Kaleido Biosciences Announces New Clinical and Preclinical Data Supporting Advancement of KB295 to a Phase 2 Clinical Study in Mild-to-Moderate Ulcerative Colitis
Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage biotech company with a differentiated, small-molecule approach to treating inflammatory conditions and diseases by selectively targeting the resident microbiome to restore gut-immune homeostasis, today announced topline data from the non-IND/CTA clinical study evaluating KB295, a novel Microbiome Metabolic Therapy (MMT?), in mild-to-moderate ulcerative colitis (UC). The primary objective of safety and tolerability was achieved as KB295 was well tolerated and no safety concerns were observed. In the study, subjects receiving KB295 experienced a reduction in three biomarkers, fecal calprotectin (FCP), fecal lactoferrin, and FimH that are known to be associated with UC disease activity. These results are complemented by preclinical studies conducted with Kaleido?s unique translational?ex vivo?platform using human donor-derived microbiome communities.
Highlights from the Topline KB295 Dataset for Mild-to-Moderate in UC
Clinical Data Observed at the End of an Eight-Week Intake Period
- Achieved primary objective of safety and tolerability with KB295 being well tolerated across subjects (n=12) with no product-emergent serious adverse events reported
- Observed a meaningful reduction in three key biomarkers: FCP, fecal lactoferrin, and FimH, known to be strongly correlated with inflammation and disease activity:
- Median FCP levels decreased by 69% in subjects with evaluable FCP (n=11), and 74% in subjects identified as responders (8 of 11); responders were defined as those subjects with FCP reduction greater than 50%
- Fecal lactoferrin decreased by a median of 69% in subjects with currently available samples (n=6), including five out of six subjects with a reduction of at least 50%
- FimH decreased by a median of 93% in subjects evaluated with currently available samples (n=5)
- Further fecal lactoferrin and FimH analysis is expected as additional subject samples become available
- Ex-vivo?data demonstrated community-wide changes and desired modulation of multiple remission-associated taxa
- Total short chain fatty acid (SCFA) production increased in?ex-vivo?studies to levels that are pharmacologically relevant to UC
- Observations from both preclinical and clinical data support the Company?s plans to initiate a phase 2 study, under an Investigational New Drug (IND) application and Clinical Trial Application (CTA), with KB295 for mild-to-moderate UC patients in the first half of 2022
- Manufacturing and toxicity work has commenced to support future studies under CTA and IND applications