• Under the BioVersys and GSK collaboration agreement, AlpE clinical development advances with first patient dosed in Phase 2b trial within UNITE4TB, following completion of a Phase 2a in adults with drug-susceptible pulmonary TB (DS-TB) in combination with RZE.[1]
• In the new Phase 2b trial in adults with DS-TB, AlpE will be dosed for two months together with RZE, patients then continue only with RH[2] for 18 weeks.
• Phase 2b results are expected by the end of 2027.
• In addition, BioVersys plans to initiate a Phase 2 trial in TB meningitis in H1 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 multi-drug resistant (MDR) bacteria, announced today, that the first patient has been dosed in a  pulmonary TB Phase 2b clinical trial, evaluating the efficacy, safety and pharmacokinetics of alpibectir-ethionamide (AlpE) in combination with first-line TB drugs (NCT05807399).

In this new Phase 2b trial, a portion of the recruited adults with drug sensitive pulmonary tuberculosis (DS-TB) will be dosed for 2-months with RZE in combination with AlpE, followed by 18 weeks with RH alone, to assess efficacy, safety and pharmacokinetics of AlpE. The study is being conducted in six African countries under the European Union’s IMI2 UNITE4TB project, with the Institute of Infectious Diseases and Tropical Medicine, LMU University Hospital Munich as the trial sponsor. Through this Phase 2b TB drug combination trial, BioVersys and its partner GSK are progressing the development of this unique combination and taking the next step in terms of dose finding and potential positioning of AlpE in future TB drug regimens. This trial is expected to read-out by the end of 2027.

Preceding this Phase 2b trial, AlpE a second Phase 2a trial in which AlpE was assessed over 14 days in an open-label trial in combination with first line TB drugs. Top-line data is expected to be available Q2 2026. AlpE was generally well tolerated in this trial, supporting the progression into Phase 2b. BioVersys also plans to initiate a Phase 2 trial in meningeal TB in H1 2026.

Alpibectir (previously 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. AlpE’s development has been strongly supported by European Union and European Pharmaceutical Industry through Innovative Medicines Initiative (IMI2) Joint Undertaking, EDCTP and now UNITE4TB. The compound represents a novel concept to overcome resistance and potentiate the activity of an existing antibiotic, ethionamide (Eto) or prothionamide (Pto), for the treatment of TB, as demonstrated in a previous 7-day early bactericidal activity Phase 2a clinical trial, recently published in the New England Journal of Medicine,[3] which provided a first human proof-of-concept. 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 (FDA), and similarly in 2025, AlpE was granted Orphan Designation from the European Medicines Agency (EMA).

Dr. Glenn E. Dale, Chief Development Officer of BioVersys: “Alpibectir consistently shows promise as a new therapeutic option in combination with ethionamide for addressing tuberculosis. It’s considered to be generally well tolerated with a promising safety profile demonstrated across a number of Phase 1 and Phase 2 clinical trials, and has already demonstrated clinical proof of concept, with 7-day early bactericidal activity similar to isoniazid in patients with tuberculosis in a Phase 2a study. We are now excited to investigate AlpE in this longer clinical study, in combination with first-line TB drugs.”

Prof. Michael Hoelscher, Director, Institute of Infectious Diseases and Tropical Medicine and Principal Investigator of the STEP2C trial: “With the evaluation of alpibectir, UNITE4TB is testing its fifth novel drug candidate in its innovative Phase 2b regimen selection platform, where we evaluate how novel assets are best combined with other licensed or new drugs. This approach will help to derisk the chance of progressing the wrong combination into Phase 3. LMU Hospital is proud to be the sponsor of a trial for such a promising drug.“

David Barros-Aguirre Head of Global Health Medicines R&D, GSK and UNITE4TB Project Lead: “Tuberculosis (TB) remains a major public‑health threat, disproportionately affecting vulnerable communities in high‑burden countries. Advancing alpibectir‑ethionamide (AlpE) into a Phase 2b trial, in combination with first‑line TB drugs, represents an important step in addressing isoniazid resistance and evaluating the potential of this combination for the treatment of other forms of drug‑resistant TB. Through our longstanding partnership with BioVersys and UNITE4TB, we remain committed to changing the trajectory of the TB epidemic.”

Dr. Marc Gitzinger, Chief Executive Officer of BioVersys: “We are grateful to all our partners for their support of the clinical development of AlpE for TB patients. The unique clinical trial platform, UNITE4TB, provides the ideal opportunity to investigate AlpE’s potential benefit for TB patients. UNITE4TB is a landmark EU IHI program public and private partnership setting new standards in TB drug development and future regimen finding. We are excited to include AlpE in this program and investigate it alongside other novel assets with the potential to transform the future care for TB patients.”

About tuberculosis (TB)

Tuberculosis (TB) remains one of the leading causes of death worldwide. It is caused by the bacterial pathogen Mycobacterium tuberculosis (Mtb). According to the WHO Global Tuberculosis Report 2025, an estimated 10.7 million people developed TB in 2024, and approximately 1.23 million died from TB.

Drug resistance continues to pose a major challenge. There were about 390,000 people who developed rifampicin-resistant TB (RR-TB) or multidrug-resistant TB (MDR-TB) in 2024. MDR-TB remains a public health crisis and a health security threat, with global treatment success rates at only 71%.

The major burden of TB is concentrated within 30 high TB burden countries, accounting for 87% of the global total in 2024. Of those, the top eight countries for TB cases worldwide were, India (25%), Indonesia (10%), the Philippines (6.8%), China (6.5%), Pakistan (6.3%), Nigeria (4.8%), the Democratic Republic of the Congo (3.9%) and Bangladesh (3.6%). Globally, 8.3 million people were reported as newly diagnosed with TB in 2024, Significantly, it remains that 3.2% of new TB cases and 16% of previously treated cases are MDR/RR-TB.

About Alpibectir

Alpibectir (previously 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. Alpibectir acts through a novel mode of action, potentiating the activity of the anti-TB drug ethionamide (Eto). Alpibectir is being studied for its potential to, lower the efficacious human dose of Eto, minimizing of dose-dependent side effects, and overcome Eto resistance. The combination alpibectir/Eto (AlpE) is being developed for the treatment of pulmonary TB and TB meningitis. In 2023 AlpE was granted orphan-drug designation (ODD) for the treatment of tuberculosis, by the U.S. Food and Drug Administration (U.S. FDA) providing for certain incentives including seven years US market exclusivity. Similarly in 2025, AlpE was granted Orphan Designation from the European Medicines Agency (EMA), providing for certain incentives including 10-year EU market exclusivity.

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 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 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.

BioVersys contact

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

For Media: media@bioversys.com

www.bioversys.com

This communication reflects the author's view. Neither IHI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained therein.

Disclaimer

This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning BioVersys and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of BioVersys to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. BioVersys is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

[1] RZE in TB treatment refers to rifampicin (R), pyrazinamide (Z) and ethambutol (E), key first-line drugs in standard therapy for DS-TB.

[2] RH in TB treatment refers to rifampicin (R) and isoniazid (H), key first-line drugs in standard therapy for DS-TB.

[3]The Revival of Ethionamide by Alpibectir (BVL-GSK098), Michel Pieren et al, 2026; https://www.nejm.org/doi/full/10.1056/NEJMc2504287