Latest news with #Acinetobacter
Fast Company
29-05-2025
- Business
- Fast Company
This new antibiotic may finally put a stop to some of the world's most drug-resistant pathogens
'Gram-negative bacteria' pose a huge threat to public health. With deathly adaptability, these types of bacteria are able to develop resistance to many antibiotics and survive in a wide range of conditions. In particular, Acinetobacter baumannii, also known as CRAB, is one of clinical medicine's most antibiotic resistant pathogens, killing hundreds in the U.S. every year with estimated mortality rates ranging from 26.0% to 55.7%. But a new antibiotic from Swiss pharmaceutical company Roche could change the future of how we treat Gram-negative bacteria. Roche announced on Monday that its antibiotic zosurabalpin will enter phase 3, late-stage human trials, by the end of this year or early next year. If successful, the drug will be the first new class of antibiotics targeting Gram-negative bacteria to be developed in over 50 years. What makes Gram-negative bacteria so hard to treat? Antibiotics treat illness by killing bacteria or suspending bacterial growth. But in order to access and attack crucial parts of the bacteria, most antibiotics must first pass through their outer membranes. However, Gram-negative bacteria are distinguished from other forms of bacteria because they are protected by a second outer membrane. These outer membranes are covered in protective molecules called lipopolysaccharides (LPS), which stabilize the membranes and create a barrier to most drugs and antibiotics. This resistance makes Gram-negative bacteria extremely tricky to treat, especially with patients who are already immunocompromised. It causes around a fifth of ICU infections, and most cases of ventilator-associated pneumonia, bloodstream infections related to catheters, and sepsis developed from the ICU. How does zosurabalpin help? Roche collaborated with Harvard researchers to develop a new way to stop Gram-negative bacteria. They found that the key was to inhibit the transportation of LPS molecules, the armor that creates the structure of the bacteria's outer membrane. Zosurabalpin is able to destroy Gram-negative bacteria by jamming LPS molecules inside the bacteria, weakening its membrane. It is the first of its class of antibiotics, and the first new class of antibiotics for Gram-negative bacteria since 1968. 'This antibiotic is important, but it can also serve as a catalysis point for future innovation,' said Michael Lobritz, global head of infectious diseases at Roche, to the Financial Times. 'There are very few [new classes of antibiotics] . . . that have been discovered in the last 15 years. So if you are able to launch a new one, we can build off that for decades to come.' Basel-based Roche has a vast portfolio that includes treatments for cancer, severe eye diseases, and multiple sclerosis. The company reported sales of roughly $68.7 billion in 2024, marking growth of 7% over the previous year on a constant exchange rate basis.
Telegraph
26-05-2025
- Health
- Telegraph
First new antibiotic in 50 years to tackle superbug
The first new antibiotic in 50 years to tackle a common superbug will be tested on patients. The drug, which targets one of the bacteria considered to pose the biggest threat to human health, has been hailed as an 'exciting' development in the fight against antibiotic resistance. On Monday, Roche, the Swiss pharmaceutical giant, announced that it will take zosurabalpin into the third and last phase of testing on humans. It is the first drug in five decades to show promise of tackling Acinetobacter baumannii, a pathogen which is described as a 'priority' by the World Health Organisation and an 'urgent threat' by the Centers for Disease Control and Prevention, the US national public health agency. The drug-resistant bacteria disproportionately impact patients who are in the hospital, causing infections such as pneumonia and sepsis. It is estimated that between 40 and 60 per cent of infected patients, many of whom are immunocompromised because of conditions such as cancer, die as a result of the bug. One of the reasons it is so difficult to treat is that it has a double-walled 'membrane' protecting it from attack, so it is difficult to get drugs into it and to keep them in, experts say. Zosurabalpin, which has been developed alongside researchers at Harvard University, targets the 'machine' which stops the outer membrane from forming properly. It works differently to all existing antibiotics and it is hoped that it could lay the foundations for future drugs. Drug-resistant bacteria Michael Lobritz, global head infectious diseases at Roche, said: 'Our goal is