Pulmatrix, Inc. (NASDAQ: PULM), a clinical-stage biopharmaceutical firm specializing in innovative inhaled therapies for serious pulmonary and central nervous system disorders, has announced that the U.S. Food and Drug Administration (FDA) has accepted the investigational new drug (IND) application for PUR3100 and issued a study may proceed letter. This paves the way for a Phase 2, multicenter, randomized, double-blind, placebo-controlled, single-event study to assess the safety, tolerability, and efficacy of PUR3100 (Dihydroergotamine Mesylate Inhalation Powder) in the acute treatment of migraine. PUR3100 employs Pulmatrix's proprietary dry powder delivery technology, iSPERSE™, to deliver DHE via oral inhalation using a dry powder inhaler.

Dr. Margaret Wasilewski, Chief Medical Officer of Pulmatrix, expressed her satisfaction with the acceptance of the PUR3100 IND and the receipt of the study may proceed letter, emphasizing the positive safety and pharmacokinetic data obtained in the Phase 1 study.

Ted Raad, Chief Executive Officer of Pulmatrix, highlighted the potential differentiation of PUR3100 from other approved acute migraine treatments. This differentiation arises from the convenience of self-administration and the potential for rapid pain relief and enhanced DHE tolerability. He also pointed out that the Phase 1 study demonstrated optimal pharmacokinetics and improved tolerability compared to IV DHE. The company is now exploring options to advance PUR3100 into a Phase 2 clinical trial to further investigate its efficacy, safety, and tolerability in treating acute migraine subjects.