NEWS | BEAM Alliance


BioVersys receives U.S. FDA orphan-drug designation for alpibectir and ethionamide fixed-dose combination for treatment of tuberculosis

Basel, Switzerland. December 12, 2023, 9am CET

BioVersys AG, a multi-asset, clinical stage biopharmaceutical company focusing on research and development of novel antibacterial products for serious life-threatening infections caused by multi-drug resistant (“MDR”) bacteria, announced today that the U.S. Food and Drug Administration (U.S. FDA) has granted orphan-drug designation (ODD) to alpibectir (BVL-GSK098) and ethionamide fixed-dose combination for treatment of tuberculosis (TB).

Tuberculosis is one of the leading causes of death by infectious disease globally, and many existing treatments are becoming less effective due to growing drug resistance. Alpibectir, a small molecule acting through a novel mode of action, represents a totally new concept of overcoming resistance by significantly potentiating the activity of an existing antibiotic, ethionamide (Eto). It is being developed for pulmonary and meningeal TB.

The FDA’s orphan-drug designation reflects the urgent need for more research into ways to overcome resistance to TB medicines, and the potential for alpibectir and ethionamide fixed-dose combination to improve treatment options for patients who have TB. Alpibectir 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.

Dr. Marc Gitzinger, Chief Executive Officer and founder of BioVersys: “This U.S. FDA ODD is a great qualification of our development approach to deliver urgently needed therapeutic solutions for the highest unmet medical needs. TB patients are underserved, with inadequate therapies that lead to long treatment times and unacceptably high mortality, particularly when compared to other infectious disease indications. We are particularly pleased that this effort to redress the imbalance in treating TB patients is being served by a public-private partnership.”

Dr. David Barros-Aguirre, VP and Head of Global Health Medicines R&D Unit, Global Health R&D, GSK: “We are delighted to partner with BioVersys on the development of alpibectir for TB. The FDA ODD is another important step towards reducing the impact of drug resistance on effective treatment for people with TB. This joint effort is one more example of GSK working closely with partners to bring medicines and vaccines designed to address unmet need in global health to the people who need them.”

The TRIC-TB Project continues to receive funding from the EU IMI-JU2 programme under the AMR Accelerator umbrella and from the European & Developing Countries Clinical Trials Partnership (EDCTP2 programme) for the bEto-TB Project (Phase 2a).

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