Kaleido Biosciences develops what it calls ‘synthetic glycans’ with the aim to affect the microbiomes of consumers. Glycan is another word for polysaccharide. Kaleido also uses the term oligosaccharide as a keyword to refer to its research. The molecules have received more attention in the past decade, with a 2012 report for the National Academies of Science, Engineering and Medicine calling for more research into this class of compounds that promises “great advances in areas as diverse as medicine, energy generation, and materials science.”
The US Food and Drug Administration sent the warning letter to the company recent over “objectionable conditions” it observed during an inspection earlier this year of the company’s facilities in Lexington, MA. These related to the way the company organized two trials with a candidate molecule dubbed KB109.
FDA views trials has having drug endpoints
One trial was an open label parallel group study that aimed to compare the effect of KB109 the gut microbiota structure and function for patients with mild to moderate COVID-19 symptoms as compared to patients undergoing what was referred to as ‘supportive self care.’ The other trial was a single group, open-label study aimed at evaluating the physiological effects of the molecule in a similar group. In both cases the subjects were not hospitalized.
In FDA’s view, the structure of the trials implied a disease treatment endpoint, so an Investigational New Drug (IND) application should have been filed. According to the Agency, the firm argued in a response to the initial inspection findings that the nature of KB109 meant that an IND was not needed.