Pulmatrix has announced that a Phase 1 PK trial of its PUR3100 dihydroergotamine (DHE) DPI in healthy volunteers demonstrated that all 3 doses tested produced peak exposures in the desired range with a Tmax of 5 minutes post-dose. Subjects receiving PUR3100 also experienced less nausea than those getting IV DHE. Pulmatrix, which is developing PUR3100 for the treatment of migraine headaches, had announced the initiation of the Phase 1 trial in July 2022.
Pulmatrix Chief Medical Officer Margaret Wasilewski said, “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. We are excited to see how this pharmacokinetic differentiation potentially translates into clinical efficacy in the Phase 2 proof-of-concept study that we intend to review with the FDA in the first half of 2023.”
CEO Ted Raad commented, “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.”
Read the Pulmatrix press release.
