New inhaled formulation of dihydroergotamine (DHE) intended for acute migraine therapy begins clinical development with Phase 1 study
LEXINGTON, Mass., July 12, 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 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.
The 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.
Dr. 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."
Ted 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."
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.
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Timothy McCarthy, CFA
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SOURCE Pulmatrix, Inc.