Kaleido Biosciences Provides Update on KB109 Clinical Data Timeline
Kaleido Biosciences (Nasdaq: KLDO) announced updates on its COVID-19 clinical development program, focusing on KB109 for outpatients with mild-to-moderate disease. The enrollment target for the K031 study has increased to 350 patients, with top-line data now expected in Q1 2021, delayed from Q4 2020. Meanwhile, results from the K032 study with about 50 patients are also anticipated in Q1 2021. The company is adapting protocols for virtual visits due to COVID-19 impacts. Other ongoing studies include KB295 for ulcerative colitis and KB195 for urea cycle disorder, with results expected in mid-2021 and H2 2021, respectively.
- Update on KB109 clinical study shows increased enrollment target to 350 patients.
- Top-line data from K031 study now expected in Q1 2021, indicating continued progress.
- K032 study results expected in Q1 2021, showcasing ongoing clinical trials.
- Delay in K031 study timeline from Q4 2020 to Q1 2021 may signal challenges in recruitment.
LEXINGTON, Mass., Oct. 06, 2020 (GLOBE NEWSWIRE) -- Kaleido Biosciences, Inc. (Nasdaq: KLDO), today announced an update to its ongoing COVID-19 clinical development program evaluating KB109 when added to supportive self-care (SSC) in outpatients with mild-to-moderate COVID-19 disease. Updated projections for enrollment of the multi-center K031 clinical study of approximately 350 patients indicated that top-line data will be available in the first quarter of 2021. Previous projections had indicated the potential availability of top-line data from the study in the fourth quarter of 2020.
“We are encouraged by the potential for KB109, a novel glycan developed with our MMT approach, to influence clinical outcomes in patients with COVID-19,” commented Michael Bonney, Executive Chair of Kaleido. “This delay in our timeline for the K031 study, while unexpected, is understandable given the dynamic nature of this emergent disease and the nature of its spread in different geographies. Results of our K032 clinical study of KB109 in approximately 50 patients with mild-to-moderate COVID-19, conducted in collaboration with Massachusetts General Hospital, continue to be expected in the first quarter of 2021. Guidance for our other programs is unchanged, with data from our study of KB295 in ulcerative colitis expected in mid-2021, results with KB195 in urea cycle disorder expected in the second half of 2021. With our clinical studies, we have instituted protocols to allow for virtual visits to reach patients who may not be near a study site or when needed in order to minimize the impact of disease transmission on study enrollment. In addition, we continue to expect preclinical data from our immuno-oncology, cardiometabolic and liver diseases programs this quarter (the fourth quarter of 2020).”
Additional information about the K031 study of MMT therapy KB109 in outpatients with mild-to-moderate COVID-19 infection is available at https://clinicaltrials.gov/ct2/show/NCT04414124. Information about the K032 study is available at https://clinicaltrials.gov/ct2/show/NCT04486482.
A patient may be eligible for enrollment in these studies if an initial positive COVID-19 test result is received and the patient remains symptomatic.
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 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 and the timing of completion and reporting of results of clinical studies. 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.
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@soleburytrout.com
FAQ
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