Partnership to explore clinical needs and market barriers for drug-resistant Neisseria gonorrhea interventions in low- and middle-income countries
(BOSTON: November 26, 2024) – Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) and the Clinton Health Access Initiative (CHAI) are partnering to evaluate the clinical needs and address market barriers for diagnostic, preventative, and therapeutic interventions targeting gonorrhea infections in low- and middle-income countries.
Gonorrhea is the second most prevalent sexually transmitted infection (STI) in the world after chlamydia and is caused by the bacterium Neisseria gonorrhoeae (N. gonorrhoeae). Approximately 82 million people around the world are affected by the disease, with the highest prevalence in Africa. Patients with gonorrhea can face serious health effects, including a five-fold increase in HIV transmission, pelvic inflammatory disease, chronic pelvic pain, and infertility.
Since patients do not always exhibit symptoms, reported cases may only capture a fraction of the true burden. While gonorrhea is treatable with some antibiotics, the emergence of antibiotic-resistant strains of N. gonorrhea makes treatment more challenging.
The two-year partnership between CHAI and CARB-X will start with a clinical needs assessment that builds upon previous work in this space, including FIND’s market analyses for point-of-care diagnostics for gonorrhea in resource-constrained countries. The partnership aims to develop a clear understanding of which solutions to prioritize, implementation hurdles, and how to move toward sustainable markets for AMR-focused interventions in LMICs.
Initial market assessments will focus on drug-resistant N. gonorrhoeae as a single pathogen. This approach will enable CHAI to leverage its previous work on STIs in the region. CARB-X will use this intelligence to develop a CARB-X portfolio company including diagnostics, preventatives, and therapeutics.
CARB-X and CHAI will work closely with eight LMIC countries to conduct the evaluation. They will carry out the assessment through surveys and focused interviews to deepen the understanding of how novel interventions, such as rapid gonorrhea and chlamydia tests, including susceptibility testing, might be used to better inform patient management. Considering the high levels of antibiotic resistance across countries in the region, this research can be used to guide the introduction of new diagnostics and treatments for gonorrhea into the market, both within the CARB-X portfolio and outside of it. Additionally, the research will gather user preferences for gonorrhea vaccines and therapeutics. The study also will assess market barriers, such as limited funding, outdated clinical guidelines, complex regulatory pathways for low- and middle-income-focused products, and ultimately, propose solutions to increase access.
“We are excited to embark on this initial body of work with CHAI, leveraging their experience in market assessment and thoughtful implementation of interventions for HIV and other STIs in LMICs over the past 20 years,” said CARB-X Chief of R&D Erin Duffy, PhD. “Our goal is to build off work done by others in this space, such as FIND and the Global Antibiotic Research & Development Partnership (GARDP) and share our learnings broadly so that all entities working toward gonorrhea-focused interventions can provide meaningful solutions where they are needed the most.”
N. gonorrhoeae is a priority for CARB-X due to the high global burden of the disease, related morbidity, and global rise of multidrug- and extremely-drug-resistant gonorrhea. The bacteria that causes the disease has become resistant to antibiotics in all classes and antibiotics therein that were previously effective, with the exception of ceftriaxone.
Additionally, a new therapeutic for treating gonorrhea has been difficult to bring to market. If one or more of the novel agents in development make it to market, it will be important to ensure the new treatments are effective for as long as possible, prioritizing patients with drug-resistant gonorrhea while continuing to use existing therapies in other patients. Importantly, there is no vaccine for gonorrhea, nor are there reliable, rapid diagnostic tests. This has also contributed to the rise in antibiotic resistance.
“Partnering with CARB-X allows us to enhance our understanding of AMR and align our efforts to combat drug-resistant infections,” said Dr. David Ripin, CHAI Executive Vice President, Infectious Diseases, Chief Science Officer. “This collaboration will help us shape impactful strategies to address the growing public health threat posed by AMR, particularly in regions with the highest need.”
Notes for media
Since 2017, CARB-X has supported several antibacterial products to address N. gonorrhoeae, including advancing the development of one therapeutic, three preventatives, and five diagnostics. Active projects include those from product developers across the pillars of treatment (Debiopharm), prevention (University of Oxford’s Jenner Institute, LimmaTech, Intravacc) and diagnosis (SpeeDx, Visby Medical, , Prompt, Fuse, and Scout).
CHAI is uniquely positioned to be a strong partner to drive change in the AMR space: as a market shaper, driving down the price of drugs while increasing access; as a trusted government partner, helping to build strong health policies; as an operational partner, turning those policies into action; and importantly, as an ecosystem catalyst, leveraging the strength of partners across sectors to bring about transformational impact. In collaboration with CARB-X, CHAI aims to apply its expertise and expand its impact in the antimicrobial resistance space to address this growing public health threat.
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 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
CHAI Contact: Corina Milic cmilic@clintonhealthaccess.org
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 the Clinton Health Access Initiative
The Clinton Health Access Initiative (CHAI) is a global health organization committed to saving lives and improving health outcomes in low- and middle-income countries by enabling the government and private sector to strengthen and sustain quality health systems. For more information, please visit www.clintonhealthaccess.org.
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.
As part of HHS, NIH is the primary U.S. 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 better understand, treat, and ultimately prevent infectious, immunologic and allergic diseases. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.
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 the third-largest independent university in the United States. BU consists of 17 schools and colleges and the interdisciplinary Faculty of Computing & Data Sciences, 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 71 leading research universities in the United States and Canada. For further information, please contact Kim Miragliuolo at kmira@bu.edu. www.bu.edu