MicroDose Therapeutx finishes Phase I study of inhaled atropine

MicroDose Therapeutx announced on Tuesday that its collaborators at the University of Pittsburgh Medical Center have completed a Phase I study into an inhaled nerve agent poisoning antidote.

The study tested atropine sulfate delivered from the Microdose proprietary dry powder inhaler to treat nerve agent poisoning to be used for military and civil defense purposes. The study will be presented by MicroDose and Pitt at the 18th Congress of the International Society for Aerosols in Medicine in Rotterdam, the Netherlands, from June 19-22.

“It is a unique application of an aerosolized medication in that it provides both treatment of the lungs locally, as well as a means of delivering drug systemically to the bloodstream,” Tim Corcoran, an assistant professor of medicine and bioengineering at Pitt, said. “The inhaler could provide substantial and consistent systemic dosing rapidly after administration.”

The Phase 1, open-label, active-controlled, crossover, safety study investigated the pharmacokinetics of atropine dry powder inhalation in 17 healthy adult subjects. The endpoint was a pharmacokinetic comparison between inhaled and intramuscular atropine over 12 hours. The study used a device manufactured by subcontractor MicroDose Defense Products, LLC, a majority-owned subsidiary of MicroDose Therapeutx, Inc.

“Follow-up trials will further demonstrate our ability to achieve very high atropine bioavailability from the MicroDose inhaler (85 percent, relative to IM atropine) to attain both local and systemic signs of atropinization,” Robert O. Cook, the senior director of the Product Commercialization Group at MicroDose, said. “While intramuscular injection of atropine is a recognized treatment for acute poisoning, the inhaled route offers a non-invasive alternative by delivering atropine directly to the lungs where local complications present, which may be more convenient when repeated dosings are required.”

An inhaled atropine would potentially offer a novel, cfc-free method for treatment against the threat of chemical weapons. The contract for the project was given to Pitt by the U.S. Department of Defense Chemical Biological Medical Systems Joint Project Management Office.

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U.S. Department of Defense 2 N Rotary Rd Arlington, VA 22202

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