Pulmatrix seeks US FDA approval to to Initiate phase 2 trial of investigational drug PUR3100 to treat acute migraine

Pulmatrix, Inc., a clinical-stage biopharmaceutical company, announced the submission of an investigational new drug (IND) application to the United States Food and Drug Administration (FDA) for PUR3100, an orally inhaled dry powder formulation of dihydroergotamine (DHE), under development to treat acute migraine. The PUR3100 formulation uses Pulmatrix's novel, proprietary dry powder delivery technology, iSPERSE to deliver DHE directly into the lungs using a dry-powder inhaler. Pulmatrix's IND includes a phase 2 clinical protocol where safety and preliminary efficacy of PUR3100 will be investigated in patients with acute migraine. The phase 1 study data were presented at the American Headache Society 65th Annual Meeting in June 2023. Results showed that the pharmacokinetics (PK) of PUR3100 were similar to the PK of intravenous (IV) DHE with fewer side effects. Dr. Margaret Wasilewski, chief medical officer of Pulmatrix, commented. "In the US there are approximately 40 million patients with acute migraine needing additional therapeutic options. We are excited to see how this pharmacokinetic differentiation potentially translates into clinical efficacy and safety in the proposed phase 2 proof-of-concept study. Based on study results seen to date, we believe that PUR3100 using Pulmatrix's iSPERSE technology could offer a DHE therapy with maximized efficacy, while also providing the convenience of self-administration and reduced systemic side effects." PUR3100 is an orally inhaled DHE engineered with iSPERSE for the treatment of acute migraine. Pulmatrix presented results from the PUR3100 Phase 1 trial at the 65th Annual Meeting of the American Headache society in June 2023. The phase 1 trial was a randomized, double-dummy, double-blinded design to assesses the safety, tolerability, and PK of three dose groups of inhaled PUR3100 with IV placebo, compared to a single dose of IV DHE (DHE mesylate injection) with inhaled placebo. PUR3100 was generally well tolerated with fewer study drug related treatment-emergent adverse events compared to the IV DHE-treated group. The PK for PUR3100 showed a Tmax was at the first time point (5 min) for all PUR3100 doses. All three doses achieved 'therapeutic' exposure levels (>1000 pg/mL). Cmax was within the desired exposure window, with similar Tmax and dose normalized AUC relative to IV DHE. Pulmatrix is a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary diseases and central nervous system (CNS) disorders using its patented iSPERSE technology.

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