Bioversys AG: Bioversys Successfully Advances BV500 NTM Program With Continued Support From CF AMR Syndicate

BioVersys AG / Key word(s): Miscellaneous
BIOVERSYS SUCCESSFULLY ADVANCES BV500 NTM PROGRAM WITH CONTINUED SUPPORT FROM CF AMR SYNDICATE

11.02.2025 / 07:00 CET/CEST

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Basel, Switzerland. February 11, 2025, 7am CET

• BV500 reaches second milestone, with the advancement of multiple broadly profiled and highly potent oral Lead candidates with demonstrated broad-spectrum in vitro and in vivo efficacy against non-tuberculous mycobacteria (NTM).
• Continued strategic support from LifeArc through the CF AMR Syndicate Collaborative Discovery Programme (CDP), accelerating the development of novel therapies for difficult-to-treat NTM lung disease in cystic fibrosis (CF) patients.
• Leveraging its proprietary Ansamycin Chemistry platform, BioVersys' BV500 molecules are designed to overcome resistance and address highly drug-resistant NTM infections.

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 its BV500 NTM program has reached its second milestone, "identification of up to 5 Optimized Lead compounds", under the CF AMR Syndicate Collaborative Discovery Programme (CDP) agreement. Supported by LifeArc funding, BioVersys is developing novel small molecules targeting difficult to treat non-tuberculous mycobacteria lung disease (NTM-LD) in people with cystic fibrosis (CF).

The company's BV500 NTM program is derived from its proprietary Ansamycin Chemistry platform from which the research team has identified and is developing several advanced, highly potent ansamycin oral Lead candidates, with broad-spectrum in vitro and in vivo anti-NTM activity, and which are devoid of cross-resistance with other therapeutic classes.

Dr. Nawaz Khan, Head of Research at BioVersys: "We are very pleased with the progress of our BV500 program, the fourth of a series of successful pipeline programs, targeting high unmet medical need in antimicrobial resistance (AMR). Together with our collaboration partners from the CF AMR Syndicate (LifeArc, Medicines Discovery Catapult and Cystic Fibrosis Trust), we continue to show how successful partnerships can be developed to address patients suffering with difficult to treat NTM-LD, through synergizing a broad range of complementary expertise."

Dr. Catherine Kettleborough, Head of Chronic Respiratory Infection Translational Challenge at LifeArc: "Addressing the urgent challenge of NTM lung disease in people with cystic fibrosis requires innovation and collaboration. The progress of the BV500 program demonstrates the impact of bringing together scientific expertise to accelerate the development of much-needed treatments. We are proud to support BioVersys in advancing this promising research, with the shared goal of improving outcomes for patients."

About non-tuberculous mycobacteria
Non-tuberculous Mycobacteria (NTM) are ubiquitous environmental bacteria whose common clinical manifestation is pulmonary (lung) disease (NTM-PD or NTM-LD) caused most frequently by Mycobacterium avium complex (MAC) and Mycobacterium abscessus subspecies (MAB).^[1] NTM-PD affects approximately 250,000 people per year, predominantly in North America and Asia.³ Treatment of NTM infections is challenging due to variable intrinsic bacterial susceptibility, acquired resistance to commonly used antimicrobial agents, length of therapy (at least 12 months) and adverse effects associated with current treatment options. Macrolide-based, triple drug regimens, plus aminoglycosides for chronic/relapsing infections^[2] are considered only moderately effective for treating MAC, whereas no therapy of predictable efficacy exists for the treatment of MAB, a pathogen associated with up to 50% mortality.^[3] People with preexisting conditions, including cystic fibrosis (CF), other lung diseases and immune-compromised patients are more easily colonised. The incidence of NTM infections among people living with CF has increased from 3.3% to 22.6%, with MAB becoming a more prominent pathogen.^[4]

