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KLDO

Kaleido Biosciences

$5.12 /

-0.07 (-1.35%)

08:09
12/12/19
12/12
08:09
12/12/19
08:09

Kaleido Biosciences announces top-line results from PoC study of KB174

Kaleido Biosciences announced top-line results from a proof-of-concept clinical study of KB174 using a 15N-labeled tracer in patients with well-compensated cirrhosis. Compared to baseline, treatment with KB174 was associated with a 26 percent reduction in urinary 15N excretion, a biomarker of microbiome ammonia production, and was well tolerated. KB174, a novel Microbiome Metabolic Therapy designed to modulate the metabolic output and profile of the microbiome, was identified as Kaleido's lead candidate in HE for its ability to lower both ammonia and multi-drug resistant pathogens ex vivo. The gut microbiome plays a significant role in the production of ammonia. Ammonia is central to the pathogenesis of several diseases, including HE, which encompasses a spectrum of potentially reversible neurologic and psychiatric abnormalities generally seen in patients with liver disease. HE is a common complication of all forms of cirrhosis, leading to significant morbidity and mortality in this patient population. Patients with cirrhosis also have an increased risk of developing bacterial infections, and infection can cause an episode of HE. Forty adult patients with liver disease were enrolled in this double-blind, controlled clinical study. Patients were randomized to receive KB174 or maltodextrin, orally for 28 days. A lactose-15N-ureide tracer was administered after an amino acid challenge both before and after treatment to evaluate changes in nitrogen metabolism in the gut. A reduction of this 15N tracer in the urine is considered a marker of a reduction in net ammonia production by the gut microbiome. Patients were also followed for measures of safety and tolerability. Twenty-nine evaluable patients meeting the threshold for cirrhosis were included in the per protocol 15N tracer analyses. Patients treated with KB174 had a 26 percent median reduction in urinary 15N excretion compared to baseline versus a 3 percent median reduction for those receiving maltodextrin. KB174 was well tolerated and no clinically significant or serious treatment-related adverse events were observed. Treatment-related adverse events were mild to moderate in severity in both groups and generally GI-related. Patients on KB174 reported only small changes in the Gastrointestinal Tolerability Questionnaire and the Bristol Stool Scale with no notable differences compared to maltodextrin. The Company plans to present additional data from this clinical study at a future medical meeting. The Company also announced completion of a dosing study of KB174 in 48 healthy subjects. Results were consistent with the study in patients with cirrhosis, and KB174 was well tolerated with no clinically significant or serious treatment-related adverse events. Due to operational issues at the clinical site, urinary volumes required to calculate 15N excretion were recorded for only 15 of the 48 subjects, but a trend in dose response was observed for these subjects, with greater reductions in urinary 15N excretion observed at higher doses. Further analysis of study data utilizing imputed values for the remaining 33 subjects was conducted, and results were consistent with those of the smaller group. Kaleido continues to leverage its rapid and cost efficient human-centric discovery and development model, with recent feedback from the U.S. Food and Drug Administration that the Company may advance directly into a Phase 3 pivotal trial upon filing an Investigational New Drug application if the Company elects to do so. As a result, Kaleido expects to initiate its next study of KB174 evaluating clinical endpoints in patients with HE during the second half of 2020, ahead of a potential IND filing.

KLDO Kaleido Biosciences
$5.12 /

-0.07 (-1.35%)

03/25/19 ADAM
Kaleido Biosciences initiated with a Buy at Canaccord
03/25/19 MSCO
Kaleido Biosciences initiated with an Overweight at Morgan Stanley
03/25/19
Fly Intel: Top five analyst initiations
04/23/19 CHDN
Kaleido Biosciences initiated with a Buy at Chardan

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