Paratek Pharmaceuticals this week announced a new cooperative research effort with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) to study omadacycline against pathogenic agents causing infectious diseases of public health and biodefense importance.
These studies are designed to confirm dosing regimens and assess efficacy of omadacycline against biodefense pathogens, including Yersinia pestis (plague) and Bacillus anthracis (anthrax).
Omadacycline is the first in a new class of tetracyclines known as aminomethylcyclines, with broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria. The therapeutic has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration.
Funding support for the trial has been made available through the Defense Threat Reduction Agency (DTRA)/Joint Science and Technology Office (JSTO) and Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD)/Joint Project Manager Medical Countermeasure Systems (JPM-MCS)/BioDefense Therapuetics (BDTX).
“Scientists at USAMRIID recognize the unique potential of omadacycline as a novel once-daily oral antimicrobial agent and we are extremely pleased to have the opportunity to work with USAMRIID on these projects,” said Evan Loh, President and Chief Medical Officer, Paratek. “Earlier research suggests the potential efficacy of omadacycline against anthrax, plague, and other diseases of public health and biodefense concern, which underscores the importance of this partnership and the potential outcomes of these studies. Considering omadacycline’s broad spectrum of activity, oral bioavailability and robust safety and tolerability profile, we believe it is an excellent candidate for study in these infections.”
“We welcome the partnership with Paratek, DTRA-JSTO and JPEO-CBD/JPM-MCS/BDTX to evaluate a new therapeutic that may provide unique advantage in the important area of biodefense,” said Colonel Bret Purcell, Ph.D., M.D. (Director of Translational Sciences and Chief, Therapeutics Division, USAMRIID). “This agreement with Paratek seeks to improve our understanding about the potential utility of omadacycline against these pathogens.”
Under the terms of the CRADA, Paratek will provide omadacycline and technical expertise to support USAMRIID’s conduct of the pre-clinical pharmacokinetic studies and efficacy studies of omadacycline against a variety of biodefense pathogens. Data generated from these studies may support further development, which could ultimately lead to the approval of omadacycline in the treatment of these important biodefense pathogens.
