GSK GSK plc

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, announced today the expansion of its strategic collaboration with the global biopharma company GSK plc (LSE/NYSE: GSK) to accelerate the clinical development of alpibectir (BVL-GSK098) for the treatment of tuberculosis (TB).

Alpibectir, a small molecule acting through a novel mode of action, was developed in a successful public-private collaboration with GSK, Pasteur Institute Lille and the University of Lille and is currently being evaluated in combination with ethionamide (Eto) in a Phase 2a proof-of-concept study in pulmonary TB patients in South Africa. The compound represents a totally new concept of overcoming resistance and significantly potentiating the activity of an existing antibiotic, ethionamide (Eto).

GSK and BioVersys will continue their collaboration beyond the current Phase 2a and develop alpibectir in both TB pulmonary and TB meningitis programs in order to make alpibectir available to patients as soon as possible.

As part of the expanded collaboration, GSK will take an equity stake in BioVersys' latest investment round. Adding to further investments from existing and new investors, this extends the Series C financing by CHF 12.3 million, resulting in total proceeds of CHF 44.9 million for the Series C round to date. The additional proceeds will enable the further clinical development of BioVersys’ portfolio which also includes BV100, a potential breakthrough hospital antibiotic with a new mode of action targeting Acinetobacter baumannii, the most drug-resistant bacterial pathogen.  

Dr. Marc Gitzinger, Chief Executive Officer and founder of BioVersys: "We are very pleased to announce both the expansion of our highly successful strategic collaboration with GSK and our partner’s participation in our latest financing round. Together with GSK, we successfully advanced the development of alpibectir for TB, having recently completed the TRIC-TB public-private partnership program with the delivery of a Phase 2-ready anti-TB molecule. We look forward to further expanding this collaboration with GSK beyond our ongoing Phase 2a evaluation of alpibectir, as we seek to deliver a new treatment regimen for TB, a disease that poses a serious threat to public health worldwide and which is severely underserved by current therapies."

Thomas Breuer, Chief Global Health Officer, GSK: "GSK is committed to changing the trajectory of tuberculosis and we’re excited to expand our partnership with BioVersys in the continued development of alpibectir, a drug candidate with the potential to broaden the treatment options for TB. We believe that working in partnership on priorities that are aligned to and support global health challenges gives both companies the opportunity to achieve maximum health impact at scale.”

About tuberculosis (TB) Tuberculosis (TB) is one of the leading causes of death worldwide. Its causative agent is the bacterial pathogen Mycobacterium tuberculosis (Mtb). Worldwide, an estimated 10.6 million people developed TB in 2022 and an estimated 1.30 million died from TB. WHO estimates that there were 410’000 new cases with resistance to rifampicin – the most effective first-line drug – most of them were multi-drug resistant (MDR). MDR-TB remains a public health crisis and a health security threat. Worldwide, only 63% 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 was in eight countries: India (27%), Indonesia (10%), China (7.1%), the Philippines (7.0%), Pakistan (5.7%), Nigeria (4.5%), Bangladesh (3.6%) and the Democratic Republic of the Congo (3.0%). Furthermore, 3.3% of all new and 17% of reoccurring TB cases were MDR/RR-TB.  

About GSKGSK is a science-led global healthcare company. For further information please visit https://www.gsk.com/en-gb/about-us/

About BioVersysBioVersys 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.comX: www.twitter.com/BioversysLinkedin: www.linkedin.com/company/bioversys-ag

_________________________________________1 Global Tuberculosis Report 2023 WHO