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Announces Positive Top Line Results from a Phase 1 Study with PUR3100, a Novel Orally Inhaled Dihydroergotamine (DHE), for Acute Migraine
was safe and all doses had fewer GI side effects compared to IV DHE
demonstrated a five-minute Tmax and Cmax within the targeted therapeutic range for all three doses tested
Mass., January 4, 2023 - Pulmatrix, Inc. (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled
therapies to address serious disease using its patented iSPERSE technology, today announced successful completion of a Phase 1
trial evaluating safety and pharmacokinetics of PUR3100 in healthy volunteers. PUR3100 uses the Company's iSPERSETM
formulation technology to create an orally inhaled dry powder formulation of dihydroergotamine (DHE) for the treatment of acute migraine.
Phase 1 trial, performed at Nucleus Network in Melbourne, Australia, was a double-dummy, double-blinded design to assesses the safety,
tolerability, and pharmacokinetics (PK) of three 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.
was well-tolerated and there was a lower incidence of nausea in PUR3100 dose groups compared to IV DHE. No emesis was observed in any
of the PUR3100 dose groups. Oral inhalation of PUR3100 achieved peak exposures in the targeted therapeutic range at all doses and the
Tmax occurred at 5 minutes after dosing. Pulmatrix plans to present the data at an appropriate upcoming scientific conference.
Dose selection is underway for the Phase 2 study and an FDA meeting will be requested this month.
Margaret Wasilewski, Chief Medical Officer of Pulmatrix, commented, "PUR3100 demonstrated a Cmax in the target range
for systemic exposure at all doses and higher than the published Cmax data for all other non-IV DHE products. The five-minute
Tmax achieved is earlier than published Tmax data for all non-IV DHE products." Dr. Wasilewski continued,
"We are excited to see how this pharmacokinetic differentiation potentially translates into clinical efficacy in the Ph2 proof-of-concept
study that we intend to review with the FDA in the first half of 2023."
Raad, Chief Executive Officer of Pulmatrix, noted "We are very excited by the results of this study with inhaled PUR3100. We believe
the PUR3100 formulation of DHE is highly differentiated from other DHE products already approved or in development, can be immediately
self-administered, and has a pharmacokinetic profile that may be ideal for treating patients with acute migraine."
data are very encouraging and suggest that the orally inhaled formulation of dihydroergotamine, PUR3100, will result in rapid systemic
exposure in the therapeutic range, while minimizing the risk of side effects related to exposure levels associated with IV dosing"
commented Dr Stewart Tepper MD, Professor of Neurology at the Geisel School of Medicine of Medicine at Dartmouth, who serves on the Clinical
Advisory Board of Pulmatrix.
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
complete 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.
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 for neurologic disorders such as acute migraine, where rapid systemic exposure could be beneficial. Pulmatrix's product candidates
are based on its proprietary engineered dry powder delivery platform, iSPERSE .
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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