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Danbury biopharma firm halts late-stage drug trial after disappointing results

A Connecticut-based drug developer has halted a key late-stage clinical trial after early data showed its experimental inhaled antibiotic was unlikely to succeed, according to a recent federal filing.

Danbury-based MannKind Corp. ended its Phase 3 study testing MNKD-101, a nebulized form of clofazimine, for a rare lung infection known as refractory nontuberculous mycobacterial (NTM) disease. An interim analysis found none of the 46 patients who completed the trial achieved the desired response, prompting both the company and an independent safety board to conclude the study would not meet its primary goal.

The decision was not related to safety issues, MannKind said.
Chief Medical Officer Ajay Ahuja said the company was “disappointed that the nebulized formulation did not demonstrate efficacy,” but added that MannKind remains optimistic about MNKD-102, a dry-powder version of the same drug that is advancing toward early human testing.

The company, best known for its inhaled insulin Afrezza, plans to redirect resources toward other respiratory and endocrine programs, including the development of MNKD-102. No job reductions or broader restructuring were announced.

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At the end of last year, MannKind said it had 407 employees, of which 403 were full-time. Of its full-time employees, 238 were engaged in manufacturing, 23 in research and development and 142 in selling, general and administrative, according to the company’s annual report.

MannKind, which trades publicly on the Nasdaq, saw its stock price fall 5.7% to $5.32 as of 11:30 a.m.

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