(BOSTON: February 6, 2019) – CARB-X, a Boston University global partnership, is awarding Recida Therapeutics of Menlo Park, CA, USA, up to $4.4 million in non-dilutive funding to develop a novel antibiotic to treat serious infections caused by Gram-negative bacteria.
“The world urgently needs new classes of antibiotics and other life-saving products to prevent, diagnose, and treat deadly infections,” said Kevin Outterson, Executive Director of CARB-X and Boston University law professor. “Recida’s lead program inhibits LpxC, and would represent a new drug class against Gram-negative superbugs, if approved by the FDA. The projects in the Powered by CARB-X portfolio are in early development, but if successful, they offer tremendous hope in the global fight against drug-resistant bacteria.”
“We are very excited and most appreciative of the CARB-X award.” said James Ge, M.D., Ph.D., CEO of Recida. “Support from CARB-X significantly enhances our ability to take critical steps in the clinical development of this potentially life-saving antibiotic.”
The CARB-X award will help fund preparation of an Investigational New Drug (IND) application for RC-01 for submission to the US Food and Drug Administration (FDA), and if successful, a Phase 1 trial to be completed in 2019 and drug product manufacturing to support subsequent clinical trials.
In preclinical testing, RC-01 has shown ability to inhibit LpxC, a key enzyme in Lipid A biosynthesis and essential component of the protective outer membrane of Gram-negative bacteria. LpxC is a validated target in Gram-negative bacteria, but there are no approved therapeutics targeting LpxC; past efforts have failed often as a result of poor drug-like properties or toxicity. Recida was launched by Frazier Healthcare Partners to advance RC-01, recently licensed from FUJIFILM Toyama Chemical Co., to Phase 1 clinical trials. In testing, RC-01 has shown a promising safety profile and potent activity against Enterobacteriaceae and Pseudomonas aeruginosa.
Enterobacteriaceae and P. aeruginosa are Gram-negative pathogens. They are among the world’s deadliest superbugs and often cause difficult-to-treat hospital-acquired infections. Patients whose care requires devices like ventilators, urinary catheters or intravenous catheters are most at risk for these types of infections.
New antibiotics, diagnostics and other products are needed urgently to treat bacteria that are increasingly resistant to existing antibiotics. According to the World Health Organization (WHO), an estimated 700,000 people die each year worldwide from bacterial infections. In the United States, an estimated 23,000 people die each year from drug-resistant bacterial infections, according to the US Centers for Disease Control and Prevention (CDC).
CARB-X’s expanding portfolio
The Recida project brings to 12 the number of projects in the CARB-X portfolio focused on new classes of antibiotics. CARB-X is supporting 34 innovative projects world-wide and expects that number to increase significantly this year. Since it was established in 2016, CARB-X has announced awards exceeding $107.4 million, plus 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. In total since it was established, CARB-X has announced awards for 41 projects.
Partnership to drive antibacterial innovation globally
CARB-X is a Boston University global partnership funded by the US Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA), the Wellcome Trust, the UK Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund, and the Bill & Melinda Gates Foundation, 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 in antibacterial R&D between 2016-2021. The goal is to support projects through the early phases of development through Phase 1, so that they will attract additional private or public support for further clinical development and approval for use in patients. The scope of CARB-X funding is restricted to projects that target drug-resistant bacteria highlighted on the CDC’s 2013 Antibiotic Resistant Threats list, or the Priority Bacterial Pathogens list published by the WHO in 2017 – with a priority on those pathogens deemed Serious or Urgent on the CDC list or Critical or High on the WHO list.
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 Administration for Strategic Preparedness and Response, Wellcome Trust, or other CARB-X funders.
Media Contacts:
CARB-X:
Jennifer Robinson carbxpr@bu.edu
M: +1.514.914.8974
Recida Therapeutics / Frazier Healthcare Partners:
Liz Park liz.park@frazierhealthcare.com
T: +1.650.319.1831
About CARB-X
CARB-X is a Boston University global partnership dedicated to accelerating early development antibacterial R&D to address the rising global threat of drug-resistant bacteria. CARB-X funding is provided by US Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR), the Wellcome Trust, a global charity based in the UK working to improve health globally, the UK Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (UK GAMRIF), the Bill & Melinda Gates Foundation, with in-kind support from National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH). A non-profit partnership, CARB-X is investing up to $500+ million from 2016-2021 to support innovative antibiotics and other therapeutics, vaccines, rapid diagnostics and devices. CARB-X supports the world’s largest and most innovative pipeline of preclinical products against drug-resistant infections. CARB-X focuses exclusively on high priority drug-resistant bacteria, especially Gram-negatives. CARB-X is based at Boston University School of Law. https://carb-x.org/. Follow us on Twitter @CARB_X.
About Frazier Healthcare Partners
Founded in 1991, Frazier Healthcare Partners is a leading provider of growth and venture capital to healthcare companies. With nearly $4.2 billion total capital raised, Frazier has invested in over 170 companies, with investment types ranging from company creation and venture capital to buyouts of profitable lower-middle market companies. The firm’s Growth Buyout team invests in healthcare and pharmaceutical services, medical products and related sectors. The Life Sciences team invests in therapeutics and related areas that are addressing unmet medical needs through innovation. Frazier has offices in Seattle, WA and Menlo Park, CA, and invests broadly across the US, Canada, and Europe. For more information about Frazier Healthcare Partners, visit the company’s website at www.frazierhealthcare.com.
About Recida Therapeutics
Recida Therapeutics is an emerging clinical-stage biotechnology company focused on developing first-in-class anti-infective medicines for the treatment of multi-drug resistant infections. The company is currently advancing its novel LpxC inhibitor, RC-01, into Phase 1 clinical trials. Recida is led by an experienced team of pharmaceutical and anti-infectives executives seeking to improve outcomes for patients with multi-drug resistant and other difficult-to-treat infections. Recida is located in Menlo Park, CA. www.recidatherapeutics.com
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)
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 visit www.bu.edu.