Kaleido warned; FDA not persuaded by 'medical food' claim
The US Food and Drug Administration (FDA) recently issued a warning letter to Kaleido Biosciences for administering an investigational new COVID-19 treatment to patients without obtaining an investigational new drug (IND) application.The company argued that the product under investigation was a food and not a drug, and therefore not subject to IND filing requirements. Yet the agency disagreed, saying that the endpoints used in the clinical trials went beyond ‘dietary management’ of COVID-19 and were more aligned with drug trials in assessing effectiveness of the treatment.
The 26 August warning letter was sent over “objectionable conditions” observed following a mid-February to early March inspection of Kaleido’s Lexington, MA facility, conducted under the auspices of FDA’s bioresearch monitoring program. At issue was the firm’s clinical investigation of a molecule called KB109 for treating COVID-19. The treatment is a microbiome metabolic therapy, a synthetic glycan that is orally administered for treating COVID-19.
The warning letter focused on two protocols, Protocol K031-120, and Protocol K032-120. The first trial was a randomized, open-label prospective parallel group study to assess the natural history of COVID-19 and compare the effect of the treatment in patients undergoing supportive self-care (SSC). The other trial was an exploratory open-label clinical study to evaluate how the treatment affected the gut microbiota of adult patients with mild to moderate COVID-19.
Between the two multi-site trials, 399 patients were randomized.
Kaleido argued it was not obligated to submit an IND before initiating these clinical investigations because KB109 is a food rather than a drug. Specifically, Kaleido argued that the investigations were conducted “to evaluate the effect of KB109 on the microbiome” and to “determine the safety and tolerability of KB109 in the disease population,” according to FDA’s characterization of the firm’s position.
These arguments failed to persuade FDA, which concluded that the “evidence collected during the inspection showed that KB109 was intended for use as a drug and not as a food.”
FDA maintained that “even if there were distinctive nutritional requirements established for COVID-19, Protocols K031-120 and K032-120 went beyond ‘dietary management’ of COVID-19 to evaluate KB109’s ability to treat COVID-19 by measuring the investigational product’s effects on fever, oxygen saturation, viral load, and other biomarkers of COVID-19 infection, among other things.”
Kaleido’s argument that KB109 is a medical food fails on other counts as well, wrote FDA. Since no particular nutritional requirements that might help manage COVID-19 have yet been discovered, KB109 cannot be used in the dietary management of the disease, as would be required for a product classified as a medical food.
Also, the fact that an article has been established to be generally recognized as safe (GRAS) does not preclude its use as a drug. FDA clarified that “an article may be a drug as used in a clinical trial, even if it is considered a food as used in other contexts.”
The company has 15 days to file a response.
Daniel Menichella, Kaleido’s chief executive officer, told Focus in an email that “we are reviewing the letter currently and look forward to providing a response within the given timeframe and continuing our discussions with the FDA.”
Kaleido warning letter
