Pulmatrix Commences Initial-Stage Acute Migraine Study

Pulmatrix PULM has dosed first subject in its Phase 1 trial evaluating PUR3100 for the treatment of acute migraine.

PUR3100 is an orally-inhaled Dihydroergotamine (DHE) acute migraine therapy.

The Phase 1 clinical study is designed to investigate safety, tolerability, and pharmacokinetics of 3 doses of single doses of inhaled PUR3100 with IV placebo, as compared to IV DHE (DHE mesylate injection) with inhaled placebo. 

The company is planning to enrol 24 healthy volunteers in the study, one of the four dose groups consisting of six subjects each.

Ted Raad, Chief Executive Officer, commented : "We believe that the convenience of a pulmonary DHE will allow for greater adoption, while optimizing the onset of action and the therapeutic window to potentially be a best-in-class product for this debilitating disease."

Dr. Margaret Wasilewski, Chief Medical Officer, stated, "Current use of DHE for treatment of acute migraine is limited.  While DHE is a highly efficacious compound, it requires either intravenous administration or nasal delivery which some patients do not prefer. Common side effects of IV DHE include nausea and vomiting.  PUR3100 is an orally-inhaled DHE acute migraine therapy. The study results will guide dose selection for subsequent registration enabling efficacy studies." 

The data readout from the Phase 1 clinical study is anticipated in Q4 2022.

Price Action : Pulmatrix shares are trading down at $4.63 On Tuesday at the time of publication.