FIRST EVER PATIENT DOSED WITH ALPIBECTIR-ETHIONAMIDE IN COMBINATION WITH FIRST-LINE TB DRUGS IN A 14-DAY PHASE 2 CLINICAL TRIAL

Ad hoc announcement pursuant to Art. 53 LR

Basel, Switzerland. March 19, 2025, 7am CET.  Ad hoc announcement pursuant to Art. 53 LR

• Under the BioVersys and GSK collaboration agreement, GSK is evaluating the early bactericidal activity (EBA) of alpibectir-ethionamide (AlpE) in a pulmonary tuberculosis (TB) trial, in combination with first-line TB drugs.
• Development of AlpE is strongly supported by European Union and European Pharmaceutical Industry through UNITE4TB, an Innovative Medicines Initiative (IMI2) Joint Undertaking.
• The EBA trial is expected to enroll 60 pulmonary TB patients and run untill end of 2025.
• Topline data readout by Q2 2026.

BioVersys AG (SIX: BIOV), a multi-asset, clinical stage biopharmaceutical company focusing on research and development of novel antibacterial products for serious life-threatening infections caused by multidrug-resistant (MDR) bacteria, announced today, that the first patient has been dosed in a pulmonary TB Phase 2 clinical trial, evaluating the early bactericidal activity (EBA) and safety of alpibectir-ethionamide (AlpE) in combination with first-line TB drugs for the first time. The study is being conducted under the European Union’s IMI2 UNITE4TB project.

Through UNITE4TB, AlpE is being studied for the first time in a 14-day EBA clinical trial in combination with first-line TB drugs, marking a significant step forward in the further development of this unique combination. Through this Phase 2 TB drug combination trial, BioVersys and its partner GSK seek to get further insights of the potential impact of AlpE in TB patient’ treatments. Under the GSK-BioVersys collaboration agreement, GSK is responsible for developing AlpE for pulmonary indications and BioVersys is addressing TB meningitis (TBM), with BioVersys targeting the start of a TMB trial in H1-2026. This collaborative, two-pronged approach of BioVersys and GSK with their clinical trials partner TASK, aims to expedite the development of AlpE to TB patients.

Alpibectir (also known as BVL-GSK098) is a small molecule developed from BioVersys’ award winning Transcriptional Regulatory Inhibitory Compounds (TRIC) platform in a successful collaboration with GSK, the Institut Pasteur Lille and the University of Lille. The compound represents a novel concept to overcome resistance and significantly potentiate the activity of an existing antibiotic, ethionamide (Eto) or prothionamide (Pto), for the treatment of TB. In 2023 the fixed-dose combination of AlpE was granted orphan-drug designation (ODD) for the treatment of tuberculosis, by the U.S. Food and Drug Administration (U.S. FDA).

Dr. Glenn E. Dale, Chief Development Officer of BioVersys: “Alpibectir has shown a very promising safety profile and to be well tolerated, in both a Phase 1 and a 7-day EBA Phase 2a study, in which the AlpE combination delivered a first human proof of concept, with bactericidal activity similar to isoniazid in patients with tuberculosis. Based on these very promising data we are excited to study AlpE in a second Phase 2 EBA study, this time testing the efficacy, safety, tolerability and pharmacokinetics over a 14-day period and importantly in combination with first-line TB drugs.”

Prof. Andreas Diacon, Founder and Chief Scientific Officer at TASK and WP4 Lead in UNITE4TB: “Following the highly successful Phase 2a study, we are delighted to continue collaborating with GSK and BioVersys to advance AlpE. The drug combination demonstrated activity and tolerability comparable to isoniazid, a potent agent against tuberculosis. This extended study aims to optimize AlpE usage and to assess its potential as a replacement for isoniazid when administered in conjunction with established antibiotics.”

