News
December 12, 2023
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 receives U.S. FDA orphan-drug designation for alpibectir and ethionamide fixed-dose combination for treatment of tuberculosis
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).
About TRIC-TB Project
Ethionamide (Eto) and prothionamide (Pto) are recommended by the World Health Organization (WHO) for use as second-line agents in the treatment of drug-resistant pulmonary TB and TB meningitis. Despite their usefulness as TB drugs, Eto/Pto cause dose-dependent adverse events that negatively impact treatment adherence. Eto/Pto are prodrugs and their antibacterial activity can be linked to the level of bioactivation inside Mycobacterium tuberculosis (Mtb). The clinical candidate alpibectir (formerly BVL-GSK098) acts on transcriptional regulators of Mtb, stimulating novel bioactivation pathways for Eto resulting in an increase of Eto efficacy, while simultaneously overcoming Eto resistance and keeping potent activity on MDR strains, including to a vast majority of isoniazid-resistant strains. BVL-GSK098 renders Eto rapidly bactericidal and reduces the emergence of Eto resistance development in vitro and in vivo. Based on pre-clinical data, it is expected that BVL-GSK098 could lower the efficacious human oral dose of Eto by at least 3-fold, with the potential to significantly minimize dose-dependent side effects and improve patient compliance allowing to finally tap into the full potential of this 60 year old drug. TRIC-TB has the potential to deliver a novel, fast acting TB agent potentially replacing isoniazid in TB therapy. With the completion of Phase 1 a major milestone of the TRIC-TB Project was achieved. Follow TRIC-TB on Twitter @TRIC_TB.
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 853800. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EPFIA.
About bEto-TB Project
This project brings a new anti-TB molecule, BVL-GSK098, to the current drug armamentarium. BVL-GSK098 greatly augments the activity of, and overcomes resistance to, the well-established second line drug Eto at a lower and well-tolerated dose. The objectives of this consortium are to determine the early bactericidal activity (EBA) of the combination of BVL-GSK098 and various doses of Eto. We will also evaluate the comparative anti-TB activity of bEto to that of standard dose INH and thus explore the potential for bEto as a replacement of INH in the current first-line regimen or to add a novel bactericidal drug to future regimens. The project has previously received funding from the EU IMI 2 JU (TRIC-TB) and the Wellcome Trust.
Project description website: https://www.task.org.za/beto/ Twitter
The bEto-TB Project (grant reference: RIA2019AMR-2657) is part of the EDCTP2 programme supported by the European Union.
Statements or views expressed in this release are of those of the respective organizations or persons and the IMI2 JU and the European & Developing Countries Clinical Trials Partnership are not responsible for any use of the information contained herein.
About tuberculosis (TB)
Tuberculosis (TB) is one of the leading causes of death worldwide. Its causative agent is the bacterial pathogen Mycobacterium tuberculosis (Mtb). Worldwide, an estimated 10.6 million people developed TB in 2022 and an estimated 1.30 million died from TB. WHO estimates that there were 410’000 new cases with resistance to rifampicin – the most effective first-line drug – most of them were multi-drug resistant (MDR) MDR-TB remains a public health crisis and a health security threat. Worldwide, only 63% of MDR-TB patients are currently successfully treated.[1] In the modern world of global travel, and ease with which infections spread, it is very worrying to note that two-thirds of the global total of TB cases was in eight countries: India (27%), Indonesia (10%), China (7.1%), the Philippines (7.0%), Pakistan (5.7%), Nigeria (4.5%), Bangladesh (3.6%) and the Democratic Republic of the Congo (3.0%). Furthermore, 3.3% of all new and 17% of reoccurring TB cases were MDR/RR-TB.
About U.S. FDA orphan-drug designation (ODD)
U.S. FDA orphan-drug designation qualifies sponsors for incentives including, tax credits for qualified clinical trials, exemption from user fees and potential seven years of market exclusivity after approval. See: Designating an Orphan Product: Drugs and Biological Products | FDA.
About the Innovative Medicines Initiative
The Innovative Medicines Initiative (IMI) IMI is a partnership between the European Union and the European pharmaceutical industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA). It was set up to improve health by speeding up the development of, and patient access to, the next generation of medicines, particularly in areas where there is an unmet medical or social need. It works by facilitating collaboration between the key players involved in healthcare research, including universities, pharmaceutical companies, other companies active in healthcare research, small and medium-sized enterprises (SMEs), patient organisations, and medicines regulators. This approach has proven highly successful, and IMI projects are delivering exciting results that are helping to advance the development of urgently-needed new treatments in diverse areas. IMI projects are now managed by the Innovative Health Initiative (IHI), which builds on the successes of IMI and is a cross-sectoral public-private partnership involving a wider range of health industries.
- More info on IHI: https://www.ihi.europa.eu/
- Twitter: @IHIEurope
- More info on IMI AMR accelerator: https://amr-accelerator.eu/project/tric-tb/
- Working Group of new TB drugs: https://www.newtbdrugs.org/pipeline/compound/bvl-gsk098
About the European & Developing Countries Clinical Trials Partnership (EDCTP)
The mission of the EDCTP is to contribute to the reduction of the individual, social, and economic burden of poverty-related infectious diseases in sub-Saharan Africa. EDCTP funds collaborative clinical research that accelerates the development of accessible, suitable, and affordable medical interventions (drugs, vaccines, microbicides, and diagnostics) to identify, prevent or treat infectious diseases. EDCTP has prioritized HIV, tuberculosis (TB) and malaria research, while also contributing to clinical developments for diarrhoeal diseases, lower respiratory tract infections and emerging or re-emerging infectious diseases of particular relevance for Africa, such as Ebola and yellow fever.
About GSK
GSK is a science-led global healthcare company. For further information please visit https://www.gsk.com/en-gb/about-us/
About BioVersys
BioVersys AG is a multi-asset, clinical stage biopharmaceutical company focused on identifying, developing and commercializing novel antibacterial products for serious life-threatening infections caused by multi-drug resistant (“MDR”) bacteria. Derived from the company’s two internal technology platforms (TRIC and Ansamycin Chemistry), candidates are designed and developed to overcome resistance mechanisms, block virulence production and directly affect the pathogenesis of harmful bacteria towards the identification of new treatment options in the antimicrobial and microbiome fields. This enables BioVersys to address the high unmet medical need for new treatments against life-threatening resistant bacterial infections and bacteria-exacerbated chronic inflammatory microbiome disorders. The company’s most advanced research and development programs address nosocomial infections of Acinetobacter baumannii (BV100, Phase 2), and tuberculosis (alpibectir, Phase 2a, in collaboration with GlaxoSmithKline (GSK) and a consortium of the University of Lille, France). BioVersys is located in the biotech hub of Basel, Switzerland.
BioVersys contact
Sylvia Mundt, Executive Assistant to CEO, Tel. +41 61 633 22 50 ; Mail : IR@bioversys.com
Website : https://www.bioversys.com/ Twitter LinkedIn