Kaleido, COPD Foundation Partner to Investigate KB109

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by Vanda Pinto PhD |

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Kaleido Biosciences is teaming up with the COPD Foundation to investigate KB109, a small compound designed to modulate the gut microbiome — the community of microbes living in the intestines — as a potential treatment for chronic obstructive pulmonary disease (COPD).

The decision was based on promising findings from a previous trial showing that people with mild-to-moderate COVID-19 and additional comorbidities (other medical conditions) taking KB109 recovered faster and had lower rates of medically attended visits than those receiving only self-supportive care (SSC).

In collaboration with the COPD Foundation’s COPD360Net, Kaleido now plans to test KB109 for the treatment of COPD in a Phase 2a clinical trial to be launched in early 2022.

“We are excited to embark on this partnership with the COPD Foundation to work towards our shared mission to bring about innovative therapies for people suffering from COPD,” Dan Menichella, Kaleido’s president and CEO, said in a press release.

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“The previous KB109 COVID-19 trial demonstrated activity against the pathologies [diseases] associated with respiratory viral infections by modulating the gut microbiome and host immune system. We believe this result warrants clinical investigation of KB109 in COPD patients, and we look forward to initiating a Phase 2a trial early in 2022,” Menichella added.

KB109 is a microbiome metabolic therapy (MMT), a type of treatment that works by changing the function and distribution of the microbiome’s bacteria to decrease or increase the production of certain metabolites — the intermediate products that originate from metabolic reactions.

KB109 increases the production of short-chain fatty acids, which have been reported to affect the body’s immune response in respiratory infections caused by viruses. These metabolites, also were found to promote the growth of commensal, or non-harmful, bacteria and to reduce the number of disease-causing microbes.

According to the company, these findings suggest that short-chain fatty acids may help curb the body’s exaggerated immune response against SARS-CoV-2, the virus that causes COVID-19, and prevent more serious complications.

Kaleido recently completed a clinical trial (NCT04414124) designed to investigate the safety of KB109, as well as its effects on COVID-19-related symptoms, in 350 patients who tested positive for SARS-CoV-2. Patients received KB109 combined with SSC, or SSC alone, for two weeks and were followed for an additional three weeks.

Findings showed that KB109 was well-tolerated and able to lower the number of hospitalizations, emergency room visits, and urgent care visits by approximately 51%. In patients with one or more comorbidity, medically attended visits dropped by 62%. The therapy also reduced the median recovery time by 10 days in patients who had one or more comorbidity, or in those who were 45 and older.

COPD patients who experience severe acute exacerbations, in which breathing becomes increasingly difficult, frequently need to be hospitalized. In most cases, these exacerbations are thought to be triggered by viral or bacterial infections in the respiratory tract. This leads to dysbiosis, or harmful alterations in the composition of the lung microbiome, inflammation, and immune dysregulation.

Kaleido and the COPD Foundation believe KB109 may be able to correct dysbiosis in people with COPD, and therefore help avoid exacerbations and symptom worsening caused by respiratory infections.

“At the Foundation, we were excited when we saw the KB109 COVID-19 data because of its potential to improve recovery from viral infections for patients with comorbidities”, said Ruth Tal-Singer, PhD, the COPD Foundation’s president and CEO.

“The COPD burden is projected to increase in the coming decades because of continued exposure to risk factors and the aging population. COPD patients would benefit from an oral therapy that could reduce exacerbations and improve quality of life. We are proud to partner with Kaleido in our continued efforts to find a treatment intervention that is affordable and potentially more efficacious for patients,” Tal-Singer added.