Pulmatrix said that the first subjects have been dosed in a Phase 1 trial of the company’s PUR3100 dry powder dihydroergotamine (DHE), which is based on Pulmatrix’s iSPERSE particle engineering platform. The company announced in March 2021 that it intended to develop the PUR3100 DPI for the treatment of migraines. The Phase 1 trial is expected to enroll 24 healthy volunteers and will compare 0.5 mg, 1.0 mg, and 1.5 mg doses of inhaled PUR3100 to IV DHE and to placebo.
Pulmatrix Chief Medical Officer Margaret Wasilewski commented, “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 Phase 1 study has started, and we anticipate safety, tolerability, and pharmacokinetic data in Q4 2022. Study results will guide dose selection for subsequent registration enabling efficacy studies.”
CEO Ted Raad said, “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.”
Read the Pulmatrix press release.
