MannKind Starting Enrollment of Phase 1 Trial Testing Powdered Treprostinil for PAH

MannKind Corporation will start enrollment for a Phase 1 trial to test its treprostinil inhaled therapy for the treatment of pulmonary arterial hypertension (PAH).

The trial will be conducted under an Investigational New Drug (IND) application filed with the U.S. Food and Drug Administration (FDA).

The company’s Treprostinil Technosphere (TreT) combines the active ingredient treprostinil in a dry powdered formulation that is inhaled via a novel delivery system.

According to the company, the Technosphere formulation is simple to administer and rapidly absorbed, with no liver toxicity, and improved bioavailability (the degree and rate at which a treatment enters circulation).

The dry powder formulation consists of a powder with particles the proper size for delivery to the deep lung. Due to its low density, the powder readily disperses, delivering the medicine directly into circulation and bypassing the liver.

It is designed to be administered through MannKind’s breath-powered inhalation devices, which are small, easy-to-use inhalers that require only the patient’s breath to deliver the right powder dose.

MannKind already commercialized its Technosphere formulation as Afrezza, an inhaled medicine that provides rapid-acting, mealtime insulin to diabetic patients. So far, this is MannKind’s only product approved by the FDA.

Treprostinil has been FDA-approved for PAH treatment since 2002. It can be found in United Therapeutic’s Remodulin, which is administered intravenously or subcutaneously; Tyvaso, an inhalant; and Orenitram, which are oral pills.

MannKind will test TreT in a Phase 1 clinical trial to test its safety, tolerability, and bioavailability in healthy volunteers after administration by oral inhalation. The trial will also evaluate patients’ exposure to the medicine and dosing.

“We are excited to initiate enrollment of our Phase 1 clinical study and to extend the potential application of the Technosphere platform for unmet patient needs in a serious chronic disease such as PAH,” David Kendall, MD, chief medical officer of MannKind, said in a press release.

“We believe this study will allow for rapid evaluation of treprostinil dosing and therapeutic use in pulmonary arterial hypertension. If successful, this Phase 1 study will lead to registration studies in 2019,” he said.