At Kaleido, we are relentless in our drive to pursue rigorous science and pioneer new approaches that can transform lives. The microbiome remains a largely untapped frontier in healthcare, with a broad and growing body of research implicating it in a number of diseases and conditions. We are uniquely positioned to succeed in translating its promise into solutions for patients and caregivers. Our team is hard at work developing our Microbiome Metabolic Therapies (MMT™), which we believe have potential to be therapies across a variety of conditions. We invite you to learn more about our programs and clinical studies and how patients are at the heart of everything we do towards our mission of leading a revolution in human health.
We have built a 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. In initial clinical studies under regulations supporting research with food, 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 these initial clinical studies 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 includes UCD patients between the ages of 12 and 70 with inadequate control of their disease (defined as having elevated ammonia) on standard of care. The study will assess the effect of KB195 on reducing plasma ammonia levels and evaluate its safety and tolerability.
Controlled Clinical Studies of KB109 in Outpatients with Mild-to-Moderate COVID-19*
Many individuals who test positive for the SARs-Cov-2 virus experience mild-to-moderate COVID-19 disease and generally quarantine at home with self care, while others who experience more severe COVID-19 disease may be hospitalized. In these studies, individuals with mild-to-moderate COVID-19 will be randomly assigned to one of two at-home treatment groups: standard supportive self-care or self care plus KB109 taken orally. These studies will assess safety, clinical outcomes, healthcare utilization, and biomarkers of inflammatory response.
*Human clinical study conducted under regulations supporting research with food.