Bedaquiline Fumarate

Data from Phase 2a study demonstrated the first clinical proof of concept for alpibectir in combination with ethionamide (AlpE) in the treatment of patients with tuberculosis. The results, published in the prestigious New England Journal of Medicine, underscore the significant potential of AlpE to shape the future of TB treatment. BASEL, Switzerland, Feb. 19, 2026 (GLOBE NEWSWIRE) -- 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 the publication of promising clinical proof of concept results in the prestigious New England Journal of Medicine from the Phase 2a clinical trial of AlpE in patients with pulmonary TB. 1 Tuberculosis is one of the leading causes of death by infectious diseases 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 potentiating the activity of an existing antibiotic, ethionamide (Eto), and was identified in a successful public-private collaboration with GSK, the Pasteur Institute of Lille and the University of Lille. The Phase 2a bEto-TB clinical trial was conducted in South Africa through a consortium of three partners, TASK, GSK and BioVersys, and was completed in April 2024. AlpE delivered a promising clinical proof of concept in a 7-day early bactericidal activity (EBA) study, conducted in patients with pulmonary tuberculosis. AlpE seeks to offer a replacement for isoniazid (INH) in the current first-line regimen or to be added as a novel bactericidal drug to future regimens including those of TB meningitis. The clinical development of AlpE has been strongly supported by several European Union grants and public private partnerships, including the EU Innovative Medicines Initiative 2 (IMI2), TRIC-TB project and UNITE4TB project, and the European & Developing Countries Clinical Trials Partnership (EDCTP2 programme), bEto-TB project. Dr. Glenn Dale, Chief Development Officer of BioVersys: “We are very pleased to see the favorable safety, tolerability and pharmacokinetics pro AlpE, and even more so for the promising signals of efficacy delivered from this Phase 2a clinical trial. These data give us real encouragement for the further Phase 2 studies in UNITE4TB, run by our partner GSK, where AlpE is being studied in combination with first line TB drugs. We are also excited as we plan to initiate a Phase 2 trial in meningeal TB later this year.” Michelle Nderu, Project Officer, EDCTP Association: “The bEto-TB trial demonstrates the power of sustained investment in global health research. The development of AlpE reflects not only scientific innovation but also the strength of collaborative partnerships. With support from EDCTP2, these results bring us a step closer to delivering shorter, safer and more effective treatment options for people living with TB.” Prof. Andreas Diacon, Founder and Chief Scientist at TASK: “At TASK we are grateful to our study participants whose collaboration allows yet another novel antibiotic to move a step forward. This study has shown that ethionamide, an established, low-cost and safe antibiotic, becomes more potent and better tolerated by the addition of alpibectir. The AlpE combination is now on its way to become part of drug combinations that treat tuberculosis patients with and without resistance to other drugs, and it appears particularly suitable for patients with tuberculosis meningitis where better treatments are direly needed.” Dr. David Barros-Aguirre, Head of Global Health Medicines R&D, GSK: “TB remains one of the world’s deadliest infectious diseases, and tackling drug resistance is one of the biggest challenges we face. That’s why innovation is essential. The Phase 2a results for AlpE mark an exciting step forward, demonstrating the potential of novel approaches to strengthen existing therapies. We are proud to collaborate with BioVersys, TASK and partners, to advance research aimed at transforming TB care for patients globally, particularly in lower-income countries where the disease remains most prevalent.” About bEto-TB 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 programme has previously received funding from the EU IMI 2 JU (TRIC-TB) and the Wellcome Trust. Project description website: X: Statements or views expressed in this release are those of the respective organizations or persons and the European & Developing Countries Clinical Trials Partnership is not responsible for any use of the information contained herein. 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 EDCTP The vision of the European & Developing Countries Clinical Trials Partnership (EDCTP) is to reduce 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, and diagnostics) to identify, prevent or treat infectious diseases, including emerging and re-emerging diseases. EDCTP’s approach integrates research with the development of African clinical research capacity and networking. EDCTP2 is supported by the European Union under Horizon 2020, its Framework Programme for Research and Innovation. For more information, visit . About TASK TASK is a social enterprise committed to developing, testing, and progressing novel medicines, vaccines, and diagnostics in various medical therapeutic areas, most notably in anti-tuberculosis drugs, aimed at improving global health care. Since its inception in 2005, TASK has grown exponentially and diversified into six distinct independent clinical research sites; a mycobacteriology bio-safety level 3 laboratory; a phase I to II clinical trial hospital with twenty-four beds; two registered dispensing pharmacies; a data management centre; regulatory, quality control and compliance office and a clinical research training academy. Over the last 15 years TASK has completed multiple research projects, many of global significance, 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 and follow us on Twitter @taskapplied. 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), and tuberculosis (alpibectir, Phase 2, 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 Website: X: LinkedIn: The bEto-TB project (grant reference: RIA2019AMR-2657) is part of the EDCTP2 programme supported by the European Union. 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 The Revival of Ethionamide by Alpibectir (BVL-GSK098), Michel Pieren et a l , 2026;

A new antibiotic for tuberculosis outperformed other treatment options without compromising safety in drug-sensitive patients, according to trial results released Wednesday. TB Alliance reported that the experimental drug sorfequiline, when combined with two other antibiotics, displayed greater ability to kill tuberculosis bacteria than bedaquiline, another antibiotic used to treat the infectious disease. The sorfequiline combo also showed better potency than the standard of care, a four-drug antibiotic regimen. Sorfequiline is an oral pill developed by TB Alliance, a government- and nonprofit-backed organization that has been working on developing new antibiotics to fight tuberculosis since 2000. The objective of the trial was to see whether sorfequiline could be added to the arsenal of treatments against tuberculosis, to combat anti-microbial resistance and further shorten treatment time. The standard treatment involves a four-drug mix for eight weeks, followed by two of those drugs, isoniazid and rifampicin, for at least another four months. “Now, we have an opportunity to shorten treatment even further — representing an important milestone toward our goal of developing an ultra-short regimen capable of treating both drug-sensitive and drug-resistant TB,” TB Alliance chief Mel Spigelman said in a statement. Tuberculosis is an infectious disease spread through the air. Millions of people live with inactive infection, which is asymptomatic, but it can manifest into an active case at any time if untreated. The CDC says that about one in 10 cases of inactive tuberculosis becomes active, and the Phase 2 study was in patients who had an active case. Last year, more than 1.2 million people died of the disease, according to the World Health Organization. The Phase 2 trial included 22 sites across South Africa, Georgia, the Philippines, Uganda and the United Republic of Tanzania. The alliance reported that sorfequiline had a comparable safety profile to the standard of care. Phase 3 plans are underway, and that trial is set to begin next year. TB Alliance says it is also developing a long-acting injectable option that could possibly drop the treatment time to as little as one month. The alliance also developed pretomanid, which was first approved by the FDA in 2019 to treat highly drug-resistant strains of tuberculosis as part of a regimen with bedaquiline. Pretomanid is also part of the regimen studied with sorfequiline.