Peptilogics’ engineered cationic antibiotic peptide is designed to kill multi-drug-resistant bacteria rapidly, transforming the way prosthetic joint infections (PJI) are treated
(BOSTON) – CARB-X is awarding Peptilogics, headquartered in Pittsburgh, USA, up to US$2.56 million in non-dilutive funding to develop a new class of peptide antibiotics with broad activity against drug-resistant bacteria. The company could receive up to $9.61 million more in additional funding if the project achieves certain development milestones, for a potential total of up to $12.17 million.
The initial application of the new antibiotic would be towards serious infections associated with implants such as prosthetic knees and hips. CARB-X funding will support the development of Peptilogics’ lead compound PLG0206, including the filing of a US Food and Drug Administration (FDA) Investigational New Drug (IND) Application and Phase 1 clinical trial.
“Joint replacements are an increasingly common surgical procedure, and infections are the most serious and costly complication of joint replacements,” said Erin Duffy, Chief of Research and Development of CARB-X, which is based at Boston University School of Law. “The Peptilogics project has exhibited activity against critical ESKAPE pathogens. The project is still in the early phases of development, but if successful and approved for use in patients, it could represent tremendous improvement in the treatment of periprosthetic joint infections.”
The number of joint replacements around the world is growing every year as the population ages. In the US alone, more than 1 million total joint replacements are performed annually, a number expected to grow to 4 million procedures by 2030, according to a study for the American Academy of Orthopaedic Surgeons, with similar trends observed in the European Union and Asia Pacific region. Following joint replacement, an estimated one to two percent of patients develop infections. Currently, there are few treatment options and major surgery is required to attempt to resolve the infection. Current standard of care PJI treatment has a high failure rate, is costly, and often requires additional follow-on surgical interventions, including complete replacement of the prosthesis. These additional procedures lead to substantial morbidity and mortality, with a 20 percent 5-year mortality risk, according to recent studies.
Jonathan Steckbeck, Founder and CEO of Peptilogics, said: “These funds will support further development of PLG0206, our lead compound that has demonstrated broad-spectrum activity against pathogens identified by WHO and CDC as critical, urgent, or high priority targets. We are honored to be partnering with CARB-X in working to address the current crisis in drug-resistant infections, which we believe is one of the most serious and acute issues affecting modern medicine and global public health.”
PLG0206 was developed with Peptilogics’ novel peptide design platform, using a proprietary algorithmic process to optimize activity characteristics, leading to a good safety profile in animals and potent broad-spectrum antibacterial activity against clinically-important MDR Gram-positive (Staphylococcus aureus, including MRSA, and Enterococcus faecium, including VRE) and Gram-negative (Pseudomonas aeruginosa, Escherichia coli, and Acinetobacter baumannii) pathogens. In addition, PLG0206 exhibits the ability to disrupt biofilms, making it an ideal candidate for treatment of biofilm-associated infections. PLG0206 sterilized implant materials following a short exposure in a biofilm model, suggesting that it could rapidly kill implant-associated biofilm bacteria in a clinical setting.
Peptilogics’ program has been granted Qualified Infectious Disease Product (QIDP) status by the FDA, which provides certain incentives for the development of new antibiotics, including an additional five years of market exclusivity, as well as eligibility for Priority Review and Fast Track designation.
Supporting innovation to address the global superbug crisis
CARB-X is led by Boston University and funded by a global partnership. CARB-X is investing up to $500 million between 2016-2021 to support the development of new antibiotics, rapid diagnostics, vaccines and other life-saving products. The goal is to support projects through the early phases of development – through Phase 1 for therapeutics – so that they will attract additional private or public support for further clinical development and approval for use in patients.
The CARB-X portfolio is the world’s largest antibacterial development portfolio with 38 active projects in five countries. Since its launch in 2016, CARB-X has announced 58 awards exceeding $195.6 million, with the potential of additional funds if project milestones are met, to accelerate the development of antibacterial products. These funds are in addition to investments made by the companies themselves. The CARB-X pipeline will continuously evolve, as projects progress and others fail for a variety of reasons.