David Barros-Aguirre Head of Global Health Medicines R&D, GSK and UNITE4TB Project Lead: “Tuberculosis (TB) remains a public health threat, disproportionately affecting vulnerable communities in high-burden countries around the world. The start of the Phase 2a clinical trial with alpibectir-ethionamide (AlpE), in combination with first-line TB drugs, signals an important step forward to combat drug resistant TB. Through our longstanding partnership with BioVersys, and UNITE4TB, we are working to change the trajectory of the TB epidemic.”

Dr. Marc Gitzinger, Chief Executive Officer and founder of BioVersys: “Tuberculosis remains the largest infectious disease killer in the world and is far from being eradicated. Our partnership with GSK, to advance the development of alpibectir to reach patients in need, combined with the continued public sector support from the EU IHI UNITE4TB program, shows how public-private partnerships can work on delivering solutions for global health. We are excited to continue the development of alpibectir in pulmonary TB and in parallel, at BioVersys, we are also preparing for a first study in TB meningitis patients.”

About tuberculosis (TB) 
Tuberculosis (TB) is one of the leading causes of death worldwide. Its causative agent is the bacterial pathogen Mycobacterium tuberculosis (Mtb). According to the latest 2024 WHO TB report, worldwide an estimated 10.8 million people developed TB in 2023 and an estimated 1.25 million died from TB. WHO estimates that there were 400’000 new cases with resistance to rifampicin, most of them were multi-drug resistant (MDR). MDR-TB remains a public health crisis and a health security threat. Worldwide, only 68% 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 were recorded in eight countries: India (26%), Indonesia (10%), China (6.8%), the Philippines (6.8%), Pakistan (6.3%), Nigeria (4.6%), Bangladesh (3.5%) and the Democratic Republic of the Congo (3.1%). Furthermore, 3.2% of all new and 16% of reoccurring TB cases were MDR/RR-TB.

About UNITE4TB
UNITE4TB is one of nine projects within the AMR Accelerator. Working across a global clinical trials network, UNITE4TB conducts regulatory standard Phase 2 clinical trials to accelerate clinical evaluation of novel drugs and combinations of drugs for tuberculosis (TB). Innovative adaptive trial designs, treatment response biomarkers, pharmacokinetic-pharmacodynamic models and Artificial Intelligence / Deep Learning techniques are integrated across study protocols, deploying cutting-edge methodologies to find antibiotic regimens with the highest likelihood of improved clinical efficacy. 
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 101007873. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA, Deutsches Zentrum für Infektionsforschung e.V. (DZIF), and Ludwig-Maximilians-Universität München (LMU). EFPIA/AP contribute 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.

About ENABLE
The ENABLE study will evaluate the 14 day EBA, safety, tolerability and dose-response of AlpE and AlpE with rifampicin (R), pyrazinamide (Z), and ethambutol (E) in adults with newly diagnosed, drug-susceptible pulmonary TB. The over-arching objective is to optimise the dose of AlpE and to evaluate the safety of the AlpE+RZE regimen for future evaluation as an alternative regimen for isoniazid mono-resistant TB. The data from the ENABLE study and the bEto study (NCT05473195) will support the evaluation of the optimal dose combination of AlpE to move forward into late phase studies. 

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 TASK
TASK is a global clinical research organization dedicated to advancing healthcare through innovative and ethical clinical trials. Our experienced scientists, clinicians, and regulatory experts deliver high-quality clinical research solutions that accelerate drug discovery and improve patient outcomes. Over the last 20 years TASK has completed more than 140 research projects in different therapeutic areas and contributed to progressing the scientific field of TB medicine and vaccine development, most notably with early bactericidal activity (EBA) studies and clinical trials that in part led to the registration of bedaquiline. Find us at https://taskclinical.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 3 ready), 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. 

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¹ Global tuberculosis report 2024. Geneva: World Health Organization; 2024. Licence: CC BY-NC-SA 3.0 IGO.
 

BioVersys contact 
Hernan Levett, CFO, Tel. +41 61 633 22 50; Mail: hernan.levett@bioversys.com
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