Kaleido Biosciences, Inc. KLDO reported encouraging results from a study on KB109 in patients with mild-to-moderate COVID-19.

KB109 is a novel, orally-administered product candidate based on the company’s Microbiome Metabolic Therapy (MMT) platform. The study was a multi-center, open-label, controlled clinical study of 350 patients, of which 181 received KB109 plus self-supportive care and 169 received self-supportive care alone.

Results from a non-Investigational New Drug (IND) study of KB109 in these patients showed a reduction in overall COVID-19-related healthcare utilization, comprising hospitalizations, emergency room visits and urgent care visits. Importantly, the study also demonstrated a significant reduction in recovery time for patients aged 45 years or older or with one or more comorbidities, who received KB109 plus self-supportive care as compared to patients receiving self-supportive care alone.

KB109 reduced healthcare utilization, as measured by the total number of hospitalizations, emergency room visits and urgent care visits, by approximately 62% among patients with one or more comorbidities and approximately 51% overall. For patients with one or more comorbidities, KB109 reduced the median time to resolution of the 13 overall COVID-19 symptoms from 30 to 21 days.

Per the company, KB109 targets the host immune system rather than the virus and is therefore likely to demonstrate similar results against emerging virus variants, though this has not yet been studied in an IND trial. As the pandemic continues to create havoc, oral therapies that reduce the duration of symptoms in patients with COVID-19 are in great need.

Kaleido intends to file an Investigational New Drug (IND) application, with the goal of advancing KB109 directly to a pivotal registration program soon. The mechanism of KB109’s induction of short-chain fatty acid production has been validated in multiple preclinical studies across both viral and bacterial respiratory pathogens.

Most biotech/pharma companies are evaluating every weapon in their arsenal to combat and prevent the spread and help the infected.

Kaleido’s stock has lost 9.7% in the year so far compared with the industry's decline of 3.5%.

Regeneron’s REGN investigational antibody cocktail for COVID-19 has shown efficacy against emerging variants. It was granted an Emergency Use Authorization in November 2020 for the treatment of mild-to-moderate COVID-19 in adults as well as pediatric patients at least 12 years of age and weighing at least 40 kg.

Earlier, Vir Biotechnology, Inc. VIR and partner GlaxoSmithKline plc GSK also obtained a favorable recommendation from the Independent Data Monitoring Committee (IDMC) for its late-stage study evaluating VIR-7831 (GSK4182136) as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization, recommending they pause enrollment due to evidence of profound efficacy.