MannKind Shares Fall After Completing Initial Stage Lung Disease Study

MannKind Corporation MNKD has successfully completed a Phase 1 study of clofazimine inhalation suspension (MNKD 101), an inhalation treatment option for nontuberculous mycobacterial (NTM) lung disease.

The Phase I clinical trial is a single- (SAD) and multiple-ascending dose (MAD) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of MNKD-101 in healthy volunteers.

In the single-ascending dose (SAD) portion of the study, 24 adults were enrolled in one of three cohorts (n = 8 per cohort) that received a single inhaled dose of 30 mg, 60 mg or 90 mg clofazimine.

During the multiple-ascending dose (MAD) portion of the study, 16 adults were enrolled in one of two cohorts (n = 8 per cohort) that received a daily inhaled dose of 30 mg or 90 mg clofazimine for a seven-day period.

Michael Castagna, Chief Executive Office, commented: "There is a high unmet need to develop medicines that are well tolerated and effective in alleviating symptoms for those living with NTM lung disease. As we continue to expand our orphan lung diseases focus at MannKind, we are encouraged by what we are seeing with inhaled clofazimine and the future potential to help patients."

The company is planning discussions with the U.S. Food and Drug Administration (FDA) regarding results and the ongoing clinical program.

MannKind anticipates to share detailed data readouts in upcoming publications and scientific conferences.

Nontuberculous mycobacteria (NTM) lung disease is a serious infection that is caused by bacteria common in the environment that can lead to a reduction in lung function, cough, fatigue, and quality of life.

Price Action : MannKind shares are trading around down 3 percent at $3.69 on Tuesday at the time of publication.