Rovunaptabin (formally BC 007) binds to autoantibodies that target G protein-coupled receptors in the body and neutralizes them. Such antibodies occur in various diseases, including post-COVID syndrome (PCS) – but not in all patients. The drug was developed by the Berlin-based start-up Berlin Cures. An initial case study from 2021 showed that patients with PCS can benefit significantly from the treatment. However, in a Phase II trial (BLOC) in 2024, topline results indicated that the drug was not superior to a placebo. Following this outcome the company filed for insolvency.
However, scientists at the Eye Clinic of Erlangen University Hospital, who are researching the pathomechanisms of glaucoma, were not discouraged by the negative results. They are interested in the active ingredient because such autoantibodies are also detectable in glaucoma patients.
The researchers tested rovunaptabin in 30 selected patients with PCS. The results of reCOVer, an investigator initiated noncontrolled Phase IIa clinical study, are published in the journal eClinicalMedicine. The study only included PCS patients in whom various variants of functional autoantibodies against G protein-coupled receptors were detectable. These autoantibodies are considered a pathogenic factor in PCS patients, who suffer primarily from pronounced fatigue, a very debilitating, permanent exhaustion. The data show that these patients experienced significant improvements in their long COVID symptoms and suggest further clinical studies to be performed in order to confirm the findings in a larger cohort.
The recently founded clinical stage biopharmaceutical company APTA Therapeutics, led by the former CEO of Berlin Cures, Dr. Oliver von Stein, has acquired the rights to rovunaptabin and now intends to continue its clinical development, taking into account the findings from the BLOC study and placing a stronger focus on identifying the patients most likely to respond to the drug. The company will collaborate with leading medical experts, renowned clinical centers and national and international medical institutes, to bring rovunapatabin towards a registration phase III study required for market approval.
Long COVID affects around 6–7% of the adult population worldwide. It is an umbrella term for a group of conditions with different symptom patterns that occur as a result of COVID-19 infection. Scientists agree that there will be no universal cure.
APTA Therapeutics traces its scientific roots to two of Berlin’s most prestigious research institutions: Charité – Universitätsmedizin Berlin and the Max Delbrück Center for Molecular Medicine. Ascenion, as the technology transfer partner of Charité and the Max Delbrück Center, has accompanied APTA Therapeutics from the beginning and supported the negotiations on the license agreement with both partner institutes.
Further information: website of APTA Therapeutics
