Latest news with #MichaelLobritz
Arabian Post
12-06-2025
- Health
- Arabian Post
Breakthrough Antibiotic to Combat Deadly Superbug Advances
Swiss pharmaceutical firm Roche has advanced its antibiotic candidate, zosurabalpin, into Phase 3 clinical trials, representing a potential landmark in the fight against Gram-negative bacterial infections. Targeting carbapenem-resistant Acinetobacter baumannii, the drug could mark the first approval of a novel antibiotic class in more than 50 years. Zosurabalpin, a tethered macrocyclic peptide developed in collaboration with Harvard University, disrupts the outer lipopolysaccharide membrane essential for bacterial survival. Early-stage studies demonstrated favourable safety and pharmacokinetic profiles, while animal models of lung and thigh infections caused by CRAB confirmed its therapeutic potential. Roche anticipates enrolling approximately 400 hospitalised patients worldwide in the upcoming trial round, with the aim of comparing zosurabalpin directly against current standard-of-care antibiotics. The urgency of this development is underscored by CRAB's classification by the US Centers for Disease Control and Prevention as an 'urgent threat' and by the World Health Organization as a high priority pathogen. Infection fatality rates hover around 40–60%, particularly among immunocompromised patients such as those in intensive care. Existing antibiotics are often ineffective due to CRAB's robust outer membranes that thwart drug penetration. ADVERTISEMENT Phase 3 trials are scheduled to begin late this year or in early 2026, spanning over 100 global sites and aiming for regulatory submission by the decade's end. Roche executives emphasise that approval would not only address a dire clinical need but also serve as a catalyst for renewed antibiotic research, especially against Gram-negative organisms. 'Finding new classes is very hard,' noted Michael Lobritz, Roche's global head of infectious diseases; approval could lay groundwork for future innovation. Roche has previously stepped back from antibiotic R&D, but a reinvestment around ten years ago has now yielded zosurabalpin. The firm is simultaneously exploring additional novel compounds, including a LepB inhibitor targeting carbapenem-resistant Gram-negative pathogens in urinary tract infections. Efforts to restore antibiotic pipelines have gained traction from policymakers. The UK introduced a subscription-style payment model to support antimicrobial development, decoupling revenue from volume to ensure steady returns. The US is now considering similar incentives. Such frameworks aim to overcome financial disincentives that have plagued the industry, contributing to the closure of many smaller biotechs focusing on antibiotics. Meanwhile, complementary research is underway. A novel molecule named lariocidin was identified from soil bacteria by scientists at McMaster University. It targets the bacterial ribosome through a distinctive lasso-peptide structure but remains in preclinical stages. Similarly, researchers at MIT and McMaster have used artificial-intelligence methods to develop abaucin, a narrow-spectrum compound effective in killing CRAB. Both discoveries offer hope for expanding the antibiotic pipeline beyond zosurabalpin. Zosurabalpin's mechanism of action—from inhibiting lipopolysaccharide transport to compromising the bacterial envelope—distinguishes it from older therapies, which have often been broad-spectrum and prone to fostering resistance. By contrast, this new agent is narrow-spectrum, tailored to CRAB and avoiding pre-existing resistance mechanisms. The evolving antibiotic landscape now features roughly 20 candidates in clinical development for high-priority pathogens, though historical attrition rates remain troubling. Financial instability has led to the collapse of several promising antibiotic-focused firms, exemplified by Achaogen's bankruptcy in 2019 shortly after FDA approval of plazomicin. In light of these challenges, zosurabalpin represents a critical test case: its success could prove the viability of targeted, high-impact antibiotic development supported by improved economic incentives. As Roche and its collaborators gear up for the pivotal Phase 3 trial, global health advocates view the outcome not only as a potential therapeutic breakthrough, but as a signal of renewed momentum in a sector long plagued by stagnation.
