Three non-investigational New Drug clinical studies are underway for Urea Cycle Disorders (UCD) and various forms of cirrhosis, initiated by Kaleido Biosciences. Dosing has been initiated in each of these trials.
The company is evaluating two different Microbiome Metabolic Therapy (MMT) products. These work to reduce ammonia production.
The first clinical trial is examining KB195 in UCD.
UCD is caused when the body is deficient in either one of the amino acid transporters or one of the enzymes which make up the urea cycle. This deficiency makes the body struggle to process ammonia properly. Patients in this trial will be given an oral dose of KB195 for 21 days. The effect of this treatment on the body’s ammonia levels will be measured. Additionally, the safety and the tolerability of the therapy will be monitored.
A total of 5 patients will be enrolled. Participants must be at least 14 years of old and be currently on standard of care treatment.
The second clinical trial is investigating KB174 in cirrhosis patients. Specifically, it aims to evaluate the effect KB174 could have on encephalopathy caused by the condition. To do so, it will compare KB174 to maltodextrin, a negative control.
It plans to enroll 36 cirrhosis patients. These individuals will be randomized to determine whether they will be given maltodextrin or KB174. The treatment period will last for 28 days during which safety, tolerability, and nitrogen metabolism will be evaluated.
The third clinical trial is investigating KB174 in healthy volunteers. It’s goal is to evaluate different dosage amounts of KB174 on nitrogen metabolism. The trial will enroll 48 participants. These individuals will be given one of four dose amounts of KB174. The treatment period will last for 20 days, during which safety, tolerability, and nitrogen metabolism will be monitored.
The results from all three of these trials should be received by the fourth quarter of this year.
Kaleido has also announced that they have another Phase 2 study for UCD planned for this year. It will be an IND study also evaluating their MMT products. Additionally, one more non-IND study for a different MMT called KB109 will begin in 2019.
The company is extremely excited about these trials, and hopeful about the impact their MMT products could have on these patient populations.
You can read more about these clinical trials here.