MicroDose initiates Phase 1 clinical trial investigating the pharmacokinetics of atropine inhalation

MicroDose Therapeutx Inc. (formerly MicroDose Technologies) today announced that it has initiated a Phase I study at the University of Pittsburgh Medical Center with atropine sulfate delivered from the MicroDose proprietary dry powder inhaler (DPI). The study is a further step in the development program for an atropine inhaler to treat nerve agent poisoning in military and civil defense applications. The program is being congressionally funded and managed through the Chemical Biological Medical Systems Joint Project Management Office to treat the symptoms, including bronchopulmonary, of mild to moderate organophosphorus poisoning after adequate amounts of injectable atropine have been administered.

The Phase 1 clinical trial is an open-label, active-controlled, crossover, safety study investigating the pharmacokinetics of atropine dry powder inhalation in 18 adult healthy subjects. The trial compares multiple inhalations of an atropine dry powder with one dose of a commercially marketed atropine intramuscular injection. The primary endpoint of the trial is the pharmacokinetic comparison between inhaled and intramuscular atropine over 12 hours.

This study represents the third U.S. clinical trial involving the MicroDose DPI to be initiated within the last 14 months. The study is being conducted through a majority-owned subsidiary, MicroDose Defense Products, LLC.

“We are pleased to announce first patient dosing has taken place at the University of Pittsburgh with our advanced dry powder inhaler,” said Robert O. Cook, Ph.D., Senior Director, Product Commercialization Group, at MicroDose. “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.”

Commenting from the University of Pittsburgh, Tim Corcoran, Ph.D., Principal Investigator of the project said, “We’re proud to partner with MicroDose to provide the Army with this technology. It’s rare for us to work on medicines that we hope never get used, but it’s crucial that these tools be available if they are ever needed.” Dr. Corcoran is Assistant Professor of Medicine and Bioengineering, Division of Pulmonary, Allergy, and Critical Care Medicine and an expert on inhaled medications and aerosols.

Chemical and biological agents pose a considerable threat to the warfighter and potentially to other military personnel and civilians. The development of new antidote delivery systems is a crucial step in protecting personnel from these threats. Dry powder drug delivery through inhalation provides a means of delivering drugs to the site of entry for aerosol agents but also offers access to the bloodstream that rivals the speed of injection. The development of an inhaled atropine, a specific antidote for the treatment of poisoning from organophosphorus nerve agents, offers a new means for defending against the ominous threat of chemical weapons. If successfully clinically tested and approved, the MicroDose system is expected to allow more efficient administration of atropine than is available with existing drug-delivery technologies.