to contribute new innovations to overcome antimicrobial resistance, one of the biggest infectious disease challenges to public health.' The phase-three trial, which it is hoped will start later this year or in early 2026, will look at around 400 patients with a carbapenem-resistant Acinetobacter Baumannii (CRAB) infection who will either receive zosuarbalpin or the current standard of care. It is hoped that the drug will be approved by the end of the decade. Larry Tsai, senior vice president and global head of immunology and product development at Genentech, a unit of Roche, said that the drug-resistant bacteria 'are present in every country of the world' . He said that 'the innovative biology involved in this research could potentially reveal new insights into the structure of bacterial membranes, possibly leading to the discovery of new antibiotics in the future'. Pharmaceutical companies, including Roche, have in the past been unwilling to pursue new antibiotics because of a difficult market in which the drugs are used sparingly to try and avoid resistance. However, the UN has warned that if nothing is done to address the issue, drug-resistant diseases could cause 10 million deaths each year by 2050 and cause a worldwide financial crash. 'Exciting development' Dr Alistair Farley, scientific lead at the Ineos Oxford Institute, has welcomed zosurabalpin as an 'exciting development' for the field. 'There is an urgent unmet clinical need to develop new antibiotics against priority pathogens such as CRAB where antimicrobial resistance is a major concern,' he said. Dr Farley added that it 'may provide a route to the development of new drugs'. Studies showing that it worked 'extremely well' in test-tubes and mice were published in the journal Nature earlier this year. Prof Laura Piddock, scientific director of the Global Antibiotic Research and Development Partnership, said at the time that it provided 'definite hope' for other hard-to-treat infections. 'What is exciting about this discovery is that one of the building blocks that are part of the outer part of this bacterial cell is disrupted by this new drug,' Prof Piddock said. Antimicrobial resistance was declared by world leaders to be 'one of the most urgent global health threats' at the UN General Assembly earlier this year. The declaration committed members to establish independent panels on antimicrobial resistance, as many have done for climate change, and to reduce deaths linked to resistance by 10 per cent by 2030.
Yahoo
01-04-2025
- Business
- Yahoo
BioVersys secures patent claims in China for BV100
Biopharmaceutical company BioVersys has announced the grant of key patent claims in China for BV100, the intravenous formulation of rifabutin. The technology is being developed to combat resistant hospital infections caused by the Acinetobacter baumannii-calcoaceticus complex, including carbapenem-resistant strains (CRAB). BioVersys highlighted the urgent need for safe treatments for CRAB infections, which can have death rates in hospitals as high as 50%. According to recent epidemiology data, the company estimates that more than one million individuals in China suffer from severe CRAB-related pneumonia and bloodstream infections every year. BV100's mode of action enables rifabutin's 'active uptake' into the Gram-negative bacterial species Acinetobacter baumannii, targeting the ribonucleic acid (RNA)-polymerase enzyme. It is under development for treating ventilator-associated bacterial pneumonia (VABP), hospital-acquired bacterial pneumonia (HABP), and bloodstream infections (BSI). BioVersys CEO Dr Marc Gitzinger said: 'With the addition of China, we now have patents protecting BV100 granted in all the major markets, covering more than 25 countries. In our commitment to bring BV100 as a life-saving medicine to patients as fast as possible, this addition to our patent coverage is key due to the absolute number of patients affected by Acinetobacter infections in China. 'We are preparing to start a Phase I clinical trial in China soon, which will enable us to include China in our BV100 Phase III registration trial, which is planned to start in H2 2025.' In May 2019, the US Food and Drug Administration (FDA) granted the candidate qualified infectious disease product (QIDP) designation for VABP, BSI, and HABP, which paved the way for fast-track designation, priority review, and a five-year market exclusivity extension on approval of the initial QIDP indication. Last May, BioVersys and GSK announced the expansion of their strategic collaboration to expedite the clinical development of alpibectir (BVL-GSK098) for tuberculosis treatment. "BioVersys secures patent claims in China for BV100" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Associated Press
