MicroDose Therapeutx Announces Successful Completion of Phase 1 Pilot Study with Inhaled Atropine as Antidote to Nerve Agents

MicroDose Therapeutx Announces Successful Completion of Phase 1 Pilot Study with Inhaled Atropine as Antidote to Combat Effects of Nerve Agent Poisoning

MONMOUTH JUNCTION, N.J.--(BUSINESS WIRE)--MicroDose Therapeutx Inc. today announced that its collaborators at the University of Pittsburgh (Pitt) have completed 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 MicroDose's development of an atropine inhaler to treat nerve agent poisoning targeted for military and civil defense applications. Results of the study will be presented by Pitt and MicroDose at the 18th Congress of the International Society for Aerosols in Medicine in Rotterdam, June 19-22. The U.S. Department of Defense Chemical Biological Medical Systems Joint Project Management Office manages the contract awarded to Pitt to conduct studies of this potential treatment for the effects, including bronchopulmonary symptoms, of mild to moderate organophosphorus poisoning after adequate amounts of injectable atropine have been administered.

The Phase 1 clinical trial was an open-label, active-controlled, crossover, safety study investigating the pharmacokinetics of atropine dry powder inhalation in 17 adult healthy subjects. The trial compared multiple inhalations of an atropine dry powder with one dose of a commercially marketed atropine intramuscular (IM) injection. The primary endpoint of the trial was pharmacokinetic comparison between inhaled and intramuscular atropine over 12 hours. Pitt researchers conducted the study using 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%, relative to IM atropine) to attain both local and systemic signs of atropinization," 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."

Principal investigator, Tim Corcoran, Ph.D., Assistant Professor of medicine and bioengineering at Pitt, said, "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. The inhaler could provide substantial and consistent systemic dosing rapidly after administration."

Chemical and biological agents pose a considerable threat to the warfighter and potentially to other support personnel and civilians. In developing new antidote delivery systems MicroDose hopes to offer a non-invasive treatment alternative to protect 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 IM injection. The development of an inhaled atropine, a specific antidote for the treatment of poisoning from organophosphorus nerve agents, offers a novel, cfc-free 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.

Additional study details are provided on the clinicaltrials.gov website: http://www.clinicaltrials.gov/ct2/show/NCT00947596?term=NCT00947596&rank=1.

About MicroDose Therapeutx

 MicroDose Therapeutx is a private pharmaceutical company dedicated to improving the quality of life for people suffering from serious diseases. The company focuses on developing proprietary products that address large unmet market opportunities, and on pulmonary and oral drug delivery platforms. The company develops its products and technologies independently, as well as in partnership with leading pharmaceutical companies. MicroDose's current pipeline targets respiratory diseases such as asthma, COPD and respiratory syncytial virus (RSV), as well as IBS-C and constipation. More can be found at our website; www.mdtx.com.

About the MicroDose Dry Powder Inhaler (DPI)

 The MicroDose DPI is among a number of key proprietary drug delivery technologies developed by MicroDose. By employing piezo electronics, the MicroDose DPI has the potential to deliver enhanced performance as compared to other inhalers, offering efficient and reproducible delivery independent of patient coordination, inhalation rate and posture. MicroDose believes that the flexibility of the inhaler makes it a true platform technology, able to support a broad pipeline of products across the spectrum of patient populations and therapeutic categories.