Recruitment completed: Berlin Cures achieves key milestone in BC 007 Phase II Trial for treatment of Long COVID
Berlin, Germany, 23 April 2024
Berlin Cures, a pioneering clinical-stage biotechnology company, today announced the successful completion of patient recruitment for its pan-European Phase II trial of BC 007 (Rovunaptabin), a novel therapeutic candidate for the treatment of Long COVID. The study has now recruited its target number of participants, marking a significant step forward in the company's pursuit to help millions of people suffering from Long COVID. The trial is progressing rapidly into its next clinical stages and remains firmly on schedule, with first results anticipated by autumn 2024.
More than 114 patients across 14 trial centers in Finland,
Germany, Austria, Switzerland, and Spain have now been enrolled.
With the completion of the recruitment process, patients are
asked to refrain from submitting further applications, as all
available places in the study have been filled.
Oliver von Stein, CEO of Berlin Cures,
expressed his satisfaction with the trial's progress: "The
completion of recruitment in such a short period of time
demonstrates the great need for an effective therapy for Long
COVID. This achievement reflects our commitment to rigorous
scientific processes and our dedication to developing a
treatment that can significantly improve patient outcomes. We
look forward to the forthcoming results, which we believe will
bring us closer to a major breakthrough in the fight against
Long COVID."
Berlin Cures is at the forefront of
developing innovative aptamer-based drugs to neutralize
pathogenic functional autoantibodies (fAABs) that contribute to
a variety of autoimmune diseases, including Long COVID, heart
failure, glaucoma, ME/CFS and many more. The drug candidate BC
007 targets these harmful fAABs, which are believed to play a
critical role in the symptoms associated with Long COVID.
With
the trial fully recruited, Berlin Cures is actively preparing
for the subsequent Phase III study, which will be essential for
gaining regulatory approval and bringing BC 007 to market. The
company is currently actively seeking funding partners to
initiate Phase III as soon as possible following the successful
completion of Phase II.
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. In
a recently completed Phase IIa trial with patients with chronic
heart failure, BC 007 demonstrated long-term autoantibody
neutralization after a single dose resulting in significant
improvement in cardiac function, with no spontaneous
disappearance of autoantibodies in untreated patients. Its
potential as an effective therapy for Long COVID was realized
when tests on sera from Long COVID patients proved positive for
fAABs, supported by clinical observations in four case studies.
By addressing the underlying cause of fAAB-associated diseases
with this unique biotechnology, Berlin Cures emerges as one of
the pioneering entities committed to addressing this critical
issue at its core.
Since June 2023, Berlin Cures has
been 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.
