Kaleido Biosciences Announces First Patient Dosed in Clinical Study of Microbiome Metabolic Therapy KB295 in Patients with Mild-to-Moderate Ulcerative Colitis
Kaleido Biosciences has commenced dosing the first patient in its clinical study for KB295, a Microbiome Metabolic Therapy (MMT™) candidate aimed at treating patients with mild-to-moderate ulcerative colitis (UC). The study seeks to evaluate the safety and tolerability of KB295, with top-line results anticipated in mid-2021. KB295 has shown potential in reducing inflammatory bacteria and increasing beneficial metabolites in prior studies. This open-label study will enroll around 30 patients over an eight-week period, examining various clinical and microbiome-related endpoints.
- Initiation of clinical study for KB295, showing progress in development.
- KB295 demonstrated ability to reduce inflammatory bacteria in earlier studies.
- The study targets a significant unmet medical need in ulcerative colitis treatment.
- The study is small, enrolling only approximately 30 patients, limiting data robustness.
- Dependence on the FDA approval process for the therapeutic development of MMT candidates.
Top-line safety, tolerability and activity results expected in mid-2021
LEXINGTON, Mass., Sept. 29, 2020 (GLOBE NEWSWIRE) -- Kaleido Biosciences, Inc. (Nasdaq: KLDO) today announced that the first patient has been dosed in its clinical study evaluating Microbiome Metabolic Therapy (MMT™) candidate KB295 in patients with mild-to-moderate ulcerative colitis (UC).
“Alteration of the gut microbiome plays an important role in the development of UC,” said Katharine Knobil, M.D., Kaleido’s Chief Medical Officer and Head of Research & Development. “Our research with patient samples demonstrates that KB295 decreases pro-inflammatory species and promotes the production of beneficial metabolites in the gut microbiome that may impact the progression of UC. We look forward to evaluating the potential of KB295 in UC in this clinical study, with top-line data from the study expected in mid-2021.”
UC is an inflammatory bowel disease that can cause debilitating symptoms, including abdominal pain, bowel urgency and diarrhea. Evidence suggests that a feature of UC is alteration of the gut microbiome, including an increase in inflammatory bacteria and decrease in commensal diversity which interfere with the normal immune response. In ex vivo studies, KB295 has demonstrated the ability to increase the production of short chain fatty acids and suppress the growth of inflammatory bacteria such as Enterobacteriaceae.
“There is a growing body of evidence supporting the potential to address inflammatory diseases like UC by influencing the microbiome,” said Ted Dinan, M.D., Ph.D., Medical Director of Atlantia Food Clinical Trials Ltd and Principal Investigator at the APC Microbiome Ireland Research Center at University College Cork. “We see significant promise for KB295 in the treatment of UC with the field of microbiome-directed approaches because of its distinctive mechanism targeting microbiome metabolism and function.”
This non-IND/non-CTA open label, single arm clinical study is expected to enroll approximately 30 patients with mild-to-moderate UC. Patients will receive KB295 for eight weeks titrated up to 40 g twice daily and then enter a one-month follow-up period. The study will evaluate the safety and tolerability of KB295 and other assessments including the Simple Clinical Colitis Activity Index (SCCAI) composite score, changes in microbiome composition and biomarkers of inflammation.
About Microbiome Metabolic Therapies (MMT™)
Kaleido’s Microbiome Metabolic Therapies, or MMTs, are designed to drive the function and distribution of the microbiome’s existing microbes in order to decrease or increase the production of metabolites, or to advantage or disadvantage certain bacteria in the microbiome community. The Company’s initial MMT candidates are targeted, synthetic glycans that are orally administered, have limited systemic exposure, and are selectively metabolized by enzymes in the microbiome. Kaleido utilizes its discovery and development platform to study MMTs in microbiome samples to rapidly advance MMT candidates rapidly into clinical studies in healthy subjects and patients. These human clinical studies are conducted under regulations supporting research with food, evaluating safety, tolerability and potential markers of effect. For MMT candidates that are further developed as therapeutics, the Company conducts clinical trials under an Investigational New Drug (IND) or regulatory equivalent outside the U.S., in Phase 2 or later development.
About Kaleido Biosciences
Kaleido Biosciences is a clinical-stage healthcare company with a differentiated, chemistry-driven approach to targeting the microbiome to treat disease and improve human health. The Company has built a proprietary product platform to enable the rapid and cost-efficient discovery and development of novel Microbiome Metabolic Therapies (MMT™). MMTs are designed to modulate the metabolic output and profile of the microbiome by driving the function and distribution of the gut’s existing microbes. Kaleido is advancing a broad pipeline of MMT candidates with the potential to address a variety of diseases and conditions with significant unmet patient needs. To learn more, visit https://kaleido.com/.
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, the timing of initiation, completion and reporting of results of our clinical and preclinical studies 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 breadth of our pipeline of product candidates, the strength of our proprietary product platform, the efficiency of our discovery and development approach, 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 most recent Form 10-Q, 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.
Contacts
Kaleido Biosciences
William Duke, Jr.
Chief Financial Officer
617-890-5772
william.duke@kaleido.com
Investors
Lee M. Stern
Solebury Trout
646-378-2922
lstern@soleburytrout.com
Media
Rich Allan
Solebury Trout
646.378.2958
rallan@troutgroup.com
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