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RNS Number : 6595T  Bio Versys AG  19 February 2026

 BioVersys AG / Key word(s): Scientific publication

BioVersys and partners' phase 2a tuberculosis trial results published in New
 England Journal of Medicine

19.02.2026 / 07:17 CET/CEST

 

Basel, Switzerland, February 19, 2026, 7am CET

·      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.

 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 profile of
 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: https://taskclinical.com/beto-tb/
 (https://taskclinical.com/beto-tb/)

 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 www.edctp.org
 (http://www.edctp.org) .

 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 https://taskclinical.com/ (https://taskclinical.com/)    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
 (mailto:hernan.levett@bioversys.com)

For media: media@bioversys.com (mailto:media@bioversys.com)
  Website: www.bioversys.com
 (https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.bioversys.com%2F&data=05%7C02%7Chernan.levett%40bioversys.com%7Cdfe061767cf041ea42a408dde46a1aca%7C5fb5ac400b8e4fe1b77876538e63042c%7C0%7C1%7C638917866560024484%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C60000%7C%7C%7C&sdata=21yQk8hjTb%2F1%2Ba2ufRO5trkK3urt6LPJPLgLnQRpGRc%3D&reserved=0)

 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
 al, 2026; https://www.nejm.org/doi/full/10.1056/NEJMc2504287
 (https://www.nejm.org/doi/full/10.1056/NEJMc2504287)

End of Media Release

·      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.

 

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 profile of
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: https://taskclinical.com/beto-tb/
(https://taskclinical.com/beto-tb/)

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 www.edctp.org
(http://www.edctp.org) .

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 https://taskclinical.com/ (https://taskclinical.com/)    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
(mailto:hernan.levett@bioversys.com)

For media: media@bioversys.com (mailto:media@bioversys.com)
 Website: www.bioversys.com
(https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.bioversys.com%2F&data=05%7C02%7Chernan.levett%40bioversys.com%7Cdfe061767cf041ea42a408dde46a1aca%7C5fb5ac400b8e4fe1b77876538e63042c%7C0%7C1%7C638917866560024484%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C60000%7C%7C%7C&sdata=21yQk8hjTb%2F1%2Ba2ufRO5trkK3urt6LPJPLgLnQRpGRc%3D&reserved=0)

 

 

 

 

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
al, 2026; https://www.nejm.org/doi/full/10.1056/NEJMc2504287
(https://www.nejm.org/doi/full/10.1056/NEJMc2504287)

 

 

End of Media Release

2278292  19.02.2026 CET/CEST

 

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