LEXINGTON - Kaleido Biosciences, Inc. (Nasdaq: KLDO) today reported positive results from a non-IND study of KB109 in patients with mild-to-moderate COVID-19.

An analysis from the full dataset demonstrated a reduction in overall COVID-19 related healthcare utilization-comprised of hospitalizations, emergency room visits, and urgent care visits. The study also demonstrated a significant reduction in recovery time for patients age 45 and older or with one or more comorbidity who received KB109 plus self-supportive care as compared to patients receiving self-supportive care alone. The study was a multi-center, open label, controlled clinical study of 350 patients in which 181 received KB109 plus self-supportive care and 169 received self-supportive care alone. KB109 is a novel, orally administered product candidate based on the Company's Microbiome Metabolic Therapy (MMT) platform.

Summary of Results

Primary Endpoint: KB109 demonstrated an overall favorable safety and tolerability profile with no unexpected treatment-related adverse events.

KB109 reduced healthcare utilization, as measured by the total number of hospitalizations, emergency room visits, and urgent care visits by approximately 62 percent among patients with one or more comorbidity and by approximately 51 percent overall.

KB109 showed the greatest impact for patients with one or more underlying comorbidity, who have a considerably longer disease course.

For patients with one or more comorbidity, KB109 reduced median time to resolution of the 13 overall COVID-19 symptoms from 30 to 21 days (HR=1.422 [95% CI: 0.898, 2.250]; p=NS).

In an exploratory analysis of patients ages 45 and older or with one or more comorbidity, KB109 significantly reduced median time to resolution of the 13 overall COVID-19 symptoms from 31 to 21 days (HR=1.597 [95% CI: 1.064, 2.398]; p

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