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CARB-X partners with MicuRx to develop a polymyxin antibiotic to treat multi-drug resistant Gram-negative superbugs including E. coli, P. aeruginosa, K. pneumoniae and A. baumannii

CARB-X partners with MicuRx to develop a polymyxin antibiotic to treat multi-drug resistant Gram-negative superbugs including E. coli, P. aeruginosa, K. pneumoniae and A. baumannii

MicuRx Project Brings to 25 the Number of Projects in the Powered By CARB-X Portfolio

(BOSTON, MA) – March 5, 2018 – CARB-X is teaming up with MicuRx Pharmaceuticals Inc. of Hayward, CA, to support the early development of its polymyxin antibiotic MRX-8 to treat the most serious multi-drug-resistant bacterial infections, including infections caused by Gram-negative pathogens E. coli, P. aeruginosa, K. pneumoniae and A. baumannii. Under the agreement, MicuRx will receive an initial award of up to $2.5 million from CARB-X, with the possibility of $2.7 million more based on the achievement of certain project milestones.

“The MicuRx project is an important addition to the CARB-X portfolio, bringing diversity and advancing knowledge on serious issues related to toxicity. The world urgently needs new antibiotics and entirely new approaches to protect us from drug-resistant bacteria,” said Kevin Outterson, Executive Director of CARB-X. “The projects in the Powered by CARB-X portfolio are in the early stages of research, and there is always a risk of failure. But if successful, these innovative projects hold great potential in the treatment of serious infections and in the fight against the rise of drug-resistant bacteria.”

“We are pleased to have received this support for our MRX-8 program from CARB-X, a non-profit partnership comprised of the key global leaders in the science, development, and the medical use of anti-infectives,” said Zhengyu Yuan, Ph.D., president and CEO of MicuRx. “Gram-negative pathogens such as Klebsiella pneumoniae and Pseudomonas aeruginosa are one of the leading cause of hospital-acquired infections throughout the world. These infections represent an unmet medical need we are targeting with our new clinical candidate MRX-8.”

The antibacterial class of polymyxins includes the drugs colistin and polymyxin B, essential antibiotics with potent activity against Gram-negative pathogens. While very effective, polymyxins are relegated to a last-resort option due to the high incidence of kidney toxicity (nephrotoxicity), with rates up to 60% for the current polymyxin therapy. In addition to nephrotoxicity, polymyxins can manifest neurotoxicity. Due to the lack of agents effective against multi-drug resistant infections, physicians are increasingly using polymyxins, despite the toxicity. Importantly, no novel systemic polymyxin has been approved in over 60 years.

The novel agent MRX-8 originated at MicuRx and is designed to overcome the limiting nephrotoxicity of current polymyxins. Current preclinical data demonstrated its high efficacy, with the reduced nephrotoxicity as well as attenuated acute or neuromuscular toxicity, when compared to existing polymyxin drugs.

The world urgently needs new antibiotics to treat drug-resistant bacteria. According to the World Health Organization (WHO), an estimated 700,000 people die each year around the world from bacterial infections – and that number is on the rise. In the US alone, 23,000 people die each year from drug-resistant bacterial infections, according to the Centers for Disease Control and Prevention (CDC).

CARB-X, which stands for Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, funds projects in 6 countries (France, India, Ireland, Switzerland, United Kingdom, United States) and is working to expand its pipeline with the best science from around the world.

The CARB-X portfolio is the world’s largest and most scientifically diverse portfolio of early development antibacterial projects with 8 new classes of antibiotics under investigation and 25 projects in all including therapeutics, vaccines and diagnostics to respond to the threat of drug-resistant bacteria.

Since it was established in July 2016, CARB-X has announced awards totaling $67.14 million, plus an additional $84.12 million if project milestones are met, to accelerate the development of antibiotics and other products. These funds are in addition to investments by the companies. CARB-X is planning further funding announcements later this year.

