New class of LpxC inhibitors earns Forge its second CARB-X award

(BOSTON, MA) – January 03, 2019 – CARB-X is awarding Forge Therapeutics of San Diego, CA, USA, up to $5.7 million in non-dilutive funding, with the possibility of up to $5.4 million more if certain project milestones are met, to develop a novel antibiotic to treat serious lung infections caused by Gram-negative bacteria including multi-drug resistant Pseudomonas aeruginosa. This is Forge’s second project to earn CARB-X support.

“The world urgently needs new classes of antibiotics, like those that Forge is developing, as well as other life-saving products to prevent, diagnose and treat deadly infections,” said Kevin Outterson, Executive Director of CARB-X and Boston University law professor. “Forge’s LpxC-inhibitor project represents an exciting new approach to treating life-threatening infections caused by drug-resistant bacteria. The projects in the Powered byCARB-X portfolio are in the early stages of development, but if successful, they offer tremendous potential in the global fight against superbugs.”

“We are gratified to receive this opportunity to expand our collaboration with CARB-X. This second award allows us to evaluate an entirely new class of LpxC inhibitors against drug-resistant superbug infections present in the lung,” said Zachary A. Zimmerman, Ph.D., CEO of Forge. “We look forward to advancing our portfolio of novel antibiotics with continued CARB-X support.”

LpxC is a validated target in Gram-negative bacteria, but there are no approved therapeutics targeting LpxC. No company has yet succeeded in developing effective compounds, despite multiple efforts. Forge, using its proprietary chemistry platform, has developed novel non-hydroxamate LpxC inhibitors that are safe and effective in an animal model of Gram-negativeinfection,able to kill Gram-negative superbugs where other antibiotics fail.

P. aeruginosais one of the world’s deadliest superbugs, and a common Gram-negative pathogen associated with hospital-acquired infections. Patients on breathing machines, or suffering from cystic fibrosis, surgical wounds or burns are particularly susceptible.The last new class of approved antibiotics for the treatment of Gram-negative bacteria was discovered in 1962.

CARB-X support for the Forge project is possible thanks to funding from the Wellcome Trust, a global charity based in the UK working to improve health globally, 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).

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, 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 CDC. In Europe, the number of deaths each year is estimated at 33,000.

CARB-X’s expanding portfolio

This is CARB-X’s first award of 2019. The Forge project brings to 11 the number of the new classes of antibiotics in the CARB-X portfolio. CARB-X is supporting more than 30 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 $98 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.

Partnership to drive antibacterial innovation globally

CARB-X is a Boston University global partnership funded by BARDA, the Wellcome Trust, the UK Department of Health and Social Care’sGlobal 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 aiming to invest up to $500+ million from 2016-2021 in antibacterial R&D. 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 Office of the Assistant Secretary for Preparedness and Response, Wellcome Trust, or other CARB-X funders.

Media Contacts:

CARB-X:

Jennifer Robinson carbxpr@bu.edu

+1.514.914.8974

Forge Company Contact:

Info@ForgeTherapeutics.com

Forge Media Contact:

Amy Conrad amy@juniper-point.com

+1.858.366.3243

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 is funded by 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), the Wellcome Trust, a global charity based in the UK working to improve health globally, the UK Department of Health and Social Care’sGlobal 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 aims to invest 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 Forge Therapeutics

At Forge Therapeutics, we are developing medicines targeting metal-dependent enzymes found in nature. Over 30% of known enzymes are metalloenzymes, covering all major enzyme classes: oxidoreductases, transferases, hydrolases, lyases, isomerases, and ligases. Metal ions, including magnesium, zinc, iron, manganese and copper are the essential ingredient in these metalloenzymes. At Forge, we are the BLACKSMITHS of modern medicine, providing the tools to address any metalloenzyme challenge.

Forge’s lead effort is focused on LpxC, a zinc metalloenzyme found only in Gram-negative bacteria, which is essential for bacteria to grow. Forge has a strategic drug discovery alliance with Evotec AG and has been awarded funding by CARB-X as well as government agencies. In addition, Forge has amassed a rich intellectual property estate on metalloenzyme-targeted inhibitors to protect its BLACKSMITH platform and pipeline including technology licensed from UCSD. For further information, please visit the company’s websitewww.ForgeTherapeutics.comand follow us on Twitter @ForgeThera.

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.