase complete, no further applications are being accepted as all slots are filled.

Oliver von Stein, the CEO of Berlin Cures, has voiced his approval of the trial's swift progress, highlighting the urgent demand for an effective Long COVID treatment. He emphasized the company's dedication to scientific rigor and its aim to develop a treatment that can markedly enhance patient outcomes. The company anticipates that the upcoming results will bring a significant step forward in combating Long COVID.

Berlin Cures is pioneering the development of aptamer-based drugs designed to neutralize pathogenic functional autoantibodies (fAABs) that are linked to various autoimmune diseases, including Long COVID, heart failure, glaucoma, ME/CFS, and more. The drug candidate BC 007 is designed to target these harmful fAABs, which are thought to be central to the symptoms of Long COVID.

With the trial now fully recruited, Berlin Cures is gearing up for the Phase III study, crucial for regulatory approval and market introduction of BC 007. The firm is currently seeking financial partners to initiate Phase III promptly after the successful conclusion of Phase II.

The Berlin Cures team has spent over two decades researching functional autoantibodies (fAABs) and has identified a molecule that can effectively neutralize them. Encouraging preclinical results have been observed for BC 007, particularly in a Phase IIa trial with chronic heart failure patients, where a single dose led to long-term autoantibody neutralization and significant cardiac function improvement. The drug's potential for treating Long COVID was confirmed through positive tests for fAABs in sera from Long COVID patients, corroborated by clinical observations in four case studies. Berlin Cures stands as a pioneering entity in addressing fAAB-associated diseases at their root with its unique biotechnology.

Since June 2023, Berlin Cures has been conducting a Phase II clinical trial with BC 007 for Long COVID, a pressing and growing global health concern, to obtain substantial results on the drug's efficacy and tolerability in Long COVID patients.