Pulmatrix has concluded subject dosing in a Phase I clinical trial of the new inhaled therapy, PUR3100, to potentially treat acute migraines.
PUR3100 is a new iSPERSE orally inhaled dry powder formulation of dihydroergotamine (DHE).
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The double-dummy, double-blinded trial will evaluate the safety, tolerability, and pharmacokinetics of three different doses of inhaled PUR3100 plus an intravenous (IV) placebo, versus a single IV dose of DHE mesylate injection plus an inhaled placebo in healthy subjects.
A total of 26 subjects were enrolled in the trial, with four study groups having a minimum of six subjects.
The company anticipates reporting pharmacokinetic findings from the trial in the fourth quarter of this year.
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Pulmatrix chief medical officer Dr Margaret Wasilewski said: “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.
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By GlobalData“Pulmatrix’s iSPERSE technology enables a formulation of DHE that can be immediately self-administered, and thereby offers the potential for an optimised treatment for acute migraine patients in terms of timing and convenience of administration.”
The clinical-stage biopharmaceutical firm focuses on the development of new inhaled treatments for serious pulmonary and non-pulmonary diseases, leveraging its iSPERSE technology.
This particle engineering technology produces dry powder to overcome the constraints of traditional inhaled technologies.
It can effectively offer drug combinations, small molecules, peptides, proteins, and nucleic acids through the respiratory system to treat respiratory, as well as non-respiratory, ailments.
In February 2019, Pulmatrix announced plans to commence a Phase II trial of Pulmazole following approval from the US Food and Drug Administration.
