MannKind Corporation has announced the initiation of a Phase 1 clinical study of its dry powder formulation of treprostinil based on its Technosphere inhaled delivery technology for the treatment of pulmonary arterial hypertension (PAH). The company said that the Treprostinil Technosphere (TreT) study is being conducted under an IND filed with the FDA in January.
The Technosphere platform is the same technology used for formulation of MannKind’s inhaled insulin, Afrezza, which was approved by the FDA in 2014.
MannKind Chief Medical Officer David Kendall commented, “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. We believe this study will allow for rapid evaluation of treprostonil dosing and therapeutic use in pulmonary arterial hypertension. If successful, this Phase 1 study will lead to registration studies in 2019.”
Kendall, who was most recently Research Physician and VP of Global Medical Affairs at Lilly Diabetes and is a former Chief Scientific and Medical Officer at the American Diabetes Association, joined the company in February 2018.
Read the MannKind press release on the TreT Phase 1 study.
Read the MannKind press release on David Kendall
