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CARB-X partners with Macrolide Pharmaceuticals to develop novel macrolide antibiotics with Gram-negative activity

CARB-X partners with Macrolide Pharmaceuticals to develop novel macrolide antibiotics with Gram-negative activity

(BOSTON, MA) – March 1, 2018 – CARB-X is funding Macrolide Pharmaceuticals of Watertown, MA, to support the development of a novel fully synthetic, orally available macrolide antibiotic with Gram-negative activity, with the aim of treating serious infections including drug-resistant complicated urinary tract infections (cUTI). Under the funding agreement, CARB-X will award Macrolide an initial award of up to $2.44 million, with the possibility of $4.37 million more if certain project milestones are met.

“Macrolide’s program to develop macrolide antibiotics active against Gram-negative bacteria brings exciting new science to the CARB-X portfolio. The world urgently needs new antibiotics, rapid diagnostics, vaccines and entirely new approaches to protect us against 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 development, and there is always a risk of failure. But if successful, these innovative projects, like the Macrolide project, hold great potential to treat life-threatening infections and fight against drug-resistant bacteria.”

“We are delighted to be partnering with CARB-X on this program to develop novel macrolides with first-in-class activity against drug-resistant Gram-negative pathogens,” said Richard Alm, PhD, Vice President of Biology and the collaboration’s Principal Investigator. “Rapidly increasing resistance in these organisms have reduced the effectiveness of many current antibiotic classes and created significant unmet clinical need. This award from CARB-X supports our efforts to leverage our powerful synthetic chemistry platform to develop novel therapeutics for patients with complicated urinary tract infections and will rapidly advance our lead candidates towards clinical trials.”

As an antibiotic class, macrolides are known to be effective against many Gram-positive pathogens, however, to date scientists have been unable to achieve macrolide activity against drug-resistant Gram-negative pathogens. Macrolide is leveraging its proprietary chemistry platform to re-engineer the macrolide scaffold with the aim of developing a new fully-synthetic macrolide antibiotic to treat drug-resistant cUTI infections that can be administered intravenously and orally. The company’s novel macrolides will also avoid macrolide-resistance mechanisms. The CARB-X funding will accelerate the company’s cUTI early development program to reach human clinical studies.

Urinary tract infections can affect several parts of the urinary tract including the kidneys and are among the most common type of infections in healthcare settings. The leading bacterial causes of cUTIs such as Escherichia coli are increasingly becoming drug-resistant and difficult to treat.

CARB-X portfolio focused on most serious Superbugs

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 24 projects in all including therapeutics, vaccines and diagnostics to respond to the threat of drug-resistant bacteria. CARB-X, which stands for Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, currently funds projects in 6 countries and is working to expand its pipeline with the best science from around the world.

Since the beginning of 2017, including the Macrolide project, CARB-X has announced awards projects totaling $64.64 million, plus an additional $81.42 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 on further funding announcements later this year.

New antibiotics, diagnostics and other products are needed urgently to treat bacteria that are increasingly becoming resistant to existing antibiotics. According to the World Health Organization (WHO), an estimated 700,000 people die each year around the world from bacterial infections. In the US alone, an estimated 23,000 people die each year from drug-resistant bacterial infections, according to the Centers for Disease Control and Prevention (CDC).

Partnership to drive antibacterial innovation

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, and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

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 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 new antibacterial products with novel mechanism of action that will be beneficial to treat patients with life-threatening infections and enhance national security and global health security. At BARDA, we are committed to innovation and revitalizing the antibacterial pipeline of drug candidates with novel mechanisms of action compared to currently available drugs through a combination of incentives. Today we add another product to the Powered by CARB-X portfolio, furthering 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’s 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 US Centers for Disease Control and Prevention (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

Macrolide Pharmaceuticals: Barry Wohl
bwohl@macrolide.com

About CARB-X

CARB-X is the world’s largest public-private partnership devoted solely to accelerating 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 antibiotics and other 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 Macrolide Pharmaceuticals

Macrolide Pharmaceuticals is a next-generation antibiotics company developing macrolides that are first-in-class with Gram-negative activity and have broad applicability across infectious diseases and beyond. The company was founded in 2015 with a fully-synthetic technology platform licensed from Harvard University. The platform is a groundbreaking technological advance that holds the foundational key to discover and create new macrolides from basic chemical building blocks that transform this class from its traditional Gram-positive spectrum to include multi-drug resistant (MDR) Gram-negative pathogens. Macrolide is supported and advised by world-class investors, partners, Board members, scientific advisors and funding organizations. Its lead program aims to address MDR infections caused by Gram-negative pathogens.

Macrolide is headquartered in Watertown, Massachusetts. For more information, please visit the Macrolide website at www.macrolide.com.

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.