Amicrobe launches new development program for infection prevention in low- and middle-income countries (LMIC), and advances its surgery and trauma antimicrobial project
(BOSTON: June 22, 2020) – CARB-X announced today it is awarding US$4.6M to Amicrobe Inc. to expand development of its bioengineered Amicidin-β synthetic protein designed to kill bacteria and cleanse tissues. The new funding will help accelerate IND-enabling work on Amicidin-β Solution, which targets treatment of serious surgical and traumatic wound infections, and will also support prototyping of a new product for prevention of infection in low- and middle-income countries (LMIC).
Under the LMIC program, Amicrobe is designing and prototyping Amicidin-β/EF (extended formulation). This new formulation of Amicidin-β, perhaps as a foam, targets ease of use and climate-zone stability in parts of the world where cold storage systems are not always available for healthcare products. Rapid, effective tissue coverage is also a critical design goal. Funding for the LMIC product is made possible by the UK Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (GAMRIF), a CARB-X partner that supports early-stage innovative research in underfunded areas of R&D to tackle antimicrobial resistance (AMR) for the benefit of people in LMICs.
The funds announced today are in addition to $6.2 million awarded by CARB-X in 2017 to support the development of Amicrobe’s innovative Amicidin-β Solution through a Phase 1 clinical trial. This product is designed for direct application to contaminated and infected tissues in surgical and emergency settings, including in the management of hip and knee prosthetic joint infections. The new funding will help accelerate IND-enabling studies focused on orthopedic hardware-related infections, and an IND submission to the Food and Drug Administration (FDA).
“Superbugs do not stop at borders. We know that life-threatening pathogens, like viruses and drug-resistant bacteria, can affect human health everywhere in the world – people rich and poor, young and old,” said Erin Duffy, Chief of Research and Development of CARB-X. “At CARB-X, our strategy is to support multiple innovative R&D approaches to prevent, diagnose and treat drug-resistant bacterial infections. Every project in the CARB-X portfolio has the potential to make progress against the global threat of drug resistance.”
“The threat of antimicrobial resistance challenges all of us to bring forward new technologies and innovative products to prevent and treat life-threatening infections,” said Michael P. Bevilacqua, M.D., Ph.D., CEO and CSO at Amicrobe, a Carlsbad, CA-based firm. “Amicrobe is grateful to CARB-X and its funding partners for enabling the advancement of our Amicidin-β programs, which we believe have the potential to save lives and curb the spread of drug-resistant bacteria in our own communities and around the world.”
Urgent need to prevent and treat life-threatening infections
Amicrobe’s Amicidin-β project stands out as the only topical antimicrobial in the CARB-X portfolio. Designed to attack microbes locally at the site of infection, Amicidin-β combines broad, rapid microbicidal activity with beneficial physical properties to treat and prevent drug-resistant bacterial infections.
Dr. Bevilacqua said the idea to develop a version of Amicidin-β for LMICs came from Dr. Joseph S. Solomkin, the company’s Chief Medical Officer. Through his international research activities in sub-Saharan Africa and elsewhere, Dr. Solomkin sees an urgent need in developing nations for better protection for women who deliver through caesarean section.
Caesarean delivery represents more than 50% of surgical procedures in sub-Saharan Africa, most of which are performed on an emergency basis. Up to 20% of these mothers can develop infections, compromising their own health and ability to care for their babies.
Surgical site infections threaten the lives of millions of patients each year and contribute to the spread of antibiotic resistance. In LMICs, an estimated 11% of patients who undergo surgery are infected in the process. Surgical site infections are not a problem just in developing countries. In the United States, for example, more than 1 million joint replacement surgeries are performed annually and an estimated 1 to 2% of these patients develop infections following joint replacement surgery.
Effective locally applied products to help prevent and treat surgical site drug-resistant infections and infections of traumatic injuries could be beneficial throughout the world.
Of the new funding announced today, $2.76M will help support further development of Amicidin-β Solution and IND submission; $1.84M is earmarked for the Amicidin-β/EF (extended formulation). If the LMIC program advances successfully, CARB-X may consider additional support for IND-enabling studies and a Phase 1/2a clinical trial.
Innovation to fight the rise of drug-resistant bacteria
Drug-resistant infections cause an estimated 700,000 deaths worldwide annually, according to the World Health Organization. In the US, the Centers for Disease Control and Prevention (CDC) estimates that 35,000 people die each year from drug-resistant bacterial infections, many of which occur in hospitals and healthcare settings.
CARB-X funds and supports a scientifically diverse portfolio of early development therapeutics, vaccines and rapid diagnostics focused on the most serious drug-resistant bacterial infections. There are currently 41 active projects in the CARB-X portfolio. The goal is to support projects through the early phases of development so that they will attract additional private or public support for further clinical development and approval for use in patients.
Since its launch in 2016, CARB-X has announced 63 awards exceeding $236.72 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 awards from Wellcome Trust, Germany’s Federal Ministry of Education and Research (BMBF), and the UK Global Antimicrobial Resistance Innovation Fund (GAMRIF). The contents are solely the responsibility of the authors and do not necessarily represent the official views of the HHS Administration for Strategic Preparedness and Response, or other CARB-X funders.
Vice President of Operations
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 Administration for Strategic 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.
About Amicrobe Inc.
Amicrobe engineers proteins to prevent and treat bacterial, fungal, and viral infections. Amicrobe’s technology platform produces synthetic proteins that combine broad microbicidal activity, beneficial physical properties, and safety to enable local application to prevent and treat life-threatening infections, especially in the fields of surgery and trauma. Amicrobe’s leading programs include Amicidin-α and Amicidin-β, potential innovations in the fight against antibiotic resistance. Amicrobe is headquartered in Carlsbad, California. For more information, visit Amicrobe at www.amicrobe.com.
About Amicrobe’s Amicidin-β program
Amicidin-β is a novel biological therapeutic (single chain amino acid polymer) that combines microbicidal activity and surfactant properties within the same molecule for enhanced intrawound performance. Built by iterative design and testing, Amicidin-β is being developed for treatment of life-threatening focal infections, especially those involving foreign bodies and biofilms. High-impact applications may include infections associated with orthopedic implants, surgical procedures, and traumatic wounds. Amicidin-β is produced using robust polymer methods, which should enable large-scale, cost-effective manufacturing. It is protected by multiple US and international issued and pending patents.
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.