MannKind Successfully Completes Phase 1 Trial of Treprostinil Technosphere

MannKind (Nasdaq:MNKD) announced that it has completed a Phase 1 clinical study of Treprostinil Technosphere (TreT) under an Investigational New Drug application filed with the Food and Drug Administration.

As quoted in the press release:

“We are pleased to have completed the TreT Phase 1 trial, which met the study’s safety, tolerability and pharmacokinetics objectives,” stated David Kendall, Chief Medical Officer of MannKind. “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.”

TreT is proposed as a drug-device combination product for the treatment of patients with pulmonary arterial hypertension (PAH), utilizing a small, portable, breath-powered inhaler that is intended to simplify drug dosing. The regulatory and development pathway is expected to be capital efficient, using existing safety data of the component API to reduce Phase 3 requirements to a pivotal safety and efficacy trial and a pivotal bioequivalency trial.  The regulatory submission in the United States is expected to utilize the 505(b)(2) pathway.

Click here to read the full press release.