Lexington, Massachusetts-based Pulmatrix is evaluating PUR3100 in a Phase 1 trial using the patented iSperse technology. All subjects completed dosing of the novel orally inhaled formulation of dihydroergotamine (DHE). The company expects Phase 1 data in the fourth quarter of this year.
The trial features a double-dummy, double-blinded design. It assesses the safety, tolerability and pharmacokinetics of three dose groups of inhaled PUR3100 with intravenous (IV) placebo.
Pulmatrix is comparing its treatment to a single dose of IV DHE (DHE mesylate injection) with inhaled placebo. The evaluation includes 26 healthy subjects with at least six subjects in each of the four groups.
The company aims to address the limited options of administration for DHE. Currently, according to a news release, it requires intravenous administration in the emergency department or poorly tolerated nasal spray adminsitration.
Combining convenience with efficacy and tolerability
“We believe that both the convenience and potential efficacy and tolerability profile of an inhaled DHE will allow for significant adoption, particularly among those who cannot obtain relief from current prescription medications,” said Pulmatrix CEO Ted Raad. “We look forward to advancing PUR3100 to potentially be a best-in-class product for this debilitating disease.”
Pulmatrix designed iSperse to improve therapeutic delivery to the lungs. It maximizes local concentrations and reduces systemic side effects to improve patient outcomes.
“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,” added Dr. Margaret Wasilewski, Pulmatrix CMO. “Pulmatrix’s iSperse technology enables a formulation of DHE that can be immediately self-administered, and thereby, offers the potential for an optimized treatment for acute migraine patients in terms of timing and convenience of administration.”
