Inhaled Delivery of Clofazimine - A High Efficiency, Flow Independent, Targeted, Low Cost DPI

NIH RePORTER · NIH · N44 · $2,999,221 · view on reporter.nih.gov ↗

Abstract

Inhaled Delivery of Clofazimine (CFZ) – An Important Anti-tuberculosis Drug: Development of improved drug regimens to shorten treatment for multidrug-resistant (MDR) and drug susceptible (DS) tuberculosis (TB) and improve tolerance and safety is an extremely high research priority. Clofazimine is a drug approved decades ago for treatment of leprosy. Animal studies of the drug for TB treatment indicate that it may significantly reduce treatment duration, particularly in combinations including PZA. The effectiveness of the “Bangladesh” regimen provides support that inclusion of CFZ in MDR regimens may shorten treatment from 18 to 9-10 months, at least in populations with a low rate of resistance to other MDR drugs. However, tolerance to orally administered clofazimine is often limited by skin discoloration and GI adverse events. In addition, CFZ substantially increased the QT interval. Inhaled delivery offers the potential to bypass these barriers while still maintaining effectiveness in the lungs by achieving high drug concentrations in the infected pulmonary tissue with lower systemic exposure, thus allowing increased immediate potency. The goal is to develop an inexpensive, easy-to-use, inhaled delivery system for clofazimine to be used with combinations of systemic anti-tubercular drugs to improve the treatment of MDR and DS TB.

Key facts

NIH application ID
10229327
Project number
272201800039C-P00001-9999-1
Recipient
VIA THERAPEUTICS, LLC
Principal Investigator
JOHN KOLENG
Activity code
N44
Funding institute
NIH
Fiscal year
2020
Award amount
$2,999,221
Award type
Project period
2018-08-15 → 2023-08-14