About the CF AMR Syndicate
The CF AMR Syndicate is a cross-sector initiative that brings together leading experts in CF and AMR from industry, academia and the clinic with people with CF. The Syndicate's aim is to accelerate the translation of CF antimicrobials and diagnostics to the clinic and bring new and effective treatment options to people with CF. The Syndicate was established in 2019 and is jointly managed by Medicines Discovery Catapult, Cystic Fibrosis Trust and LifeArc.www.cfamr.org.uk

About LifeArc
LifeArc is a self-funded, non-profit medical research organisation. We take scientific ideas out of the lab and help to turn them into medical breakthroughs that can be life-changing for patients. We have been doing this for more than 25 years and our work has resulted in five licensed medicines and a diagnostic for antibiotic resistance. Our teams are experts in drug and diagnostics discovery, technology transfer, and intellectual property. Our work is in translational science - bridging the gap between academic research and clinical development, providing funding, research and expert knowledge, all with a clear and unwavering commitment to having a positive impact on patient lives.

LifeArc is a charity registered in England and Wales under 1015243 and in Scotland under SC037861.

About Medicines Discovery Catapult
Medicines Discovery Catapult (MDC) is a national Life Sciences service dedicated to turning drug discovery into commercial breakthroughs. At the frontier of drug discovery, MDC works with entrepreneurial scientists to make every move count. It validates their ideas, de-risks investments, and feeds insights back into the sector to drive productivity and impact.

MDC creates momentum through its unique blend of discovery expertise, technology, insights, and sector-leading partnerships. Where there is unmet patient need, MDC stimulates innovation through its National Programmes. MDC has helped over 300 companies raise more than £1.2bn of R&D investment. Its approach to drug discovery drives game-changing breakthroughs and improves patients' lives.

More information:

• Part of the Innovate UK Catapult Network
• Based in Alderley Park, Cheshire
• For more information, visit https://md.catapult.org.uk/

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^[1] Hamed KA & G. Tillotson "A narrative review of nontuberculous mycobacterial pulmonary disease: microbiology, epidemiology, diagnosis, and management challenges" Ex. Rev. Resp. Med. (2023), 17 (11), 973 - 988 https://doi.org/10.1080/17476348.2023.2283135

^[2] Daley CL et al. "Treatment of nontuberculous mycobacterial pulmonary disease: an official ATS/ERS/ESCMID/IDSA clinical practice guideline" Eur. Resp. J. (2020), 56, 2000535; https://doi.org/10.1183/13993003.00535-2020; Griffith DE et al. "An Official ATS/IDSA Statement: Diagnosis, Treatment, and Prevention of Nontuberculous Mycobacterial Diseases" Am. J. Respir. Crit. Care Med. (2007), 175, 367-416; https://doi.org/10.1164/rccm.200604-571ST

^[3] Jhun BW et al. "Prognostic factors associated with long-term mortality in 1445 patients with nontuberculous mycobacterial pulmonary disease: a 15-year follow-up study" Eur. Resp. J. (2020), 55, 1900798; https://doi.org/10.1183/13993003.00798-2019

^[4] Degiacomi G. et al. "Mycobacterium abscessus, an Emerging and Worrisome Pathogen among Cystic Fibrosis Patients" Int. J. Mol. Sci. (2019), 20, 5868; doi: 10.3390/ijms20235868

About the Cystic Fibrosis Trust
Cystic Fibrosis Trust is the only UK-wide charity dedicated to uniting for a life unlimited for everyone affected by cystic fibrosis. The Trust funds cutting edge research, provides confidential advice, support, and information on any aspect of cystic fibrosis, including help with financial support.

Since 2013, Cystic Fibrosis Trust has spent £12m on research to tackle CF lung infections, including world class research in our CF Innovation Hubs, our international, multidisciplinary Strategic Research Centres and our Venture and Innovation leverage funding awards.

The work the Trust does is only made possible by the generous donations from supporters. Visit our website to find out more about cystic fibrosis, the work of the Trust and how you can help.www.cysticfibrosis.org.uk

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. [phone]; [e-mail]
For Media: [e-mail]
www.bioversys.com

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End of Media Release

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2083985 11.02.2025 CET/CEST