Kaleido Biosciences Announces Completion of Enrollment of 350 Subjects in Controlled Study of KB109 in the Treatment of Mild-to-Moderate COVID-19
Topline data for two studies of KB109 are expected in the first quarter of 2021
LEXINGTON, Mass., Jan. 04, 2021 (GLOBE NEWSWIRE) -- Kaleido Biosciences, Inc. (Nasdaq: KLDO), today announced that completion of enrollment of 350 subjects in the controlled clinical study K031 evaluating Microbiome Metabolic Therapy (MMT™) candidate KB109 in the treatment of mild-to-moderate COVID-19. The multi-center, non-IND clinical study is designed to evaluate the effects of KB109 plus supportive self-care (SSC) compared to SSC alone for outpatients who are positive for SARs-Cov-2 and have symptoms. Study endpoints include safety and tolerability, biomarkers of the inflammatory response, and time to resolution of symptoms.
“This study, which seeks to better understand the potential of KB109 in COVID-19 and expand our understanding of its applicability to other viral infections, is the largest study to be conducted by Kaleido to date,” commented Dan Menichella, President and Chief Executive Officer of Kaleido. “Reaching this point of full enrollment positions us to deliver on the goal of reporting topline results later this quarter. We also continue to expect topline data from our smaller study of KB109 in the first quarter of 2021. The progress of our KB109 studies is highly encouraging and we see significant, broad potential for the MMT mechanism of action of improving the immune response to infection.”
The Kaleido KB109 development program involves two controlled, non-IND clinical studies including one study of 350 patients evaluating symptom resolution and one study of approximately 50 patients evaluating effects on microbiome composition and biomarkers of inflammatory response. Subjects are randomized to either receive SSC (the control group) or SSC plus KB109 for two weeks and then followed for a further three weeks. KB109 was selected for evaluation in COVID-19 studies based on its ability to increase microbiome production of short chain fatty acids, which act as modulators of the immune response.
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/.
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 clinical 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 from 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.
William Duke, Jr.
Chief Financial Officer