CARB-X is a partnership between the UK charity Wellcome Trust and the US Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR), and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). CARB-X is actively seeking global support from other governments, industry and civil society to expand its ability to fund the best science around the world to get the new life-saving treatments so urgently needed.

BARDA’s Director Rick Bright, PH.D., said: “The support announced today aims to speed development of a novel and potentially safer alternative to the current polymyxin antibiotics, to ensure we can treat patients with life-threatening infections and enhance national security and global health security. At BARDA, we are committed to revitalizing the antibacterial pipeline through a combination of incentives. Today’s announcement is another example of our commitment to promote and accelerate medical countermeasure innovation through novel public-private partnerships like CARB-X.”

Tim Jinks, Head of Drug-Resistant Infections at Wellcome Trust, said: “Wellcome is committed to addressing this urgent global health threat. With drug-resistant infections spreading rapidly it’s vital we speed discovery of new and innovative treatments. The addition of this exciting project to the CARB-X portfolio is another important step in achieving this. Drug discovery must also go hand-in-hand with concerted action to ensure responsible use of antibiotics and availability of existing and new treatments for patients in all countries.”

Additionally, the CARB-X partnership leverages NIAID’s long-standing preclinical services program established to facilitate product development for new drugs, vaccines and diagnostics. CARB-X is representative of the innovative new types of strategies encouraged by NIAID in recent years.

CARB-X funding is part of an overall commitment of up to US$455m by the US government and Wellcome Trust over a five-year period from 2016-2021.

CARB-X identifies and funds promising early development research to treat the most serious bacteria. The goal is to support projects through the early phases so that they will attract additional private or public support for clinical development. To be considered for CARB-X support, projects must target antibiotic resistant bacteria on the Serious or Urgent Threat List prepared by the CDC or on the Priority Pathogens list published by the WHO.

This news release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by an award from Wellcome Trust, as administrated by CARB-X. The contents are solely the responsibility of the authors and do not necessarily represent the official views of CARB-X, the HHS Office of the Assistant Secretary for Preparedness and Response, the National Institutes of Health or Wellcome Trust.

Media Contacts:

CARB-X: Jennifer Robinson
(514) 914-8974; carbxpr@bu.edu

MicuRx: Zhengyu Yuan, Ph.D.
President and CEO
MicuRx Pharmaceuticals, Inc.
Phone: (+1) 510-782-2021
zyuan@micurx.com

Angela Bitting
For MicuRx Pharmaceuticals, Inc.
(925) 202-6211
a.bitting@comcast.net

About CARB-X

CARB-X is one of the world’s largest public-private partnership devoted to early development antibacterial R&D. Funded by ASPR/BARDA and Wellcome Trust, with in-kind support from NIAID, CARB-X is investing up to $455 million from 2016-2021 to support innovative therapeutics, vaccines, rapid diagnostics and devices to treat drug-resistant bacterial infections. CARB-X focuses on high priority drug-resistant bacteria, especially Gram-negatives. CARB-X operates through Boston University. Other partners include RTI International, the Broad Institute of Harvard and MIT, MassBio, and the California Life Sciences Institute (CLSI). http://www.carb-x.org/..

About MicuRx Pharmaceuticals, Inc.

MicuRx is a privately-held biopharmaceutical company whose mission is to discover and develop effective antibiotics with improved safety to enhance the treatment of serious bacterial infections. Its lead compound, MRX-1 is a next-generation oxazolidinone targeting Gram-positive infections such as methicillin-resistant S. aureus (MRSA). The agent is designed to reduce hematological adverse events of this antibiotic class. MicuRx has completed two independent Phase 2 studies in the US and China for MRX-1 in 2015, and initiated Phase 3 study in China in 2016 for treatment of complicated skin and skin structure infections (cSSSI). The company has research and development facilities outside San Francisco, CA in the United States, and in Shanghai, China. The company has raised a total of $100 million through leading venture capital firms including Morningside Ventures, BVCF, GP Healthcare Capital, GP TMT Capital, 3E Bioventures Capital, and Delian Capital. Visit www.micurx.com for more information.

