Novo Nordisk Foundation in US$25m partnership with CARB-X

The Novo Nordisk Foundation is committing up to US$25m to support the early-stage development of drugs, vaccines and diagnostics to prevent, diagnose and treat the top priority drug-resistant bacterial pathogen from the CDC and WHO list of infectious threats. The Danish Foundation is granting up to US$25m to Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) over three years. The Foundation joins four G7 government departments or agencies, the British Wellcome Trust and the Bill & Melinda Gates Foundation in supporting CARB-X.

According to estimates, drug-resistant bacterial infections caused 3,500 deaths every day in 2019. As most phama companies have given priority to the development of more lucrative therapeutic areas than the development of new antiinfectives that help prevent infections, diagnose them quickly and accurately, and treat them effectively, the early development space tend to be academic spin-outs and small companies in need of grants and guidance.

CARB-X aims to support these product developers. The partnership, therefore, plays a crucial role in moving promising ideas for cutting-edge antibacterial products from basic research to clinical development and through Phase I trials. Since 2016, CARB-X has funded 93 projects in 12 countries. Nineteen projects have advanced into or completed clinical trials; 12 remain active in clinical development, including late-stage clinical trials; and two diagnostic products have reached the market.

“Like CARB-X, the Novo Nordisk Foundation is committed to driving innovation in the fight against drug-resistant infections,” says Peter Lawætz Andersen, Senior Vice President in Infectious Disease at the Foundation. “By partnering, we can help ensure that the best research gets translated into effective, scalable and affordable medical interventions that can help end this growing pandemic.”

According to the World Health Organization, “the clinical pipeline and the recently approved antibacterial agents are insufficient to tackle the challenge of increasing emergence and the spread of AMR.” Private investments in innovative antibiotics are poor partly because doctors use them only when older and cheaper drugs fail. This is important to prolong their effectiveness, but it also limits their sales.

Due to the strategic stepback of pharma companies from the risky early development of new antibotics, there is a huge funding gap in antibacterial product development. According to estimates of the European Commission, between US$250m and US$400m must be invested annually by public and philanthropic sources to fill the development gap.

Novo Holdings established the REPAIR (Replenishing and Enabling the Pipeline for Anti-Infective Resistance) Impact Fund in 2018 to address this early-stage funding gap. While continuing to support the existing portfolio, REPAIR has paused new investments due to the challenging market conditions, with the Foundation now supporting the critical early-stage pipeline via the philanthropic grant to CARB-X. The organisations are engaged in a range of activities from early development to advocating for payment models that can help rejuvenate the market for antimicrobials.

The Foundation is also funding a major new initiative – the Novo Nordisk Foundation Initiative for Vaccines and Immunity – that will reduce the use of antibiotics and thus the spread of AMR by developing vaccines against respiratory infections. CARB-X provides grantees with scientific, clinical, regulatory, and business development guidance and access to tools that aim to accelerate product development.