A consortium of more than 30 European companies and universities will work to develop new antibiotics against gram-negative pathogens, through a six-year program to be funded with €85 million ($115.3 million) from the Innovative Medicines Initiative (IMI).
The program, called European Gram Negative Antibacterial Engine (ENABLE), will bring together 32 partners in 13 countries, led by GlaxoSmithKline (GSK) and Sweden’s Uppsala University. The partners will team up to establish a significant antibacterial drug discovery platform for the progression of research programs through discovery and Phase I clinical trials.
Through open calls outside the consortium, ENABLE aims to expand a preliminary portfolio of programs into a full development pipeline. ENABLE’s ultimate goal is to deliver at least one new antibacterial candidate against gram-negative infections into Phase I clinical trials by 2019.
ENABLE is part of the IMI’s New Drugs for Bad Bugs (ND4BB), a series of projects designed to surmount hurdles in the development and effective use of novel antibiotics. The IMI is a partnership of the European Commission and major pharmaceutical companies, acting through their industry group European Federation of Pharmaceutical Industries and Associations (EFPIA).
ENABLE is Europe’s response to the growing challenge of increasing resistance to present-day antibiotics by “superbugs,” a development that has united industry and public health groups on both sides of the Atlantic. In 2012, the United States enacted the wide-ranging FDA Safety and Innovation Act (FDASIA) with incentives designed to stoke commercial development of new antibiotics—most notably the qualified infectious disease product (QIDP) designation for antibiotic drug candidates, which entitles their developers to faster FDA reviews and five additional years of market exclusivity.
One of ENABLE’s partners, Spain’s Fundación MEDINA, will contribute to the consortium one of the new antibiotic molecules to be developed. “Our participation in this program represents a fantastic opportunity to jointly develop one of our most advanced compounds in our pipeline,” Olga Genilloud, MEDINA’s scientific director, said in a statement.
MEDINA works to discover new molecules from its proprietary natural product libraries that have the potential to be developed into new treatments for infectious diseases and other unmet medical needs.
MEDINA is an independent nonprofit R&D organization established jointly by the Spanish autonomous regional government of Andalucía, Spain’s University of Granada, and MSD—the name by which Merck & Co. does business outside the United States and Canada.
Infectious diseases is among areas of focus for Merck. As of January 29, according to ClinicalTrials.gov, the company is recruiting patients for two Phase III trials for its Actoxumab/bezlotoxumab (MK-3415A), a combination of therapeutic antibodies targeting two C. difficile pathogenic toxins (A and B) being evaluated for the prevention of recurrence of C. difficile infection. Merck is developing Actoxumab/bezlotoxumab under an exclusive license with Massachusetts Biological Laboratories and Medarex, a subsidiary of Bristol-Myers Squibb.