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 HHS, ASPR and NIH

HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.

ASPR’s mission is to save lives and protect Americans from 21st century health security threats. ASPR leads the federal public health and medical preparedness and response to disasters and other emergencies, on behalf of the Secretary of HHS. Within ASPR, BARDA provides a comprehensive integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear threat agents, pandemic influenza, and emerging infectious diseases.

NIAID is one of the 27 Centers and Institutes of the National Institutes of Health (NIH) a component of the U.S. Department of Health and Human Services. NIH is the nation’s medical research agency, and is the primary 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. For more information about NIH and its programs, visit www.nih.gov. News releases, fact sheets and other NIAID-related materials are available on the NIAID website: https://www.niaid.nih.gov.

About Boston University

A leading research university with over 33,000 undergraduate and graduate students from more than 130 countries, nearly 10,000 faculty and staff, 17 schools and colleges, and 250 fields of study. Boston University is consistently ranked among the world’s best research universities and is a member of the American Association of Universities. For further information, see www.bu.edu or contact Ann Comer-Woods anncomer@bu.edu

About the Broad Institute of MIT and Harvard

Broad Institute of MIT and Harvard was launched in 2004 to empower this generation of creative scientists to transform medicine. The Broad Institute seeks to describe all the molecular components of life and their connections; discover the molecular basis of major human diseases; develop effective new approaches to diagnostics and therapeutics; and disseminate discoveries, tools, methods, and data openly to the entire scientific community. Founded by MIT, Harvard, Harvard-affiliated hospitals, and the visionary Los Angeles philanthropists Eli and Edythe L. Broad, the Broad Institute includes faculty, professional staff, and students from throughout the MIT and Harvard biomedical research communities and beyond, with collaborations spanning over a hundred private and public institutions in more than 40 countries worldwide. For further information about the Broad Institute, http://www.broadinstitute.org. In support of CARB-X, the Broad Institute created the Collaborative Hub for Early Antibiotic Discovery (CHEAD), which serves an interdisciplinary center that partners with academic investigators engaged in antibiotic development and/or resistance research to accelerate their early-stage, small molecule therapeutics toward Investigational New Drug (IND) application.

About MassBio

MassBio is a not-for-profit organization founded in 1985 that represents and provides services and support for the world’s leading life sciences supercluster.

MassBio is committed to advancing Massachusetts’ leadership in the life sciences to grow the industry, add value to the healthcare system and improve patient lives.

Representing 1000+ biotechnology companies, academic institutions, disease foundations and other organizations involved in life sciences and healthcare, MassBio leverages its unparalleled network of innovative companies and industry thought leaders to advance policy and promote education, while providing member programs, events, industry information, and services. Learn more at MassBio

About the California Life Sciences Institute (CLSI)

The mission of the California Life Sciences Institute (CLSI) is to maintain California’s leadership in life sciences innovation through support of entrepreneurship, education and career development. Located in the birthplace of biotechnology, CLSI strives to ensure that the economic and intellectual power of the region’s life sciences industry and its employees remains strong. By maintaining its focus on entrepreneurship, education and career development programs, CLSI supports the foundations of innovation that have made California home to the world’s most prominent life sciences ecosystem. As a non-profit 501(c)(3), CLSI’s objectives are met through collaborations, partnerships, and the generosity of individuals, sponsors and foundations. CLSI is a member of the CARB-X consortium, serving as an accelerator. Learn more at http://califesciencesinstitute.org.

About RTI International

RTI International is an independent, nonprofit research institute dedicated to improving the human condition. Clients rely on us to answer questions that demand an objective and multidisciplinary approach—one that integrates expertise across the social and laboratory sciences, engineering, and international development. We believe in the promise of science, and we are inspired every day to deliver on that promise for the good of people, communities, and businesses around the world. For more information, visit www.rti.org.