KB295 / Kaleido Biosci - LARVOL DELTA

KB295, A SYNTHETIC GLYCAN, AUGMENTS GUT MICROBIOME COMPOSITION AND FUNCTION IN ULCERATIVE COLITIS: UPDATED RESULTS FROM A PROOF OF PRINCIPAL HUMAN STUDY (DDW 2022) - "Escherichia coli adhesion gene fimH was also depleted after KB295 ingestion in 7 of 9 participants in which it was detected.Our Results establish a proof of principle for the glycan modulation of gut microbiome composition and function and provide insight into the potential of this strategy in patients with UC. The safety, tolerability, and encouraging reduction in inflammatory markers with KB295 support a phase 2 study, which is being initiated."

Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Pain • Transplantation • Ulcerative Colitis • ARPP19

The synthetic glycan KB295 optimises microbiome composition and function in ulcerative colitis: Results from a proof of principle human study (ECCO-IBD 2022) - P=N/A | "Conclusion Our results establish a proof of principle for the glycan modulation of gut microbiome composition and function and provide insight into the potential utility of this strategy in patients with UC. The safety and tolerability of KB295, along with evidence of reduced inflammation, support a phase 2 study, which is planned."

Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

THE SYNTHETIC GLYCAN KB295 OPTIMIZES MICROBIOME COMPOSITION AND FUNCTION IN ULCERATIVE COLITIS – RESULTS FROM A PROOF OF PRINCIPLE HUMAN STUDY (CCCongress 2022) - "These results establish a proof of principle for the glycobiological modulation of gut microbiome composition and function and provide insight into the potential utility of this strategy in patients with ulcerative colitis. The safety, tolerability, and encouraging evidence for reduced inflammation with KB295 call for a Phase 2 study, which is planned."

Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Pain • Transplantation • Ulcerative Colitis

A Clinical Study to Assess the Effects of KB295 in Patients With Ulcerative Colitis (UC) on Gut Microbiota Structure and Function (clinicaltrials.gov) - P=N/A; N=12; Completed; Sponsor: Kaleido Biosciences; Active, not recruiting ➔ Completed

Trial completion • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Kaleido Biosciences to Present Updated Data of KB295 In Ulcerative Colitis at the 2022 Crohn’s and Colitis Congress (GlobeNewswire) - "Kaleido Biosciences, Inc...announced that the topline data obtained with KB295, a novel Microbiome Metabolic Therapy (MMT™), in mild-to-moderate ulcerative colitis (UC), will be presented virtually at the 2022 Crohn’s and Colitis Congress....'The data show the direct effect of administering KB295 includes enriching diverse, beneficial commensal microbiota and restoring balanced SCFA production, while depleting harmful pathobionts in order to suppress inflammation and restore gut homeostasis...'"

Preclinical • Inflammatory Bowel Disease • Ulcerative Colitis

Kaleido Biosciences Announces New Clinical and Preclinical Data Supporting Advancement of KB295 to a Phase 2 Clinical Study in Mild-to-Moderate Ulcerative Colitis (GlobeNewswire) - "Kaleido Biosciences, Inc...announced topline data from the non-IND/CTA clinical study evaluating KB295...in mild-to-moderate ulcerative colitis (UC). The primary objective of safety and tolerability was achieved as KB295 was well tolerated and no safety concerns were observed. In the study, subjects receiving KB295 experienced a reduction in three biomarkers, fecal calprotectin (FCP), fecal lactoferrin, and FimH that are known to be associated with UC disease activity...Achieved primary objective of safety and tolerability with KB295 being well tolerated across subjects (n=12) with no product-emergent serious adverse events reported...Ex-vivo data demonstrated community-wide changes and desired modulation of multiple remission-associated taxa...the Company’s plans to initiate a phase 2 study, under an Investigational New Drug (IND) application and Clinical Trial Application (CTA), with KB295 for mild-to-moderate UC patients in the first half of 2022."

Clinical data • New P2 trial • Preclinical • Inflammatory Bowel Disease • Ulcerative Colitis

Kaleido Biosciences to Host Virtual R&D Presentation to Discuss Clinical Data and Pipeline Advancement on October 5, 2021 (Wallstreet.org) - "The agenda will feature an update on the company's corporate strategy, data from the non-IND study evaluating KB295 in mild-to-moderate UC as well as supportive preclinical data, and data supporting the advancement of KB109 into COPD. KB295 and KB109 are novel, orally administered Microbiome Metabolic Therapies (MMT) developed using Kaleido's proprietary synthetic chemistry technology."

Live event

Kaleido Biosciences to Host Virtual R&D Presentation to Discuss Clinical Data and Pipeline Advancement on October 5, 2021 (Yahoo Finance) - "Latest data and clinical development plans for KB295 in ulcerative colitis (UC) to be presented...Kaleido Biosciences, Inc...announced that it will host a virtual R&D Presentation on October 5, 2021, at 8 a.m. ET. The agenda will feature an update on the Company’s corporate strategy, data from the non-IND study evaluating KB295 in mild-to-moderate UC as well as supportive preclinical data, and data supporting the advancement of KB109 into COPD."

