Company is evaluating its iSPERSE™ orally inhaled dry powder formulation of dihydroergotamine (DHE) for treatment of acute migraine and expects pharmacokinetic data from the Phase 1 study in Q4 2022
LEXINGTON, Mass., Sept. 26, 2022 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious disease using its patented iSPERSE™ technology, today announced that all subjects have completed dosing in a Phase 1 trial evaluating PUR3100, a novel orally inhaled formulation of dihydroergotamine (DHE) in healthy volunteers. Phase 1 data from this study is expected in Q4 2022.
The Phase 1 trial has a double-dummy, double-blinded design to assesses the safety, tolerability and pharmacokinetics of three distinct dose groups of inhaled PUR3100 with intravenous (IV) placebo compared to a single dose of IV DHE (DHE mesylate injection) with inhaled placebo. Twenty-six healthy subjects were enrolled and each of the four groups contained at least six subjects.
Ted Raad, Chief Executive Officer of Pulmatrix, noted "We believe that both the convenience and potential efficacy and tolerability profile of an inhaled DHE will allow for significant adoption, particularly among those who cannot obtain relief from current prescription medications. We look forward to advancing PUR3100 to potentially be a best-in-class product for this debilitating disease."
According to the Migraine Research Foundation, thirty-eight million people in the U.S. experience migraine attacks, defined as typically one to two migraines per month. Migraines account for 1.2 million emergency room visits each year. Most people with migraines (75%) cannot obtain relief from current prescription medications indicating a need for new treatments. Dihydroergotamine (DHE) administration options are currently limited to intravenous, generally requiring administration in the emergency department, or nasal spray administration which is not well-tolerated by all patients.
Dr. Margaret Wasilewski, Chief Medical Officer of Pulmatrix, commented, "We are evaluating a proprietary formulation of inhaled PUR3100 for the potential treatment of acute migraine - an underserved neurological disease for which patients are in great need of different therapeutic options. Pulmatrix's iSPERSE technology enables a formulation of DHE that can be immediately self-administered, and thereby, offers the potential for an optimized treatment for acute migraine patients in terms of timing and convenience of administration."
About Pulmatrix, Inc.
Pulmatrix is a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE™ technology. The Company's proprietary product pipeline includes treatments for serious lung diseases, such as allergic bronchopulmonary aspergillosis ("ABPA"), Chronic Obstructive Pulmonary Disease ("COPD"), and neurologic disorders such as acute migraine. Pulmatrix's product candidates are based on its proprietary engineered dry powder delivery platform, iSPERSE™, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.
About iSPERSE™ Technology
Our innovative particle engineering technology creates dry powder, which solves limitations of conventional inhaled technologies and expands the universe of inhalable drug therapies. iSPERSE is a proprietary technology that allows a broad range of drugs to be formulated as small, dense, and dispersible particles for highly efficient drug delivery and deep penetration into the lungs. iSPERSE can efficiently deliver small molecules, drug combinations, peptides, proteins, and nucleic acids via the respiratory system for the treatment of both respiratory and non-respiratory diseases.
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Timothy McCarthy, CFA
SOURCE Pulmatrix, Inc.