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October 22, 2024

BioVersys Joins Eu-Funded RespiriNTM Programme to Accelerate Development of its Broad-Spectrum Drug Candidates Against NTM Pulmonary Diseases

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Basel, Switzerland. October 22, 2024, 7am CEST

  • RespiriNTM Programme allows BioVersys’ NTM project to access up to €2 million of non-dilutive funding
  • BioVersys taps into key expertise of the established RespiriNTM consortium members and will lead development of its candidates through preclinical and clinical studies
  • BioVersys’ NTM candidates are derived from the company’s proprietary Ansamycin Chemistry platform and are being developed to address difficult-to-treat Mycobacterium avium complex (MAC) and Mycobacterium abscessus subspecies (MAB) infections

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 that it has joined the EU-funded RespiriNTM programme, an 8-year journey exploring multiple approaches to determine new targets for anti-mycobacterial compounds, define and optimize novel inhibitors and move these through the process of hit-to-lead up until the First-in-Human trials. BioVersys’ in-house non-tubercular mycobacteria (NTM) project will have access to up to approximately €2 million in non-dilutive funding from the original IMI2 RespiriNTM grant of approximately €5.7 million, and to key capabilities of established consortium partners to develop novel candidates to address NTM pulmonary disease (NTM-PD).

NTM-PD is estimated to affect more than 86,000 people in the US according to the American Lung Association and antimicrobial resistance (AMR) is a major global health threat with currently available therapeutics becoming more and more obsolete due to AMR.[1] This is of greatest concern when addressing NTM-PD, as chronic antibiotic treatments of 12-24 months required for these infections often lead to the development of antibiotic resistance. Due to the lack of effective treatment options, current cure rates for NTM-PD are as low as 30-50%.[2] Particularly vulnerable to NTM-PD are people who suffer from structural airway diseases such as cystic fibrosis, COPD and bronchiectasis.

BioVersys’ NTM program is derived from the company’s proprietary Ansamycin Chemistry platform. The BioVersys’ research team is developing a novel and highly potent broad-spectrum anti-NTM ansamycin, suitable for oral or inhalation therapy that is devoid of cross-resistance with other therapeutic classes. Since NTM-PD patients are often on multi-drug regimens, the company focuses on developing molecules that do not show any significant potential for drug-drug interactions.

Meindert H. Lamers, Associate Professor, Leiden University Medical Center & RespiriNTM Project Coordinator: “Working together with BioVersys on the RespiriNTM project is a unique opportunity. Their powerful ansamycin class of inhibitors have the potential to provide an effective and highly needed treatment option for NTM infections, which fits perfectly with the aims of the RespiriNTM project. BioVersys’ strong drive to deliver a novel NTM antibiotic has invigorated the RespiriNTM project. Our collaboration to date has been very stimulating and I am very much looking forward to deepening our collaboration with BioVersys over the coming years.”

Dr. Sergio Lociuro, Chief Scientific Officer of BioVersys: “Following on from the recent successes of TRIC-TB, we are very pleased to have the opportunity to join a second IMI2 JU funded programme, which is tackling another area of high unmet medical need. RespiriNTM is a strong consortium of many expert partners with valuable experience in the field of antimicrobial resistance. We aim to develop our broad-spectrum NTM candidates into effective treatments against these difficult to treat pulmonary diseases to positively impact patients’ lives.”

About RespiriNTM

Mycobacterium avium complex (MAC) and Mycobacterium abscessus subspecies (MAB) cause several hundreds of thousands of infections worldwide each year. Unlike the well know related species M. tuberculosis, there are currently limited and poor treatment options to address these pathogens with significant levels of relapse and unacceptably high mortality rates, approaching 45%.[3] Therefore, there is an urgent need for antibiotics that can treat the debilitating diseases that are caused by the Non-Tuberculous Mycobacteria (NTM), M. avium complex and M. abscessus. The RespiriNTM project aims to develop novel antibiotics that target the RNA transcription machinery that is required for protein production in the cell. Through this work we aim to develop desperately needed antibiotics that work against M. avium and M. abscessus that form an increasing threat to global health. RespiriNTM is part of the IMI AMR Accelerator Programme.

About non-tubercular mycobacteria

Non-tuberculous Mycobacteria (NTM) are ubiquitous environmental bacteria whose common clinical manifestation is pulmonary disease (NTM-PD) caused most frequently by Mycobacterium avium complex (MAC) and Mycobacterium abscessus subspecies (MAB).[4] NTM-PD affects approximately 250,000 people per year, predominantly in North America and Asia.4 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[5] are considered only moderately effective for treating MAC, whereas no therapy of predictable efficacy exists for the treatment of M. abscessus, a pathogen associated with up to 50% mortality.[6] People with predisposed conditions, including cystic fibrosis (CF), other lung diseases and immune-compromised patients are more easily colonised. Alarmingly, the incidence of NTM infections among people living with CF has increased from 3.3% to 22.6%, with MAB becoming a very prominent pathogen.[7]

Statements or views expressed in this release are of those of the respective organizations or persons and the IMI2 JU is not responsible for any use of the information contained herein.

The RespiriNTM project has received funding from the Innovative Health Initiative 2 Joint Undertaking (JU) under grant agreement No 853932. This Joined Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.

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.

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 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, Tel. +41 61 633 22 50; Mail: IR@bioversys.com

www.bioversys.com
https://www.linkedin.com/company/bioversys-ag
https://www.twitter.com/bioversys

[1] Lancet, Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis, VOLUME 399, ISSUE 10325, P629-655, FEBRUARY 12, 2022

[2] Wang et al., 2022; Novosad et al., 2017; Lee et al., 2021; Mourad et al., 2021

[3] The Impact of Nontuberculous Mycobacteria Species on Mortality in Patients with Nontuberculous Mycobacterial Lung Disease. Wang et al, 2022, Frontiers in Microbiology. doi:10.3389/fmicb.2022.909274

[4] 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

[5] 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

[6] 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

[7] 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

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