This news release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by an award from Wellcome Trust. The contents are solely the responsibility of the authors and do not necessarily represent the official views of the HHS Office of the Assistant Secretary for Preparedness and Response, or other CARB-X funders.
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Caroline Rufo, PhD
Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) is a global non-profit partnership dedicated to accelerating early development antibacterial R&D to address the rising global threat of drug-resistant bacteria. CARB-X is led by Boston University and funding is provided by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the US Department of Health and Human Services , the Wellcome Trust, a global charity based in the UK working to improve health globally, 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 Bill & Melinda Gates Foundation, and with in-kind support from National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH). CARB-X is investing up to $500 million from 2016-2021 to support innovative antibiotics and other therapeutics, vaccines, and rapid diagnostics . CARB-X supports the world’s largest and most innovative pipeline of preclinical products against drug-resistant infections. CARB-X is headquartered at Boston University School of Law. carb-x.org/. Follow us on Twitter @CARB_X.
Peptilogics is a clinical-stage biotechnology platform company discovering and developing novel peptide therapeutics for critical unmet medical needs. The company’s first focus is to provide solutions for the current crisis of drug-resistant bacterial infections, which kill more than 700,000 people globally each year, according to a 2016 United Kingdom government study. Peptilogics’ anti-infective program focuses on compounds derived from their proprietary computational design platform that have demonstrated novel mechanisms of action for the treatment of multidrug-resistant infections. Using rational, statistical and algorithmic design principles, the technology amplifies antimicrobial activity while also achieving a strong safety profile, generating broad- and narrow-spectrum antibiotics that demonstrate a substantially lower risk of generating drug resistance than existing solutions. More information on Peptilogics can be found at www.peptilogics.com as well as on Twitter (www.twitter.com/peptilogics; @Peptilogics) and LinkedIn (www.linkedin.com/company/peptilogics).
About BARDA and NIAID
The US 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. Within HHS, ASPR’s mission is to save lives and protect Americans from 21st century health security threats. ASPR leads the nation’s medical and public health preparedness for, response to, and recovery from disasters and public health emergencies. BARDA provides a comprehensive, integrated, portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear agents, pandemic influenza, and emerging infectious diseases. NIH is the primary US federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses.
About Wellcome Trust
Wellcome exists to improve health for everyone by helping great ideas to thrive. We’re a global charitable foundation, both politically and financially independent. We support scientists and researchers, take on big problems, fuel imaginations and spark debate. The Wellcome Trust is a charity registered in England and Wales, no. 210183. Its sole trustee is The Wellcome Trust Limited, a company registered in England and Wales, no. 2711000 (whose registered office is at 215 Euston Road, London NW1 2BE, UK).
Education and research are the foundations for our future. The promotion of education, science and research by the Federal Ministry of Education and Research (BMBF) represents an important contribution to securing Germany’s prosperity. Education and research are a Federal Government policy priority, which is reflected in the development of the funding it is making available to these fields.
About the Global AMR Innovation Fund (GAMRIF)
The Department for Health and Social Care (DHSC) is the UK Government department which is responsible for helping people to live more independent, healthier lives for longer.
The partnership with CARB-X is part of DHSC’s Global Antimicrobial Resistance Innovation Fund (GAMRIF). GAMRIF was established to provide seed funding for innovative research and development, specifically in neglected and underinvested areas, in the field of AMR. GAMRIF is a £50m UK Aid investment, which means all projects funded must support research primarily and directly for the benefit of people in low- and middle-income countries (LMICs). The Fund takes a ‘One Health’ approach, seeking to invest in potential solutions to reduce the threat of AMR in humans, animals, fish and the environment. The Fund seeks to leverage additional global funding through interaction with international government bodies, public-private partnerships, product development partnerships, global funding mechanisms and global fora.
About Boston University
Founded in 1839, Boston University is an internationally recognized institution of higher education and research. With more than 33,000 students, it is the fourth-largest independent university in the United States. BU consists of 17 schools and colleges, along with 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 62 leading research universities in the United States and Canada. For further information, please contact Jeremy Thompson at firstname.lastname@example.org. www.bu.edu.