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Pulmatrix Receives FDA Acceptance of IND Application for PUR3100 in the Treatment of Acute Migraine

Wednesday, September 20, 2023

Pulmatrix, Inc. (NASDAQ: PULM), a clinical-stage biopharmaceutical company focused on developing innovative inhaled therapies for serious pulmonary and central nervous system diseases, has announced that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application for PUR3100. Additionally, the company has received a letter allowing the study to proceed for a Phase 2 clinical trial. This trial will be a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and efficacy of PUR3100 (Dihydroergotamine Mesylate Inhalation Powder) in the acute treatment of migraines. PUR3100 utilizes Pulmatrix's proprietary dry powder delivery technology, known as iSPERSE™, to administer Dihydroergotamine (DHE) via oral inhalation using a dry powder inhaler.

Dr. Margaret Wasilewski, Chief Medical Officer of Pulmatrix, expressed satisfaction with the acceptance of the PUR3100 IND and the receipt of clearance for the Phase 2 study. She emphasized the company's anticipation of building upon positive safety and pharmacokinetic data from the Phase 1 trial.

Ted Raad, Chief Executive Officer of Pulmatrix, highlighted the potential differentiating factors of PUR3100 compared to existing acute migraine therapies, including its convenience for self-administration, potential for rapid pain relief, and improved tolerability of DHE. The Phase 1 study demonstrated favorable pharmacokinetics and enhanced tolerability compared to intravenous (IV) DHE. Pulmatrix is actively exploring avenues to advance PUR3100 into a Phase 2 clinical trial to further investigate its efficacy, safety, and tolerability in treating acute migraine patients.

PUR3100 is an orally inhaled formulation of dihydroergotamine (DHE), utilizing iSPERSE™ technology for the treatment of acute migraines. The Phase 1 trial results were presented at the 65th Annual Meeting of the American Headache Society in June 2023. With over 38 million migraine sufferers in the United States, there is currently no orally inhaled DHE treatment option available.

iSPERSE™ is an innovative particle engineering technology that produces dry powder, overcoming limitations of conventional inhaled technologies and expanding the potential for inhalable drug therapies. This proprietary technology allows for the formulation of small, dense, and dispersible particles for highly efficient drug delivery and deep lung penetration. iSPERSE™ enables the delivery of a wide range of substances, including small molecules, drug combinations, peptides, proteins, and nucleic acids through the respiratory system for the treatment of both respiratory and non-respiratory diseases.

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