Pulmatrix to present Phase 1 data of PUR3100 in acute migraine

Pulmatrix will present data at the American Headache Society 65th Annual Meeting showcasing data from the Phase 1 study of PUR3100, an orally inhaled dihydroergotamine engineered with iSPERSE for the treatment of acute migraine in 26 subjects, ages 18-49 years. The Phase 1 trial was to assesses the safety, tolerability, and pharmacokinetics of three dose groups of inhaled PUR3100 with intravenous placebo, compared to a single dose of IV DHE with inhaled placebo. PUR3100 was generally well tolerated with fewer TEAEs in PUR3100-treated groups than in the IV DHE-treated group. All three doses achieved ‘therapeutic’ exposure levels. Cmax was within the desired exposure window, with similar Tmax and dose normalized AUC relative to IV DHE. Based on these Phase 1 results, the company plans to advance PUR3100 into Phase 2 testing and plan to file an Investigational New Drug Application with the FDA in mid-2023.