Full Press Release Details
Announces Patient Dosing Completed for its Novel Inhaled Therapy PUR3100 for Acute Migraine
is evaluating its iSPERSETM 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
Mass., September 26, 2022 - 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.
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.
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."
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.
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."
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.
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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