FDA hands Kaleido Biosciences a warning letter 

The FDA notified Kaleido Biosciences (NSDQ:KLDO) determined that the Lexington, Massachusetts-based company did not submit investigational new drug (IND) applications for clinical trials related to the investigational drug KB109, a microbiome modulator.

The two clinical trials in question, dubbed “Protocol K031-120” and “Protocol K032-120,” are testing KB109 in adults with mild-to-moderate COVID-19.

KB109 is a synthetic glycan.

After getting a Form FDA 483 earlier this year, the company responded to FDA that it did not need to submit an IND because KB109 was a food rather than a drug. In particular, the clinical two trials could “enhance [Kaleido’s] understanding of the distinct nutritional requirements (DNR) that may exist in individuals with [viral respiratory] illnesses such as COVID-19 and would support the positioning of KB109 as a medical food,” the company said in its response to FDA.

A slide deck from the company refers to one of the trial…

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