Preclinical • Inflammatory Bowel Disease • Ulcerative Colitis

A Clinical Study to Assess the Effects of KB295 in Patients With Ulcerative Colitis (UC) on Gut Microbiota Structure and Function (clinicaltrials.gov) - P=N/A; N=12; Active, not recruiting; Sponsor: Kaleido Biosciences; Recruiting ➔ Active, not recruiting; N=30 ➔ 12; Trial completion date: Apr 2021 ➔ Dec 2021; Trial primary completion date: Jan 2021 ➔ Oct 2021

Clinical • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Kaleido Biosciences Reports Second Quarter 2021 Financial Results (GlobeNewswire) - "Topline data from the non-IND clinical study of KB295 in patients with mild-to-moderate ulcerative colitis (UC) are expected by the end of the third quarter."

Preclinical • Inflammatory Bowel Disease • Ulcerative Colitis

Kaleido Biosciences Reports Fourth Quarter and Full Year 2020 Financial Results (GlobeNewswire) - "Anticipated Near-Term Milestones:...Topline data from a non-IND clinical study of KB295 in patients with mild-to-moderate ulcerative colitis (UC) expected in mid-2021."

Preclinical • Inflammatory Bowel Disease • Ulcerative Colitis

Kaleido Biosciences Announces the Exercise of the Underwriters’ Option to Purchase Additional Shares of Common Stock (GlobeNewswire) - "Kaleido Biosciences, Inc...announced that...the underwriters have fully exercised their option to purchase an additional 787,500 shares of common stock from the Company. The exercise of this option increases the size of the offering to an aggregate of 6,037,500 shares at a price to the public of $11.50 per share...Kaleido intends to use the net proceeds from the offering, in addition to its existing cash resources, to fund its continued research and development activities...the ongoing clinical study of KB295 in patients with mild-to-moderate ulcerative colitis..."

Financing • Inflammatory Bowel Disease • Ulcerative Colitis

Kaleido Biosciences Announces First Patient Dosed in Clinical Study of Microbiome Metabolic Therapy KB295 in Patients with Mild-to-Moderate Ulcerative Colitis (GlobeNewswire) - "Kaleido Biosciences, Inc....today announced that the first patient has been dosed in its clinical study evaluating Microbiome Metabolic Therapy (MMT) candidate KB295 in patients with mild-to-moderate ulcerative colitis (UC)....Top-line safety, tolerability and activity results expected in mid-2021..."

Clinical data • Trial status • Inflammatory Bowel Disease • Ulcerative Colitis

A Clinical Study to Assess the Affects of KB295 in Patients With Ulcerative Colitis (UC) on Gut Microbiota Structure and Function (clinicaltrials.gov) - P=N/A; N=30; Recruiting; Sponsor: Kaleido Biosciences

Clinical • New trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Kaleido Biosciences Reports Second Quarter 2020 Financial Results and Provides Corporate Update (GlobeNewswire) - "Initiating a clinical study in Q3 2020 evaluating KB295 in approximately 30 patients with mild-to-moderate ulcerative colitis (UC). Topline results are expected in mid-2021."

Clinical data • New trial • Inflammatory Bowel Disease • Ulcerative Colitis

Kaleido Biosciences Reports Second Quarter 2020 Financial Results and Provides Corporate Update (GlobeNewswire) - "Initiating a clinical study in Q3 2020 evaluating KB295 in approximately 30 patients with mild-to-moderate ulcerative colitis (UC). Topline results are expected in mid-2021....Topline data from Phase 2 clinical trial (UNLOCKED) of KB195 in patients with UCD inadequately controlled on standard of care in second half 2021."

Clinical data • New trial • P2 data • Inflammatory Bowel Disease • Ulcerative Colitis

Kaleido Biosciences announces proposed public offering of common stock (Yahoo Finance) - "Kaleido Biosciences...today announced that it intends to sell...$30 million of shares of its common stock in an underwritten public offering. Kaleido also intends to grant the underwriters a 30-day option to purchase an additional $4.5 million of shares of its common stock offered in the public offering....Kaleido intends to use the net proceeds from the offering, in addition to its existing cash resources, to fund...the ongoing Phase 2 clinical trial of KB195 in patients with urea cycle disorders, and the planned clinical study of KB295 in patients with mild-to-moderate ulcerative colitis, to fund any other research and development activities..."

Commercial • Inflammatory Bowel Disease • Ulcerative Colitis

Kaleido Biosciences provides corporate update and reports first quarter 2020 financial results (GlobeNewswire, Kaleido Biosciences) - "Initiating a clinical study later this year evaluating a new MMT candidate, KB295, in approximately 30 patients with mild-to-moderate ulcerative colitis (UC). Top-line results are expected in mid-2021."

Clinical data • New trial • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis