We have built a human-centric proprietary product platform for discovery and development that we believe will enable the rapid advancement of a broad portfolio of novel product candidates into non-Investigational New Drug (non-IND) human clinical studies under regulations supporting research with food. In these non-IND clinical studies, we are able to measure safety and tolerability and potential markers of effect, which allows us to assess the overall promise of our MMT candidates. If after completing non-IND clinical studies we pursue an MMT candidate as an investigational drug product, we will conduct clinical trials under an IND to evaluate its safety and effectiveness as a therapeutic in patients.
Urea cycle disorders (UCD) are a group of life-threatening, rare genetic diseases caused by a deficiency in one of the six enzymes or two amino acid transporters that constitute the urea cycle, resulting in an impaired ability to process ammonia.
This Phase 2 clinical trial is expected to initiate in the second quarter of 2019, and will enroll UCD patients with inadequate control of their disease (defined as having elevated ammonia) on standard of care and will assess the effect of KB195 on reducing plasma ammonia levels and evaluate its safety and tolerability.
This non-IND clinical study is designed to evaluate the safety and tolerability of KB195 in patients with UCD, as well as its effect on ammonia levels as measured by nitrogen metabolism in blood and urine.
Hepatic encephalopathy describes a spectrum of potentially reversible neurologic and psychiatric abnormalities generally seen in patients with liver failure. It is a common complication of all forms of cirrhosis, leading to significant morbidity and mortality in this patient population. Elevated ammonia in the blood is central to the pathologic process that causes encephalopathy.
This randomized, double-blind, controlled non-IND clinical study is designed to evaluate KB174 compared to a negative control in adult patients with well-compensated cirrhosis. It will evaluate nitrogen metabolism in the blood and urine, as well as safety and tolerability.
MDR pathogens are a significant and growing global health threat. In the United States alone, at least two million people per year are infected with bacteria resistant to antibiotics. Colonization with MDR pathogens leads to a higher risk of serious infections. This non-IND clinical study will evaluate the safety and tolerability of KB109 compared to control, as well as change in colonization of vancomycin-resistant Enterococcus (VRE), extended-spectrum beta lactamase(ESBL)-producing Enterobacteriaceae (ESBLs), and carbapenem-resistant Enterobacteriaceae (CRE).
Non-IND clinical study evaluating various doses of KB174 in healthy subjects
This non-IND clinical study is designed to evaluate various dosing levels of KB174 in healthy subjects in a model designed to assess nitrogen metabolism. Following a protein challenge, markers of nitrogen metabolism in the blood and urine will be measured, and safety and tolerability will also be evaluated.
Kaleido Biosciences is committed to developing new therapies for unmet medical needs. A key part of this development is testing our therapies in clinical trials to assess the safety and effectiveness of our investigational products in human subjects.
Expanded Access, sometimes called Compassionate Use, refers to a pathway in which patients with serious or immediately life-threatening diseases or conditions may gain access to an investigational product outside the context of participation in clinical trials when there are no comparable or satisfactory therapies available. For a sponsor to provide an investigational product as part of an Expanded Access Program is a complex matter and is different from studying the investigational product as part of a clinical trial, where more comprehensive safety and efficacy data are collected. We understand that under certain circumstances Expanded Access to our investigational products may be appropriate and may be considered.
Consistent with the Food and Drug Administration (FDA) and other regulatory agency guidelines regarding when Expanded Access may be considered, several factors are evaluated. Those factors include, but are not limited to:
At this time, Kaleido believes that participation in one of our clinical trials is the most appropriate way to access our investigational products. If you or a family member are interested in potentially gaining access to one of our investigational products, we encourage you to consult with your physician regarding the possibility of participating in our planned clinical trials. If you have additional questions, please speak with your physician or contact us via email at email@example.com. We anticipate acknowledging receipt of such inquiries sent to this email within five business days. We continue to work to advance our development programs to deliver innovative products to the largest number of patients in the shortest amount of time.
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