Peptilogics project aims to prevent breakthrough blood stream infections caused by open fracture-related injuries
(BOSTON: January 9, 2025) – Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) will award Peptilogics US$3.3 million to develop and execute a workplan for its slow-release formulation of a novel, broad-spectrum therapeutic, zaloganan-CR, an engineered peptide intended for use in preventing infection after high-energy-traumatic bone injuries.
Zaloganan-CR, a controlled-release formulation of zaloganan, represents a unique approach to prevent fracture-related infections (FRIs) due to its rapid broad-spectrum antibacterial activity and an ability to present supra-inhibitory concentrations directly at the site of contamination.
Despite progress in infection control and systemic antimicrobial therapies, up to 40% of severe traumatic fracture-related injuries become infected. These FRIs can be biofilm-based, particularly on hardware and bone, increasing the resistance to standard antibiotic treatment and making progression to blood stream infection (BSI) more likely. BSIs linked to contaminated fractures with soft tissue injury remain a significant contributor to patient morbidity and mortality and lead to significantly increased healthcare costs.
This is the second award Peptilogics has received from CARB-X. Beginning in 2020, CARB-X supported the project through preclinical testing and demonstration of safety in a first-in-human study in patients with prosthetic joint infections. The new award aims at extending the therapeutic use of zaloganan with an optimized formulation in a new and underserved indication, broadening the utility of the product.
Every year, nearly one billion people sustain traumatic injuries, many of which result in wounds with high susceptibility for contamination and infection, such as open fractures, lacerations, and burns. Successful treatment is particularly challenging in low- and middle-income countries, such as India, where there are 14.1 million acute wounds and 4.5 million open fractures treated annually.
“Peptilogics’ development of zaloganan-CR offers the potential for a promising solution to combat fracture-related infections, which are a leading factor in patient complications and rising healthcare expenses,” said Erin Duffy, PhD, R&D Chief of CARB-X. “With its broad-spectrum activity and targeted delivery, zaloganan-CR has the potential to transform infection prevention in high-trauma injuries. We look forward to the continued progress in this critical area of healthcare.”
“We are delighted to extend and deepen our partnership with CARB-X to develop a controlled-release formulation for zaloganan. This additional funding allows us to accelerate our prevention program by addressing bloodstream infection linked to FRI, which is still a staggeringly large problem in surgical patient care,” said Jonathan Steckbeck, PhD, CEO of Peptilogics. “By tackling this problem, we will not only be advancing the science of infection prevention but also pave the way to deliver a new generation of breakthrough products to patients in need. Zaloganan-CR has the potential to dramatically reduce the long-term clinical and economic impact of these serious infections, ultimately transforming outcomes for patients worldwide.”
About zaloganan
Zaloganan is an investigational therapeutic with a unique mechanism of action that targets and disrupts bacterial membranes, causing rapid broad-spectrum bacterial inactivation. Zaloganan has an extensive data package demonstrating rapid, broad-spectrum bactericidal activity against a range of pathogens, including those classified by the World Health Organization and the Centers for Disease Control and Prevention as critical, urgent, or high-priority due to their role in causing severe bloodstream infections.
Zaloganan has demonstrated a systemic safety profile in a Phase 1a study in healthy human volunteers and in a Phase 1b clinical trial in patients with periprosthetic joint infection (PJI), a biofilm-mediated hardware infection. The unique attributes of zaloganan-CR delivered directly at the site of infection provide the potential for a significant change in the current standard of care by preventing a devastating clinical outcome.
CARB-X 2024 Funding Round
In March 2024, CARB-X launched a new funding solicitation to fill major R&D gaps in the global antibiotic development pipeline. More than 300 Expressions of Interest were accepted in four distinct product themes: therapeutics for infections caused by Gram-negative pathogens, prevention of invasive disease, diagnostics for neonatal sepsis, and proof-of-concept for novel sample types for diagnosing lower-respiratory tract infections. Additional projects are under review, and new awards will be announced later this year. Register for the CARB-X newsletter to learn about upcoming funding calls that will be announced in 2025.
When CARB-X was founded in 2016, the early-stage antibiotic pipeline was stalled. Since its inception, CARB-X has supported 106 R&D projects in 13 countries, and CARB-X product developers have made significant progress: 18 projects have advanced into or completed clinical trials; 12 remain active in clinical development, including late-stage clinical trials; and two diagnostic products have reached the market. Additionally, at least 9 product developers with active R&D projects have already secured advanced development partnerships to support their clinical development after leaving the CARB-X portfolio. All CARB-X-funded product developers are contractually obligated to develop a Stewardship and Access Plan for their product, outlining strategies to ensure responsible stewardship and appropriate access in low- and middle-income countries.
CARB-X is funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under agreement number 75A50122C00028 and by awards from Wellcome (WT224842), Germany’s Federal Ministry of Education and Research (BMBF), the UK Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Public Health Agency of Canada (PHAC), the Bill & Melinda Gates Foundation, and the Novo Nordisk Foundation. The U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in HHS, provides support in the form of in-kind services through access to a suite of preclinical services for product development. The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of any CARB-X funders.
