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HT-006 is a new molecular entity (NME) developed by the Walter Reed Army Institute of Research with a novel antibacterial mechanism of action that targets multiple bacterial pathogens.
While HT-006 has the potential to treat many different types of bacterial infections, Hoth will initially target treatment of serious bacterial infections of the lung, such as hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP). Both HAP and VAP are considered life-threatening diseases for which current treatment options are limited or not effective against multi-drug resistance bacteria. As such, Hoth intends to pursue streamlined development opportunities under the U.S. Food and Drug Administration’s (FDA) program for “antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases.” This streamlined program allows for the use of nonclinical animal studies to reduce clinical studies required for approval.
Preclinical studies investigating the minimal inhibitory concentration of HT-006 for various multi-drug resistant bacterial species are planned to start in Q1 2021.
Upcoming Milestones: Completion of proof-of-concept work in Q4 2021