Kaleido Biosciences Announces Initiation of Dosing in Non-IND Clinical Studies in Patients with Urea Cycle Disorders and Cirrhosis
Studies are evaluating novel Microbiome Metabolic Therapies, KB195 and KB174, in target patient populations; data expected in Q4 2019
Third non-IND clinical study in healthy subjects also underway to evaluate dosing of KB174
The gut microbiome plays a significant role in the production and consumption of ammonia, which is central to the pathogenesis of several ammonia processing-related diseases. KB195 and KB174 are novel Microbiome Metabolic Therapy (MMT™) product candidates intended to reduce net ammonia production by modulating the metabolic output and profile of the microbiome.
“As we continue to advance the development of our novel MMTs, we are pleased to have initiated dosing in these patient studies and anticipate results during the fourth quarter of 2019,” said
KB195 Non-IND Clinical Study in UCD
Urea cycle disorders (UCD) are a group of serious, 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 non-IND clinical study is expected to enroll approximately 5 UCD patients aged 14 and older on standard of care, who will receive KB195 orally for 21 days. The study will 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 the blood and urine.
Additional information on this study can be found at https://clinicaltrials.gov/ using identifier NCT03797131.
KB174 Non-IND Clinical Study in Cirrhosis
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, maltodextrin, in adult patients with well-compensated cirrhosis. Approximately 36 patients are expected to be enrolled and following an amino acid challenge will be randomized to receive either KB174 or maltodextrin orally for 28 days. This study will evaluate nitrogen metabolism in the blood and urine, and safety and tolerability.
Additional information on this study can be found at https://clinicaltrials.gov/ using identifier NCT03855956.
KB174 Non-IND Clinical Study in Healthy Subjects
Kaleido has also initiated dosing in a non-IND clinical study to evaluate various dosing levels of KB174 in healthy subjects in a model designed to assess nitrogen metabolism. Approximately 48 subjects will be randomized to one of four different dose groups and receive KB174 orally for 20 days. Following a protein challenge, markers of nitrogen metabolism in the blood and urine will be measured, and safety and tolerability will also be evaluated.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the therapeutic potential of our MMT candidates and our strategy, business plans and focus. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to the non-IND clinical study for KB195 for the treatment of UCD, non-IND clinical study for KB174 for the treatment of cirrhosis as well as non-IND clinical study of KB174 in healthy volunteers to study dosing, including statements regarding the timing for receipt of data from such studies and potential future studies, the clinical development and safety profile of our MMT candidates and their therapeutic potential, whether and when, if at all, our MMT candidates will receive approval form the U.S. Food and Drug Administration and for which, if any, indications, competition from other biotechnology companies, and other risks identified in our SEC filings, including our final prospectus for our initial public offering, and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.
Source: Kaleido Biosciences