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MannKind (NASDAQ:MNKD) said clofazimine inhalation suspension (MNKD 101) will advance to an adaptive phase 2/3 study.
In addition, the company noted that a paper was published in the American Society for Microbiology journal Antimicrobial Agents and Chemotherapy examining the potential of treating nontuberculous mycobacterial (NTM) infection through direct delivery of inhaled clofazimine to the lungs, overcoming the systemic toxicity witnessed in oral treatments.
MannKind said direct delivery of clofazimine to the lungs may provide a treatment option for NTM lung disease which potentially overcomes systemic toxicity and lessens side effects.
“We are encouraged by the preclinical and Phase 1 data, and how inhaled clofazimine may finally resolve these issues, and most importantly, provide patients with a potentially improved NTM therapy,” said MannKind CEO Michael Castagna.
A 28-day preclinical toxicology study included toxicokinetic analyses on days 29, 56, and 84. The data showed significant residual drug in lung tissue, and long lung residence post-dosing at all three dose levels, according to the company.
Drug concentrations in the lung remained well above the average NTM minimum inhibitory concentration at all time points, with measurable clofazimine levels at 28 days and 56-days post-dosing, the company noted.
The phase 1 study, dubbed MKC-CI-001, was a placebo-controlled, single- (SAD) and multiple-ascending dose (MAD) trial to evaluate MNKD-101.
The company said clofazimine inhalation solution was seen to be generally well tolerated at daily doses of up to 90 mg.
No lab abnormalities, QT prolongation or serious adverse events were identified, according to MannKind.
