Pulmatrix Announces Positive Results from Phase 1 with PUR3100, an Orally Inhaled Novel Dihydroergotamine DHE (DHE) for Acute Migraine
PUR3100 was safe, and all doses of the drug had fewer GI side affects than IV DHE.
PUR3100 performed a five minute Tmax Cmax Within the therapeutic range of all three doses tested
LEXINGTON, Mass., Jan. 4, 2023 /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 successful completion of a Phase 1 trial evaluating safety and pharmacokinetics of PUR3100 in healthy volunteers. PUR3100 uses iSPERSE technology from the Company.™ A formulation technology was used to make an orally inhaled dry-powder formulation of dihydroergotamine, DHE (for the treatment of acute headaches).
The Phase 1 trial was conducted at Nucleus Network. Melbourne, AustraliaThis double-blinded, double dummy study evaluated the safety, tolerance, and pharmacokinetics in three doses inhaled PUR3100 combined with intravenous (IV), placebo. It was compared to one IV DHE (DHE Mesylate Injection) with inhaled placebo. The study included 26 healthy subjects. Each of the four groups had at least six subjects.
The PUR3100 dosage groups were well tolerated and the incidence of nausea was lower than that experienced with IV DHE. None of the PUR3100 dosage groups experienced emesis. Oral inhalation with PUR3100 reached peak exposures within the target therapeutic range at all doses.max The results occurred 5 minutes after the dosing. Pulmatrix plans on presenting the data at a suitable upcoming scientific conference. For the Phase 2 study, dosage selection is ongoing and an FDA meeting will also be requested.
Dr. Margaret WasilewskiPulmatrix’ Chief Medical Officer, Dr. Judith Sullivan, stated, “PUR3100 demonstrated C.”Maximize In the target range of systemic exposure at all doses, and higher than the C publishedmax All other DHE products that are not IV-compatible. The five-minute Tmax It was achieved earlier than T publishedmax All non-IV DHE products data. Dr. Wasilewski stated, “We are thrilled to see how this potential pharmacokinetic differentiation can translate into clinical efficacy for the Ph2 evidence-of-concept trial that we intend to review in the first half 2023 with FDA.”
Ted RaadPulmatrix’s Chief Executive Officer, said, “We are extremely excited about the results of this research with inhaled Pul3100. 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.”
Dr. Stewart Tepper MD, Professor of neurology at the Geisel Medical School of Medicine Dartmouth, who sits on the Clinical Advisory Board of Pulmatrix.
Information about Migraine
According to the Migraine Research Foundation (MRF), 38 million Americans suffer migraine attacks. These migraines are typically one to two per month. Migraines are responsible for approximately 1.2 million annual emergency room visits. 75 percent of migraine sufferers cannot get relief from their current medications, which indicates the need for new treatments. The current options for dihydroergotamine administration are limited to intravenous. This usually means that patients will need to be administered in an emergency room or via nasal spray.
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 portfolio includes treatments for severe lung diseases such as allergic bronchopulmonary asthma (“ABPA”) and chronic obstructive pulmonary disease (“COPD”) as well as neurologic disorders like acute migraine where systemic exposure may be beneficial. Pulmatrix’s product candidates are based on its proprietary engineered dry powder delivery platform, iSPERSE™.
About iSPERSE™ Technology
Our innovative particle engineering technology creates dry particles, which overcomes the limitations of traditional inhaled technologies and expands our range of inhalable drug therapies. iSPERSE allows a wide variety of drugs to become small, dense and dispersible particles. This allows drug delivery to be highly efficient and penetrates deeply into the lungs. iSPERSE delivers small molecules, drug mixtures, proteins, and nucleic acid via the respiratory system to treat both respiratory and nonrespiratory disease.
Forward-Looking Statements
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SOURCE Pulmatrix, Inc.