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Microbiome Therapy Shown to Cut Covid-19 Health Needs

Gut microbes

Gut microbes cultured in an artistic design (Nicola Fawcett, Wikimedia Commons)

25 Mar. 2021. A clinical trial shows a treatment targeting gut microbes reduces health care use and recovery times in people with mild to moderate Covid-19 disease. Findings from the trial were released by Kaleido Biosciences Inc. in Lexington, Massachusetts, developer of an experimental therapy code-named KB109, but are not yet peer-reviewed.

Kaleido Biosciences creates therapies for infectious, metabolic, and immune-related diseases, as well as cancer designed to act on the microbiome, microbial communities found naturally in the body, particularly in the gut. The microbiome is an emerging area of research and opportunity for therapies, including for diseases not usually associated with bacteria or the gut, including disorders linked to the immune system and neurological diseases.

Kaleido Bio develops its therapies with synthetic glycans, simple to complex carbohydrate compounds with many known interactions with microorganisms in the gut. The company says it maintains a library of more than 1,500 synthetic glycans designed to influence metabolic functions of gut microbes. From this library, Kaleido Bio develops treatment candidates it calls microbiome metabolic therapies, or MMTs designed to act on classes of gut microbes with enzymes to produce metabolites with therapeutic effects.

The company says its MMTs can be taken as oral drugs, and meet requirements set by the Food and Drug Administration for “generally accepted as safe” substances applied to food additives. As a result, says Kaleido Bio, MMTs can often bypass separate early-stage safety trials and be tested initially in mid-stage clinical studies.

KB109, says Kaleido Bio, consists of metabolites called short chain fatty acids that are known to influence immune responses. The company cites previous studies showing short chain fatty acids are linked to production of antibodies and T-cells in the immune system, and help reduce symptoms and improve survival in patients with severe respiratory infections, like those caused from the SARS-CoV-2 virus responsible for Covid-19.

No adverse effects from therapy reported

The clinical trial enrolled 350 adult participants from 16 sites in the U.S., within two days of testing positive for SARS-CoV-2 and exhibiting mild to moderate symptoms such as cough or fever. Participants were randomly assigned to receive KB109 along with their self-supported care, or only self-supported care. The study team looked primarily for adverse effects from KB109, but also the need for further health care interventions, such as visits to urgent care facilities or hospitals, and changes in symptoms for 35 days following treatment.

Results released by Kaleido Bio show KB109 is safe and tolerable, with no adverse effects related to the therapy, although the company otherwise gave no specifics. Participants receiving KB109 report 51 percent fewer visits to health care facilities, such as urgent care centers or hospitals, than participants using self-supported care alone. Among participants with one or more underlying health conditions, the rate is 62 percent lower for KB109 recipients. In addition, participants with one or more underlying health conditions resolve their Covid-19 symptoms in a median of 21 days, compared to 30 days for participants using self-support care alone.

“Despite historic progress in advancing Covid-19 vaccinations, new strains of the virus continue to emerge, necessitating safe, orally available therapies for patients around the world,” says Kaleido Bio president Dan Menichella in a company statement. Menichella adds, “Because KB109 is designed to affect the host’s immune response, rather than the virus itself, we believe it may produce a similar response to virus variants or other types of viral respiratory infections.”

The company is enrolling participants in two more clinical trials, to better understand the physiological effects of KB109 in patients with Covid-19 infections, and as a treatment for long-haulers, patients with long-term effects from Covid-19.

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