CARB-X Contact: Marissa Novel, carbxpr@bu.edu
Peptilogics Contact: Nicholas Pachuda, nicholas.pachuda@peptilogics.com
About CARB-X
CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) is a global non-profit partnership dedicated to supporting early-stage antibacterial research and development to address the rising threat of drug-resistant bacteria. CARB-X supports innovative therapeutics, preventatives and rapid diagnostics. CARB-X is led by Boston University and funded by a consortium of governments and foundations. CARB-X funds only projects that target drug-resistant bacteria highlighted on the CDC’s Antibiotic Resistant Threats list, or the Priority Bacterial Pathogens list published by the WHO, with a priority on those pathogens deemed Serious or Urgent on the CDC list or Critical or High on the WHO list. https://carb-x.org/ | X (formerly Twitter) @CARB_X
About Peptilogics
Peptilogics develops medical solutions to improve the outcome of surgical problems. The company is building a pipeline-in-a-product platform around the lead asset, zaloganan. Zaloganan-Irrigation has successfully completed a Phase 1b clinical trial for periprosthetic joint infection treatment and is proceeding to a larger clinical trial in early 2025. Zaloganan-CR (controlled release) is being developed for the prevention of deep, invasive infections that lead to bloodstream infection (BSI). Peptilogics is supported by investments from Peter Thiel, Presight Capital, Founders Fund, CARB-X, and the Cystic Fibrosis Foundation.
About BARDA and NIAID
The U.S. Department of Health and Human Services works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The Administration for Strategic Preparedness and Response (ASPR) leads the nation’s medical and public health preparedness for, response to and recovery from disaster and other public health emergencies. Within ASPR, the Biomedical Advanced Research and Development Authority (BARDA) invests in innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products – needed to combat health security threats. BARDA is one of the leading public sector funders of advanced development of antimicrobial therapeutics and diagnostics worldwide, having invested more than $2.4 billion in antimicrobial products since 2010. This investment has supported the development of over 160 antimicrobial products and led to the U.S. Food and Drug Administration (FDA) approval of four new antibiotics and FDA 510(k) clearance of eight diagnostics.
About Wellcome
Wellcome supports science to solve the urgent health challenges facing everyone. We support discovery research into life, health and wellbeing, and we’re taking on three worldwide health challenges: mental health, infectious disease and climate and health.
About the German Federal Ministry of Education and Research (BMBF)
Education and research are crucial foundations for our future. Thus, the promotion of education, science and research is a policy priority of the German Federal Government. The German Federal Ministry of Education and Research (BMBF) strengthens education at all stages of life and provides support for scientific research and innovation.
About the Global AMR Innovation Fund (GAMRIF)
The Global AMR Innovation Fund (GAMRIF) is a One Health aid fund that supports research and development around the world to reduce the threat of antimicrobial resistance (AMR) in humans, animals and the environment for the benefit of people in low- and middle-income countries (LMICs). GAMRIF core objectives are to develop innovative One Health solutions to tackle AMR; increase availability of context-specific, accessible, and affordable innovations for LMICs; establish international research partnerships with industry, academia, and governments; and collaborate with and leverage additional funding from other global donors.
About the Public Health Agency of Canada
The Public Health Agency of Canada is an agency of the Government of Canada that is responsible for public health, emergency preparedness and response, and infectious and chronic disease control and prevention. Created in 2004 with a mission to promote and protect the health of Canadians through leadership, partnership, innovation and action in public health, the Agency’s activities focus on preventing disease and injuries, responding to public health threats, promoting good physical and mental health, and providing information to support informed decision making. The Agency has a long history of working with domestic and international partners on combatting health threats, including AMR. Most recently, the Agency released the Pan-Canadian Action Plan on AMR, a multijurisdictional effort that emphasizes One Health collaboration to make progress on AMR.
About the Novo Nordisk Foundation
Established in Denmark in 1924, the Novo Nordisk Foundation is an enterprise foundation with philanthropic objectives. The vision of the Foundation is to improve people’s health and the sustainability of society and the planet. The Foundation’s mission is to progress research and innovation in the prevention and treatment of cardiometabolic and infectious diseases as well as to advance knowledge and solutions to support a green transformation of society.
About Boston University
Founded in 1839, Boston University is an internationally recognized institution of higher education and research. With nearly 37,000 students, it is one of the largest private residential universities in the United States. BU consists of 17 schools and colleges, along with the Faculty of Computing & Data Sciences and a number of multi-disciplinary centers and institutes integral to the University’s research and teaching mission. In 2012, BU joined the Association of American Universities (AAU), a consortium of leading research universities in the United States and Canada. For further information, please contact Kim Miragliuolo at kmira@bu.edu. www.bu.edu