India Today
27-05-2025
- Health
- India Today
Antibiotic for deadly superbug behind hospital infections enters final trials
A new drug that could help combat one of the world's most dangerous drug-resistant bacteria is now entering its final stage of human trials. This potential breakthrough could help in the global fight against antibiotic pharmaceutical giant Roche announced on Monday that its experimental antibiotic, zosurabalpin, developed in collaboration with Harvard University, is moving into phase 3 final phase will test the drug on around 400 patients worldwide, focusing on its ability to treat infections caused by Acinetobacter baumannii, a bacteria known to cause severe hospital-acquired infections like pneumonia and Acinetobacter baumannii is a short, rod-shaped, gram-negative bacterium. Scientists call it an "opportunistic bacterial pathogen" as it affects people with weak immune systems, highly present in hospital baumannii has been recognised as an "urgent threat" by the US Centers for Disease Control and Prevention (CDC), and has become increasingly resistant to existing no new antibiotics targeting this superbug have been developed in over five decades. Swiss pharmaceutical giant Roche announced on Monday that its experimental antibiotic, zosurabalpin, developed in collaboration with Harvard University, is moving into phase 3 trials. () What sets zosurabalpin apart is that it works in a new way, using a mechanism that bacteria haven't yet found a way to resist. This fresh approach brings new optimism to a field where many treatments are failing due to antibiotic caused by drug-resistant bacteria are not only difficult to treat but also widespread. Globally, sepsis is estimated to cause 11 million deaths a year, while community-acquired pneumonia (CAP) kills 3 to 4 million people annually, especially among the elderly."Antimicrobial resistance is one of the biggest infectious disease challenges to public health. Our goal is to contribute new innovations to overcome this growing threat.',' said Michael Lobritz, Roche's global head of infectious diseases, told The Tsai, head of immunology and product development at Roche's US unit Genentech, added that Acinetobacter baumannii is present in every country. He added that the unique biology involved in developing zosurabalpin might even lead to future discoveries in the fight against other resistant phase 3 trial will compare the effects of zosurabalpin to current standard treatments, and if successful, the drug could be ready for approval by the end of this decade.
The Independent
27-05-2025
- Business
- The Independent
New ‘superbug' antibiotic to treat sepsis and pneumonia enters last phase of testing
A new antibiotic that has the potential to save millions of lives has entered its last phase of human testing. Swiss drugmaker Roche announced it would advance the testing of an antibiotic against a common bacterium that causes serious hospital infections like pneumonia and sepsis into the third and final stage of testing. The antibiotic zosurabalpin, which is jointly developed with Harvard University, is to be tested against drug-resistant acinetobacter baumannii bacteria. The Centres for Disease Control and Prevention (CDC) labels acinetobacter baumannii as an 'urgent threat', but there have been no antibiotics created which react to it in more than 50 years. Roche announced the phase 3 trial will be a single pivotal study with approximately 400 patients from around the world, randomised to receive either zosuarbalpin or the standard treatment. Michael Lobritz, global head of 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.' Larry Tsai, senior vice president and global head of immunology and product development at Genentech, a unit of Roche, said the drug-resistant bacteria 'are present in every country of the world'. He added 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'. It is hoped the experimental drug will be approved by the end of the decade. Globally, sepsis is estimated to cause approximately 11 million deaths each year – one death every 2.8 seconds. Worldwide, community-acquired pneumonia (CAP) kills three to four million people each year with high morbidity and mortality, particularly among elderly patients.
Irish Independent
27-05-2025
- Health
- Irish Independent
First new antibiotic in 50 years could help treat superbug labelled ‘urgent threat'
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. Yesterday, Roche, the Swiss pharmaceutical giant, announced 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 Centres 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 40pc and 60pc 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 said. 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. 'Our goal is to contribute new innovations to overcome antimicrobial resistance, one of the biggest infectious disease challenges to public health,' Michael Lobritz, global head infectious diseases at Roche, said. 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 zosurabalpin or the current standard of care. It is hoped that the drug will be approved by the end of the decade. Pharmaceutical companies 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.
Yahoo
26-05-2025
- Health
- Yahoo
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. 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. 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. Broaden your horizons with award-winning British journalism. Try The Telegraph free for 1 month with unlimited access to our award-winning website, exclusive app, money-saving offers and more.
