Pulmatrix Announces Peer-Reviewed Publication of Clinical Results for its Orally Inhaled DHE for Acute Migraine (PUR3100)

Core Insights - Pulmatrix, Inc. has developed PUR3100, an orally inhaled formulation of dihydroergotamine (DHE), which shows potential for rapid pain relief and improved tolerability compared to intravenous DHE [2][3] - The Phase 1 study results indicate that PUR3100 has a Tmax of 5 minutes and a Cmax within the therapeutic window, suggesting its efficacy for acute migraine treatment [3] - The company is seeking financing or partnerships to advance PUR3100 into a Phase 2 clinical study [4] Company Overview - Pulmatrix is a clinical-stage biopharmaceutical company focused on innovative inhaled therapies for serious central nervous system and pulmonary diseases using its patented iSPERSE™ technology [2][9] - The company aims to address significant unmet medical needs, particularly in the treatment of acute migraine and other CNS disorders [9] Product Details - PUR3100 is engineered with iSPERSE™ technology, which allows for efficient drug delivery and deep lung penetration, addressing limitations of conventional inhaled therapies [5][6] - The Phase 1 trial demonstrated that all doses of PUR3100 were well tolerated, with significantly lower incidences of nausea (21% vs. 86%), vomiting (0% vs. 29%), and headache (16% vs. 57%) compared to IV DHE [3] Clinical Study Insights - The Phase 1 study was a randomized, double-blind trial comparing inhaled PUR3100 with IV DHE, showing optimal pharmacokinetics and improved tolerability [3] - The pharmacokinetic profile of PUR3100 included a reduced AUC0–2h (1120–4320 vs. 6340) and a lower Cmax (3620–14,400 vs. 45,000), while maintaining efficacy levels above 1000 pg/mL [3] Market Context - Over 38 million patients in the United States suffer from migraines, and currently, there is no orally inhaled DHE treatment option available [5]