MannKind Successfully Completes Phase 1 Trial of Treprostinil Technosphere for Pulmonary Arterial Hypertension Advancing Development to Next Phase
- Study achieved primary endpoint of safety and tolerability
- Progressive dosing of Treprostinil Technosphere (TreT) significantly exceeded the corresponding peak plasma and exposure levels of the maximum recommended dose of Tyvaso® Inhalation Solution
- Achieved a maximum tolerated dose with no serious adverse events reported
The key highlights of this study are:
- Ability to deliver TreT within 1-2 inhalations in <10 seconds
- Maximum tolerated dose is expected to be able to deliver higher plasma concentrations above the reported data for the current commercially available inhaled treprostinil
- Based on these data,
MannKindis preparing the next phase of development to evaluate the safety and tolerability of TreT in patients with PAH
- Data will be submitted to be presented at an upcoming conference
“We are pleased to have completed the TreT Phase 1 trial, which met the study’s safety, tolerability and pharmacokinetics objectives,” stated
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
“People living with PAH need more convenient and tolerable treprostinil treatment options to help them live a less intrusive lifestyle. I am excited to see that
This was a single site study with 48 healthy, normal subjects enrolled in 8 cohorts of 6 subjects each. The treatments were intended to establish the maximum tolerated dose, starting at 30 mcg. Each subject received one dose of TreT by oral inhalation during the treatment period. A total of 12 pharmacokinetic blood samples were collected from each subject. Plasma pharmacokinetic samples were analyzed for treprostinil.
The primary objective of the Phase 1 clinical study was to investigate the safety, tolerability, and pharmacokinetics of TreT in healthy volunteers after dosing by oral inhalation. Secondary endpoints include the evaluation of systemic exposure and pharmacokinetics of TreT, including dose proportionality. For more information about the study, please visit www.ClinicalTrials.gov.
About Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension (PAH) is a chronic, progressive disease characterized by abnormally high blood pressure in the pulmonary arteries between the heart and lungs of an affected individual. Over time, this can cause increased strain on the heart, leading to right-heart failure. Symptoms of PAH include shortness of breath, dizziness and fatigue, which grow more severe as the disease progresses. PAH represents Group I within the Pulmonary Hypertension WHO clinical classification system and is one of five such groups.
Statements contained in this press release that are not strictly historical in nature are forward-looking statements that involve risks and uncertainties. These statements include, without limitation, statements regarding
SVP, Investor Relations