MannKind Completes Phase 1 Clinical Trial On Treprostinil Product
MannKind Corporation today 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.
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, MannKind is 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 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.
“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 MannKind was safely able to achieve higher plasma levels than reported for the current standard of care using Technosphere-based treprostinil,” stated Lewis Rubin, MD, Emeritus Professor of Medicine at the University of California, San Diego School of Medicine.
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.