News
September 24, 2024
NATURE REVIEWS HIGHLIGHTS SIGNIFICANT SUCCESSES OF ANTIBIOTIC COLLABORATION AND CALLS FOR SUSTAINABLE R&D FUNDING SCHEMES
Basel, Switzerland. September 24, 2024, 7am CEST
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, in collaboration with its partners in the AMR Accelerator programme, call for sustainable investment in antimicrobial research and development.
Antibiotic resistance is a threat to modern healthcare. Nine European research projects have published in Nature Reviews Drug Discovery an article emphasizing the need to maintain expertise and capability for developing new treatments for infectious diseases, such as those exemplified in the successful European Union’s IMI2 funded TRIC-TB programme.
TRIC-TB, successfully reached key milestones, delivering a Phase 2-ready tuberculosis clinical candidate, alpibectir, that is being jointly developed by BioVersys and GSK. The funding that BioVersys as the product developer received, enabled the translation of this exciting new TB therapy into Phase 2a in patients in South Africa. This program now seeks funding to address deadly TB meningitis infections, which predominantly and severely affect children.
Together, the nine projects of the AMR Accelerator call on government leaders, the private sector and other stakeholders to invest in the development of new antibiotics and research on antimicrobial resistance (AMR), to secure a sustainable future for large-scale efforts.
Dr. Marc Gitzinger, Chief Executive Officer and founder of BioVersys: “The continued innovation for developing new antibiotics fighting AMR is crucial for modern medicine, in high- and low-income countries. There is simply no way around appropriate funding and market incentives for new antibiotics. Efforts led by the European Union, such as the IMI2 programme should continue and be expanded. However, even more important is to act on adequate reimbursement mechanisms for antibiotics, which are life-saving medicines. We hope that successful projects like TRIC-TB demonstrate the success that adequate funding can deliver.”
Dr. David Barros-Aguirre, VP and Head of Global Health Medicines R&D Unit, Global Health R&D, GSK: “Now more than ever, there is a need for sustainable funding mechanisms to combat antimicrobial resistance (AMR), which disproportionately impacts people living in lower income countries. We have witnessed the positive impact of pooled procurement mechanisms in supporting equitable access to new vaccines, building resilience into supply chains and contributing to the development of healthy markets. Yet, these mechanisms do not currently exist for many AMR innovative treatment opportunities.”
Antimicrobial resistance is recognised as one of the greatest global challenges of our time, undermining healthcare systems that rely heavily on antibiotics to prevent and treat infections. The need for new antibiotics is well-recognized, and on 26 September, the United Nations General Assembly will spotlight this issue in a high-level meeting on AMR. However, the low return on investment in this area has caused many large pharmaceutical companies to leave the field. This has led to a decline in the rate of development of new drugs and therapies for bacterial infections.
The broad scope sets the AMR Accelerator apart from other large-scale efforts: the projects have received funding from the European Commission via the Innovative Medicines Initiative (IMI) and pharmaceutical companies that are members of EFPIA. With a total budget of €479 million, the AMR Accelerator has progressed 44 antibacterial programmes over the past 5 years. So far, the effort has resulted in 16 preclinical and clinical candidates, two completed Phase 1 studies, and five ongoing Phase 1 and 2 studies. The continuing success of the AMR Accelerator demonstrates the value of public-private partnerships, replenishing the antibiotics pipeline and providing tools and infrastructure for the global research community.
“In TRIC-TB, we combined an agile, fast-moving SME (BioVersys) with the experience and capabilities of a big industry partner (GSK), to develop an anti-TB drug with an entirely new concept. The small consortium size allowed us to move with speed and agility. In 3½ years TRIC-TB completed CTA-enabling and Phase 1 studies allowing the start of a Phase 2a trial despite the impact of the COVID-19 pandemic”, says Michel Pieren, the TRIC-TB project coordinator, from BioVersys.
The AMR Accelerator has created critical mass and synergies that have allowed the transfer of assets, knowledge, and expertise between projects. The results are tangible: better and more efficient science, a strengthening of the antibiotic pipeline, and a legacy of research infrastructures that can support the global fight against antibiotic resistance: these include, standardized infection models, non-clinical assays, clinical trial protocols and regulatory compliant processes. However, the key challenge for all nine projects is to ensure the long-term sustainability of assets, infrastructures and expertise. Which in turn requires a commitment from governments and the pharmaceutical industry to long-term investment in antimicrobial research and antibiotics development.
Read the article: https://www.nature.com/articles/d41573-024-00138-9 and DOI: 10.1038/d41573-024-00138-9
About the AMR Accelerator
AMR Accelerator programme was launched in 2019, with the aim to accelerate the development of medicines for patients suffering from infections with drug-resistant Mycobacterium tuberculosis, Nontuberculous mycobacteria (NTM), and Gram-negative bacteria, and build capability for antibiotics research and development. The programme is funded by the Innovative Medicines Initiative (IMI). The AMR Accelerator programme includes nine projects: AB-Direct, COMBINE, ERA4TB, GNA NOW, PriMAVeRa, RespiriNTM & RespiriTB, TRIC-TB, and UNITE4TB. Together, the projects have a €479 million budget. The 98 partners represent key stakeholders from academia, industry, small- and medium-sized companies, patient organisations, regulators, and Health Technology Assessment.
IMI projects are public-private partnerships, funded in equal parts by the European Union’s Horizon 2020-programme and the pharmaceutical companies that are members of EFPIA.
More information: www.amr-accelerator.eu
AMR Accelerator portfolio: https://amr-accelerator.eu/amr-accelerator-project-portfolio/
The AMR Accelerator has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under Grant Agreements No 853967 I 853989 I 853979 I 853932 I 853800 I 853903 I 853976 I 101007873 I 101034420. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. ERA4TB receives additional support from Global Alliance for TB Drug Development, Bill & Melinda Gates Foundation and University of Dundee. UNITE4TB receives additional support from Deutsches Zentrum für Infektionsforschung e. V. (DZIF), and Ludwig-Maximilians-Universität München (LMU). EFPIA/AP contribute to 50% of funding, whereas the contribution of DZIF and the LMU University Hospital Munich has been granted by the German Federal Ministry of Education and Research.
Disclaimer: This text reflects the author’s view. Neither IMI nor the European Union, EFPIA or any other third parties are responsible for any use that may be made of the information contained herein.
The COMBINE project has a coordinating role in the AMR Accelerator programme. For more information, please contact Anders Karlén, Professor of Computer-Aided Drug Design, Uppsala University & project coordinator, COMBINE. E-mail: anders.karlen@uu.se or Marie Olliver, Alliance manager COMBINE, Uppsala University. E-mail: marie.olliver@uu.se.
About TRIC-TB
TRIC-TB successfully completed the Phase 1 study with alpibectir (BVL-GSK098), a small molecule potentiating the activity of ethionamide. It is hoped alpibectir would allow lower doses of ethionamide thus minimizing dose-dependent side effects and, it is hoped, improving patient compliance. In laboratory tests, the combination of alpibectir/ethionamide (AlpE) is rapidly bactericidal, overcomes MDR and Eto-resistance, and shows the potential to become an important building block in novel regimens in TB endemic countries. AlpE is currently tested in a Phase 2a proof-of-concept study (NCT05473195).
TRIC-TB has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under Grant Agreement No 853800. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA companies’ in-kind contribution.
For more information, please contact Michel Pieren, Clinical Program Team Leader, BioVersys & TRIC-TB project coordinator. E-mail: michel.pieren@bioversys.com
About GSK
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com
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: www.bioversys.com