MannKind Corporation has announced that a previously announced Phase 1 study of its Treprostinil Technosphere (TreT) DPI in healthy volunteers has met its primary endpoint of safety and tolerability, and the company is now preparing for a study in patients with pulmonary arterial hypertension (PAH).
According to the company, data from the study, which enrolled 48 subjects, showed that the TreT could be delivered in less than 10 seconds in 1 or 2 inhalations and that the maximum tolerated dose should result in higher plasma concentrations than those reported for Tyvaso treprostinil inhalation solution. No serious adverse events were reported.
MannKind Chief Medical Officer David Kendall commented, “We are pleased to have completed the TreT Phase 1 trial, which met the study’s safety, tolerability and pharmacokinetics objectives. We are excited to utilize our existing technology platform and device capabilities to create an easy-to-use and tolerable formulation of treprostinil to help unmet patient needs in a serious chronic disease such as PAH.”
The company said that it plans to make use of the 505(b)(2) regulatory pathway for TreT.
Read the MannKind Corporation press release.
