Pulmatrix, Inc. announced successful completion of a Phase 1 trial evaluating safety and pharmacokinetics of PUR3100 in healthy volunteers. PUR3100 uses the Company's iSPERSE™ formulation technology to create an orally inhaled dry powder formulation of dihydroergotamine (DHE) for the treatment of acute migraine. The Phase 1 trial, performed at Nucleus Network in Melbourne, Australia, was a double-dummy, double-blinded design to assesses the safety, tolerability, and pharmacokinetics (PK) of three dose groups of inhaled PUR3100 with intravenous (IV) placebo, compared to a single dose of IV DHE (DHE mesylate injection) with inhaled placebo.

Twenty-six healthy subjects were enrolled and each of the four groups contained at least six subjects. PUR3100 was well-tolerated and there was a lower incidence of nausea in PUR3100 dose groups compared to IV DHE. No emesis was observed in any of the PUR3100 dose groups.

Oral inhalation of PUR3100 achieved peak exposures in the targeted therapeutic range at all doses and the Tmax occurred at 5 minutes after dosing. Pulmatrix plans to present the data at an appropriate upcoming scientific conference. Dose selection is underway for the Phase 2 study and an FDA meeting will be requested this month.

According to the Migraine Research Foundation, thirty-eight million people in the U.S. experience migraine attacks, defined as typically one to two migraines per month. Migraines account for 1.2 million emergency room visits each year. Most people with migraines (75%) cannot obtain complete relief from current prescription medications indicating a need for new treatments.

Dihydroergotamine (DHE) administration options are currently limited to intravenous, generally requiring administration in the emergency department, or nasal spray administration which is not well-tolerated by all patients.