Candidate: KB109

Type: Glycan developed using Kaleido’s Microbiome Metabolic Therapy (MMT) platform.

2021 Status: Kaleido said March 23 that it intended to file an IND application with the FDA for KB109 after generating positive results in a non-IND study (NCT04414124) in patients with mild-to-moderate COVID-19. According to the company, an analysis from the full dataset showed a reduction in overall COVID-19 related healthcare use—defined as including hospitalizations, emergency room visits, and urgent care visits—by approximately 62% among patients with one or more comorbidity and by approximately 51%overall.

The non-IND study also showed 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, compared to patients receiving self-supportive care alone. 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. And 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, Kaleido added.

The multi-center, open label, controlled clinical study enrolled 350 patients, of which 181 received KB109 plus self-supportive care and 169 received self-supportive care alone.

On January 14, Kaleido reported positive interim results from the K031 non-IND controlled clinical study assessing outpatients with mild to moderate COVID-19 disease in a planned interim analysis comprising about half of the total study population (n=176). Median time to resolution of 13 overall COVID-19 related symptoms for patients with one or more comorbidity at baseline was 18 days for patients treated with KB109 plus supportive self care, compared with 27 days with SSC alone.

The analysis also showed that KB109 was well tolerated, with a safety profile consistent with previous studies of MMT candidates and no unexpected treatment-related adverse events.

Topline data from the full study population of 350 patients, and results of second study of KB109, are expected later in the first quarter.

2020 Status: Kaleido said October 6 that topline data from the multi-center K031 clinical study (NCT04414124) of approximately 350 patients designed to assess KB109 added to Supportive Self-Care (SSC) for outpatients with mild-to-moderate COVID-19 will be delayed until the first quarter of 2021. The company offered no reason for the delay, but said it was unexpected. Previously, Kaleido projected that topline data would be available in the fourth quarter of 2020.

Also expected in the first quarter of 2021, as previously projected, will be data from a controlled 50-participant clinical study (K032; NCT04486482) designed to assess KB109 added to SSC for outpatients with mild-to-moderate COVID-19. The K032 study was launched with Massachusetts General Hospital in July. Patients have been randomized (1:1) to either receive SSC or SSC plus KB109 for two weeks, then followed for three weeks. Patients will be evaluated for safety, physiologic effects, and gut microbiota structure and function, Kaleido said.

“Our clinical program will evaluate the effects of KB109 in mitigating inappropriate inflammatory response to COVID-19, and potentially avoiding more serious complications,” stated Katharine Knobil, M.D., Kaleido’s Chief Medical Officer and Head of Research & Development.

COVID-19: 300 Candidates and Counting

To navigate through the >300 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:

FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.

DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.

KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.

TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.

GEN has also tagged the most common treatment types: