LONDON – The U.S. and U.K. have joined forces in the formation of a public-private partnership to turbocharge early stage antibiotic research and rejuvenate the product pipeline for the next 25 years.
The partnership, Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (Carb-x), will provide $450 million over the next five years to supply funding, research services and business mentoring for companies developing new antibiotics.
Carb-x addresses the goals of the U.S. national action plan to combat resistant bacteria, and its approach also is in line with the recommendations of the U.K. government’s independent review of antimicrobial resistance (AMR), published in May.
The U.S. Biomedical Advanced Research and Development Authority (BARDA) will put in $30 million in the first year and up to $250 million over five years. On the U.K. side, the recently established AMR center (AMRC) is contributing $14 million in year one and up to $100 million over five years.
The U.K. medical research charity Wellcome Trust will add further funding, but that amount has not been disclosed.
“We need new drugs,” Nicole Lurie, assistant secretary for preparedness and response, U.S. department of health and human services, told a teleconference held to discuss the initiative. Carb-x will boost scientific research and advance discovery and development. It will act as “a watershed movement to tackle a monumental public health threat of our time,” Lurie said.
There is a need for a global effort, according to Carb-x’s executive director and principal investigator, Kevin Outterson, professor of law at Boston University. “Bacteria do not need passports to cross national boundaries,” Outterson said.
The Carb-x partners will pool their broad scientific, technical, business and legal expertise to help grantees navigate the maze of regulatory steps, studies and data collection required for new drugs and other products to gain approval from U.S. and/or European regulators, he noted. In the first year, Carb-x will target superbugs such as those causing resistant gram-negative infections. “We want a new antibody class,” Outterson said.
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), noted NIAID has been increasing its budget for anti-infective research over the past five years.
In 2016, $410 million will be spent on resources such as animal models, isolates, reagents and other tools. The mission of Carb-x “complements and overlaps” with that in spurring preclinical discovery and development of new antibiotics.
NIAID will provide in-kind services, including preclinical services, to projects that Carb-x supports, and will provide technical support for Carb-x from its in-house subject matter experts.
Joe Larsen, acting deputing director of BARDA, told BioWorld Today there will be no limitations on who can apply for Carb-x funds. “The focus is on innovation – the scope and remit is global,” he said.
CREATING AN ECOSYSTEM
Carb-x is applying BARDA’s existing support measures for helping products to market. “We want to remove any barriers to any company wanting to develop an antibiotic,” Larsen said.
Historically, BARDA has helped companies with antibiotic products at phase I to move through to regulatory approval. Seven partnerships currently are developing nine antibiotics, of which five are now in phase III.
“In the next two – three years we should see these matriculate and get to market,” Larsen said. However, further back in the pipeline things are fragile. “We wanted to apply the BARDA model to an earlier stage of development and so create an ecosystem,” Larsen said.
BARDA and NIAID have spent nine months doing research to define where Carb-x should focus, talking to venture capitalists (VCs) and other stakeholders to understand where the gaps lie.
While the preclinical in vitro and in vivo models in antibiotics provide safety and efficacy data that read across well to the clinic, it is difficult to get funding for preclinical work.
“The VCs said if you generate data proving safety and efficacy in vitro and in vivo, products would be de-risked,” said Larsen. That would create an environment where more private capital was attracted to antibiotic development.
There are companies which are known to be interested in accessing Carb-x support and it is intended there will be 20 candidates in the incubator at any one time. Funding will be milestone-based and compounds at any stage up to phase 1 development are eligible. Larsen said the minimum objective is to advance two products to first-in-human studies in the next five years.
While Carb-x may succeed in pushing more products from academic research to being ready for clinical development, Larsen acknowledged that Carb-x will not generate market pull.
Use of antibiotics diminishes their utility. “If you can’t sell the product, you won’t attract pharma in,” said Larsen. A number of possible solutions to de-link profits on anti-infectives from the volume sold are under discussion. “The energy and political will around this are as great as I have ever seen,” Larsen said.
Once Carb-x is officially off the ground, Larsen said there will be an effort to attract more partners. “[Carb-x] is designed so it is modular, so others can join in,” he said. Anyone joining will be allowed a “strategic seat at the table,” he added.
Carb-x will begin reviewing applications in September. Decisions will be made by the its scientific advisory board, with input from the agencies, including BARDA and NIAID, and the funders.