- MannKind Corporation ( NASDAQ: MNKD ), a biotech focused on rare lung diseases, added ~10% in the pre-market trading Tuesday in reaction to its plans to further develop clofazimine inhalation suspension for nontuberculous mycobacterial (NTM) lung disease.
- With the disclosure, the company also shared Phase 1 data for the candidate, also known as MNKD 101, which is undergoing studies for NTM lung disease, a severe infection caused by bacteria commonly found in the environment.
- The early-stage trial named MKC-CI -001 was designed to evaluate MNKD-101 in 40 healthy volunteers who were part of single- (SAD) and multiple-ascending dose (MAD) portions that tested up to 90mg doses of clofazimine.
- According to the results, the experimental therapy was generally well tolerated at daily doses of up to 90 mg over seven days, MNKD said, adding that the company plans to meet the FDA to discuss the results and the ongoing studies of clofazimine.
- Final analysis of additional data from the trial is underway, with plans to disclose detailed results in the future.
For further details see:
Mannkind to further advance lung disease candidate after positive Phase 1 data