• The FDA has issued a warning letter to Kaleido Biosciences Inc (NASDAQ: KLDO), blasting its “failure to submit Investigational New Drug applications for a clinical trial with an investigational new drug” that falls under section 505.

• Related Content: Kaleido Reports Positive KB109 Data In COVID-19 Study.

• Kaleido has 15 days to explain itself.

• According to the letter, Kaleido was well aware of the FDA’s objections.

• Regulators received a response, in which Kaleido argued that KB109, the synthetic glycan being tested in the study, was in fact “a food rather than a drug.”

• Kaleido stated that subjects were instructed to follow CDC guidelines and supportive self-care (SSC) measures to manage COVID-19 symptoms and argued that KB109, therefore, was given for nutritional purposes and was not studied as a COVID-19 treatment.

• The protocol, dubbed Protocol K031-120 and Protocol K032-120, and Kaleido’s press releases suggested otherwise, the FDA said.

• Kaleido’s objective was to compare the safety and efficacy of KB109 in combination with supportive self-care against supportive self-care alone.

• It also measured participants’ symptoms and healthcare utilization, like biomarkers and their gut microbiome structure.

• The FDA wrote that the argument for describing KB109 as a medical food fails because no distinctive nutritional requirements have been established for COVID-19, which is a prerequisite for defining medical food.

• Price Action: KLDO stock is down 5.19% at $6.03 during the market session on the last check Tuesday.

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