31-03-2025
- Business
- Associated Press
BioVersys Announces Important BV100 Patent Granted by Chinese Patent Office
BASEL, Switzerland, March 31, 2025 (GLOBE NEWSWIRE) -- Ad hoc announcement pursuant to Art. 53 LR Important patent around BioVersys' BV100 drug candidate has been granted, protecting the proprietary rifabutin IV formulation technology in China BV100 patents have now been granted in over 25 countries, including in US, Europe, UK and China 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 the company was granted important patent claims in China for its BV100 technology. BV100 is a novel formulation of rifabutin which is suitable for intravenous administration. BV100 is based on the newly identified mode of action for the active uptake of rifabutin into the Acinetobacter baumannii-calcoaceticus complex and is being developed for resistant hospital infections caused by Acinetobacter baumannii, including carbapenem resistant strains (CRAB). There is a serious lack of effective and safe treatment options for CRAB infections and mortality rates in hospitals can be as high as 50%. CRAB has been designated a priority pathogen by the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC). While CRAB infections are a serious health threat throughout the world, incidence rates for Acinetobacter infections are particularly high in China and Asia, combined with very high resistance rates of 60-80%. Based on recent epidemiology data, BioVersys expects > 1 million patients annually in China alone suffering from severe CRAB pneumonia and blood stream infections. Dr. Marc Gitzinger, Chief Executive Officer: 'With the addition of China, we now have patents protecting BV100 granted in all the major markets, covering more than 25 countries. In our commitment to bring BV100 as life-saving medicine to patients as fast as possible, this addition to our patent coverage is key due to the absolute numbers of patients affected by Acinetobacter infections in China. We are preparing to start a Phase 1 clinical trial in China soon, which will enable us to include China in our BV100 Phase 3 registration trial which is planned to start in H2 2025. Accessing the Chinese market will allow BV100 to target a global peak sales potential of USD 800 million and tackle unacceptably high carbapenem resistance rates and associated high mortality rates of up to 50%, from Acinetobacter baumannii hospital infections.' About BV100 BV100 is a novel formulation of rifabutin suitable for intravenous administration, with a recently discovered novel mode of action showing an active uptake of rifabutin into the Gram-negative bacterial species, Acinetobacter baumannii. For the first time, the lead candidate allows for the targeting of the RNA-polymerase enzyme in Gram-negative bacteria with a human-suitable dose. BV100 is being developed for the treatment of infections caused by Acinetobacter baumannii calcoaceticus complex (ABC), including Carbapenem-Resistant ABC (CRAB) in critically important indications of ventilator associated bacterial pneumonia (VABP), hospital-acquired bacterial pneumonia (HABP) and bloodstream infections (BSI). BV100 was granted QIDP Designation by the U.S. FDA in May 2019 for use in the treatment of VABP, HABP and BSI, making BV100 eligible for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity upon approval of the first QIDP indication. About Acinetobacter baumannii Acinetobacter baumannii calcoaceticus complex (ABC) are Gram-negative bacteria found in the environment (e.g., in soil and water) and an opportunistic pathogen in humans, typically infecting critically ill and immunocompromised patients, that can result in severe pneumonia and bloodstream infections in addition to affecting other parts of the body. ABC is considered a significant worldwide threat in the healthcare setting given its ability to survive for prolonged periods on surfaces, combined with its ability to develop or acquire resistance to standard of care antibiotics, e.g. carbapenems. Carbapenem-resistance as well as multidrug-resistance (MDR) rates for ABC are among the highest recorded for any bacteria in current times (The Lancet 2022; 399: 629–55). Incidence and resistance rates for ABC are trending upwards and COVID-19 has exacerbated this significantly. BioVersys forecasts the annual number of carbapenem-resistant A. baumannii infections in hospitals to have surpassed one million globally and due to the limited treatment options, such infections come with high (up to 50%) mortality rates. 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 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.
