Trying to Change the Tides
Both Leuchtenberger and Rib-X CMO Scott Hopkins, M.D., added that from their perspective, companies are still out there and are more encouraged than in the past. This is partly due to an improving regulatory climate and also because the discovery process is finally bringing forth some interesting compounds.
“The large companies are desperate for compounds,” Leuchtenberger remarked. Rib-X was in late-stage discussions with companies for in-licensing of its early-stage compounds, including companies that don’t have a historical stake in antibiotics, he added. “With some companies deemphasizing antibiotics and others moving in aggressively, what we’re seeing is really a changing of the guard.”
As for the FDA, at World Health Day, FDA commissioner Margaret A. Hamburg, M.D., said, “We need better, more advanced strategies for evaluating the effectiveness of new antimicrobials once they are in development. This includes new clinical trial designs that reflect the need for important and robust scientific answers but are realistic about constraints such as the number of patients, the size and length of studies, and the cost of the trials.”
She further remarked that the agency would continue its efforts to streamline and modernize regulatory pathways “so that we can expeditiously review applications for new antimicrobial drugs, diagnostics, and vaccines when they come before us.”
Given the current funding climate it will definitely take time to work out the details. Scientists close to the antibiotic crisis say the U.S. cannot afford to wait, as workhorse antibiotics become useless in the fight against emerging resistant infectious organisms.
Some companies are indeed not waiting, leveraging innovative methods to combat the super-bugs. Their path to approval may not be simple, but the novel techniques provide some hope that developing antibiotics to fight against drug-resistance bacterial strains has not completely been forgotten. A future article will delve into some of these approaches.