Pulmatrix Publishes Clinical Results for Inhaled DHE for Acute Migraine

Pulmatrix, Inc., a clinical-stage biopharmaceutical firm based in Bedford, Massachusetts, has announced promising results from a recent Phase 1 study evaluating PUR3100, an orally inhaled formulation of dihydroergotamine (DHE) designed for the treatment of acute migraine. The study findings were published in the peer-reviewed journal Headache: The Journal of Head and Face Pain.

The Phase 1 trial was a randomized, double-blind study that assessed the safety, tolerability, and pharmacokinetics (PK) of PUR3100 in comparison to intravenously (IV) administered DHE in healthy adults. The study employed a double-dummy design, meaning participants received either inhaled PUR3100 with an IV placebo or IV DHE with an inhaled placebo. The trial included three different dose levels of PUR3100.

Key findings from the study indicate that PUR3100 demonstrated a favorable safety and tolerability profile compared to IV DHE. Participants taking PUR3100 experienced significantly lower incidences of nausea (21% vs. 86%), vomiting (0% vs. 29%), and headache (16% vs. 57%) than those receiving IV DHE.

Pharmacokinetic analysis revealed that PUR3100 achieved a comparable mean time to maximum concentration (Tmax) of 5 minutes, similar to the 5.5 minutes observed with IV DHE. However, PUR3100 exhibited a lower maximum concentration (Cmax) and a reduced area under the curve (AUC0–2h), indicating lower overall drug exposure. Despite this, all doses of PUR3100 successfully reached a mean Cmax above the therapeutic threshold required for efficacy.

Ted Raad, Chief Executive Officer of Pulmatrix, highlighted the potential benefits of PUR3100, stating that the rapid onset of action and enhanced tolerability could significantly improve acute migraine management. Given the positive Phase 1 results, Pulmatrix is now exploring various options to advance PUR3100 into a Phase 2 clinical trial.

Pulmatrix previously received the FDA's acceptance of an Investigational New Drug (IND) application, along with a "study may proceed" letter, marking PUR3100 as ready for Phase 2 development. The company is actively seeking financing or partnership opportunities to support the upcoming trial.

PUR3100 employs Pulmatrix's patented iSPERSE™ technology, which allows the creation of dry powder formulations that can deliver drugs efficiently through inhalation. This technology enhances drug delivery to the lungs, making it possible to treat both respiratory and non-respiratory conditions more effectively.

The publication of these Phase 1 results and the subsequent plans for Phase 2 trials underscore Pulmatrix's commitment to developing innovative therapies for conditions with significant unmet medical needs, such as acute migraine. The company's broader pipeline includes treatments for central nervous system disorders and severe lung diseases, leveraging the iSPERSE™ technology to improve patient outcomes.

Pulmatrix aims to address the therapeutic gaps in migraine treatment, especially given that over 38 million Americans suffer from this debilitating condition, with limited effective inhaled treatment options currently available. The company continues to focus on its mission to create novel inhaled therapeutics that offer better safety, tolerability, and therapeutic efficacy.