Pulmatrix Says Formulated Inhaled Migraine Candidate Safe With Fewer GI Side Effects Compared To IV

Pulmatrix Inc PULM completed the Phase 1 trial evaluating the safety and pharmacokinetics of PUR3100 in healthy volunteers.
PUR3100 uses the company's iSPERSE formulation technology to create an orally inhaled dry powder dihydroergotamine (DHE) formulation for acute migraine.
Twenty-six healthy subjects were enrolled, and each of the four groups contained at least six subjects.
Related: Pulmatrix's COPD Candidate Shows Early Safety, Preliminary Pharmacokinetic Results.
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.
The company plans to review the Phase 2 proof-of-concept study with the FDA in the first half of 2023.
Price Action: PULM shares are down 14.32% at $3.65 on the last check Wednesday.