Full Press Release Details
Announces First Subject Dosed in Phase 1 Study of PUR3100 for Acute Migraine
inhaled formulation of dihydroergotamine (DHE) intended for acute migraine therapy begins clinical development with Phase 1 study
Mass., July 12, 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 the dosing of the first five
subjects in a Phase 1 trial evaluating PUR3100, a novel pulmonary inhaled formulation of dihydroergotamine (DHE). PUR3100 is formulated
using Pulmatrix's iSPERSE drug delivery technology and is being developed for the treatment of acute migraine.
Phase 1 study design is a double-dummy, double-blinded trial to assess the safety, tolerability, and pharmacokinetics of 3 doses of single
doses of inhaled PUR3100 with IV placebo, as compared to IV DHE (DHE mesylate injection) with inhaled placebo. Twenty-four healthy volunteers
are to be randomized to one of the four dose groups consisting of six subjects each.
Margaret Wasilewski, Chief Medical Officer of Pulmatrix, commented, "Current use of DHE for treatment of acute migraine is limited.
While DHE is a highly efficacious compound, it requires either intravenous administration or nasal delivery which some patients do not
prefer. Common side effects of IV DHE include nausea and vomiting. PUR3100 is an orally-inhaled DHE acute migraine therapy. The Phase
1 study has started and we anticipate safety, tolerability, and pharmacokinetic data in Q4 2022. Study results will guide dose selection
for subsequent registration enabling efficacy studies."
Raad, Chief Executive Officer, noted "We believe that the convenience of a pulmonary DHE will allow for greater adoption, while
optimizing the onset of action and the therapeutic window to potentially be a best-in-class product for this debilitating disease."
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.
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