BioVersys, a clinical stage biopharmaceutical company from Basel, has received orphan-drug designation from the U.S. Food and Drug Administration for its novel treatment against tuberculosis. This designation comes with benefits for the ongoing Phase 2a clinical trial of the lead candidate alpibectir in the context of the bEto-TB Project.
Tuberculosis (TB) is one of the leading causes of death by infectious disease globally, with the WHO estimating that 10.6 million people fell ill with TB worldwide in 2022. TB is present in all countries and age groups and existing treatments are becoming less effective due to an increase in drug resistance, resulting in an immense public health threat. BioVersys, a biopharmaceutical startup focusing on novel antibacterial drugs against life-threatening infections, caused by multi drug resistant (MDR) bacteria, has so far developed clinical drug candidates addressing nosocomial infections of Acinetobacter baumannii, and infections of Mycobacterium tuberculosis.
Among BioVersys’ clinical drug candidates is alpibectir (BVL-GSK098), a small molecule that can significantly potentiate the activity of an existing antibiotic against (MDR) tuberculosis bacteria - ethionamide (Eto) - while simultaneously reducing Eto resistance. As a Transcriptional Regulator Inhibitory Compound (TRIC), alpibectir has this beneficial effect on Eto through a novel mode of action. The combinational treatment (alpibectir plus ethionamide) was developed in a successful public-private collaboration with GSK, Pasteur Institute Lille and the University of Lille and is currently in a Phase 2a proof-of-concept study in pulmonary TB patients, which is being conducted in South Africa with TASK. In the context of this development, the bEto-TB project was initiated, as a consortium with the goals to determine the early bactericidal activity (EBA) of the combination of alpibectir and various doses of Eto. Based on pre-clinical data, it is expected that alpibectir could lower the efficacious human oral dose of Eto by at least 3-fold, with the potential to significantly reduce dose-dependent side effects and improve patient compliance.
The U.S. Food and Drug Administration (FDA) now granted BioVersys orphan-drug designation (ODD) for alpibectir. This designation can be given to pharmaceutical products and drugs that target rare diseases. In the context of this ODD, BioVersys is qualified for benefits including tax credits for qualified clinical trials, exemption from user fees, potentially seven years of market exclusivity after approval. Thus, the ODD will further boost the bEto-TB Project, currently in Phase 2a of clinical trials, which is also supported by EU IMI-JU2 programme under the AMR Accelerator umbrella and from the European & Developing Countries Clinical Trials Partnership (EDCTP2 programme).
(SR / press release)
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