MannKind is set to start patient enrolment in a Phase I clinical trial of Treprostinil Technosphere (TreT) for the treatment of pulmonary arterial hypertension (PAH).
The trial will be carried out under an investigational new drug (IND) application filed with the US Food and Drug Administration (FDA).
Its primary endpoint is to evaluate the safety, tolerability, and pharmacokinetics of TreT in healthy volunteers after dosing by oral inhalation.
Secondary objectives of the trial include the assessment of systemic exposure and pharmacokinetics of TreT, including dose proportionality.
MannKind chief medical officer Dr David Kendall said: “We believe this study will allow for rapid evaluation of treprostonil dosing and therapeutic use in pulmonary arterial hypertension.
“If successful, this Phase I study will lead to registration studies in 2019.”
TreT is being currently investigated as a drug-device combination product for the treatment of patients with PAH, using a small, portable, breath-powered inhaler that is intended to simplify drug dosing.
PAH is a rare, chronic, progressive, and fatal disease, is caused by the hardening and narrowing of the pulmonary arteries, which results in abnormally high blood pressure in these arteries, and leads, with time, to heart failure.
The symptoms of PAH are shortness of breath, dizziness, and fatigue that are tend to grow more severe as the disease progresses.
PAH patients experience severe restrictions on their exercise capacity, reduced quality of life, and a shorter life-expectancy.
Currently, there is no cure available for PAH. Existing treatments for the disease can only manage the symptoms.