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 human clinical studies under regulations supporting research with food. In these clinical studies, we are able to evaluate safety and tolerability and potential markers of effect, which allows us to assess the overall promise of our MMT candidates. If after completing clinical studies under regulations supporting research with food we decide to pursue an MMT candidate as an investigational drug product, we will conduct clinical trials under an IND, or the regulatory equivalent outside the U.S., 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 enrolling 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.
MDR pathogens are a significant and growing global health threat. The CDC has estimated that in the U.S. each year, more than 2.8 million antibiotic-resistant infections occur and more than 35,000 people die from these infections. Colonization with MDR pathogens leads to a higher risk of serious infections.
The VITORA clinical study is enrolling patients colonized with MDR pathogens (including VRE, CRE and ESBLs) and will evaluate the effect of KB109 on reducing the relative abundance of pathogens and assess its safety and tolerability.
*Human clinical study conducted under regulations supporting research with food.
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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