KBL697 / KoBioLabs - LARVOL DELTA

A Study to Investigate Efficacy and Safety of KBL697 in Patients with Moderate Plaque Type Psoriasis (clinicaltrials.gov) - P2 | N=80 | Completed | Sponsor: KoBioLabs | Active, not recruiting ➔ Completed | Trial completion date: Mar 2024 ➔ Oct 2024

Trial completion • Trial completion date • Dermatology • Immunology • Psoriasis

Lactobacillus gasseri KBL697 ameliorates psoriatic inflammation through the modulation of gut-skin axis (IMMUNOLOGY 2024) - "Oral administration of KBL697 showed a significant beneficial effect in imiquimod-induced mouse models, judged by the skin inflammation, PASI score and immune profile change. In the skin analysis, key cytokines in psoriasis, such as IL-17A, IL-23, and IL-36, are downregulated while genes for skin regeneration are upregulated, supporting the model for KBL697 working in the gut-skin axis. Therefore, KBL697 has great potential as a novel therapeutic agent for the treatment of psoriasis."

Dermatitis • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Psoriasis • IFNG • IL10 • IL17A • IL23A • IL6

A Study to Investigate Efficacy and Safety of KBL697 in Patients With Mild to Moderate Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: KoBioLabs | N=30 ➔ 0 | Trial completion date: Dec 2023 ➔ Jul 2023 | Recruiting ➔ Withdrawn | Trial primary completion date: Nov 2023 ➔ Jul 2023

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

A Study to Investigate Efficacy and Safety of KBL697 in Patients With Moderate Plaque Type Psoriasis (clinicaltrials.gov) - P2 | N=80 | Active, not recruiting | Sponsor: KoBioLabs | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2023 ➔ Mar 2024 | Trial primary completion date: Apr 2023 ➔ Nov 2023

Enrollment closed • Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis

KoBioLabs suspends P2a trial of ulcerative colitis drug (Korea Biomedical Review) - "KoBioLabs has suspended the phase 2a clinical trial of its ulcerative colitis (UC) drug candidate KBL697 (pipeline name: KBLP-007). KoBioLabs said...that it had voluntarily withdrawn its phase 2a clinical trial of KBL697. In July 2021, KoBioLab received approval for its phase 2a investigational new drug (IND) trial from the U.S. Food and Drug Administration. This past April, the company received approval for its phase 2a IND from the Ministry of Food and Drug Safety....The trial suspension will inevitably delay the commercialization of the drug pipeline."

Trial suspension • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Study to Investigate Efficacy and Safety of KBL697 in Patients With Mild to Moderate Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: KoBioLabs | Trial completion date: Sep 2022 ➔ Dec 2023 | Trial primary completion date: Aug 2022 ➔ Nov 2023

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

A Study to Investigate Efficacy and Safety of KBL697 in Patients With Moderate Plaque Type Psoriasis (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: KoBioLabs | Trial completion date: Jan 2023 ➔ Apr 2023 | Trial primary completion date: Oct 2022 ➔ Apr 2023

Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis

Co-administration of Lactobacillus gasseri KBL697 and tumor necrosis factor-alpha inhibitor infliximab improves colitis in mice. (PubMed, Sci Rep) - "Related changes in the predicted amino and nucleic acid metabolic pathways were also evident, along with increased acetate and butyrate level. Therefore, the synergistic effect of L. gasseri KBL697 and IFX co-administration is a possible method of prevention and treatment for IBD."

Journal • Preclinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Oncology • CD4 • FOXP3 • IFNG • IL10 • IL17A • IL2RA • IL6

A Study to Investigate Efficacy and Safety of KBL697 in Patients With Mild to Moderate Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: KoBioLabs | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • CRP

A Study to Investigate Efficacy and Safety of KBL697 in Patients With Moderate Plaque Type Psoriasis (clinicaltrials.gov) - P2; N=80; Recruiting; Sponsor: KoBioLabs; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Dermatology • Immunology • Psoriasis

KoBioLabs, exporting 120 billion won worth of technology for immune disease treatment materials to China [Google translation] (MBN) - "KoBioLabs...exports about 100 million won technology to SPH SINE, a subsidiary of Shanghai Pharma, China, which is an immune disease treatment material, 'KBL697' and 'KBL693'. It was announced on the 28th that it had signed a contract worth 7 million dollars (about 125.3 billion won). KoBioLabs will receive a down payment of $2.5 million (about KRW 2.9 billion) with no obligation to return, and milestones for each stage of clinical development, approval, and commercialization sequentially. Royalty is separate, and the contract term is 20 years after product release. Shin-Yi has secured the rights to develop and commercialize KBL697 and KBL693 in China, Hong Kong, Macao and Taiwan. The rights to other regions are reserved by KoBioLabs."

Licensing / partnership • Asthma • Atopic Dermatitis • Dermatology • Inflammatory Bowel Disease • Psoriasis • Respiratory Diseases • Ulcerative Colitis

KoBioLab, FDA approval of phase 2 clinical trial for ulcerative colitis [Google translation] (Maekyung Media Group) - "KoBioLab said that the U.S. Food and Drug Administration (FDA) has approved the Phase 2a clinical trial plan for KBLP-007 (candidate KBL697), a new drug candidate for the microbiome (microbiome) being developed as a treatment for ulcerative colitis...KoBiolab plans to pre-treat antibiotics to patients with mild to moderate ulcerative colitis at 8 institutions in Australia and then administer KBL697 to evaluate the efficacy and safety."

New P2a trial • Inflammatory Bowel Disease • Ulcerative Colitis

KoBioLab, development of treatment for immune diseases is cruising… Subsequent pipelines are also ’solid’ [Google translation] (Economic Review) - "'KBLP-007' is a pipeline under development targeting ulcerative colitis, one of inflammatory bowel diseases (IBD), based on the same strain and formulation as KBLP-001. Previously, it confirmed superior safety compared to placebo in the global phase 1 clinical trial, and applied for an IND in the US phase 2 clinical trial earlier this month. If the IND is passed, we aim to start dosing in clinical trials within the year."

New P2 trial • Inflammatory Bowel Disease • Ulcerative Colitis

GoBioLab, development of treatment for immune diseases is cruising…Subsequent pipelines are also 'solid' [Google translation] (Economic Review) - "Currently, a human application test to determine its effectiveness is in progress in Korea. The atopic patient completed medication in May. Asthma patients are in the interim analysis stage. The results are expected to be confirmed in July and August of this year. In the second half of the year, it plans to submit a phase 2 IND to the FDA as an indication with better efficacy."

Clinical data • IND • Atopic Dermatitis • Dermatology

A Study to Investigate Efficacy and Safety of KBL697 in Patients With Mild to Moderate Active Ulcerative Colitis (clinicaltrials.gov) - P2; N=30; Not yet recruiting; Sponsor: KoBioLabs; Trial completion date: Sep 2021 ➔ Sep 2022

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

GoBioLab submits KBLP-007 phase 2 clinical trial plan to FDA [Google translation] (Newspim) - "GoBio Labs announced...that it has submitted a US clinical 2a clinical trial plan for the immune disease pipeline 'KBLP-007' to the US Food and Drug Administration (FDA). If the clinical trial plan is passed, it aims to start dosing for clinical trials within the year...In this 2a clinical trial, antibiotics are pre-administered to patients with mild to moderate ulcerative colitis and KBL697, a new drug candidate, will be administered for 8 weeks, and then efficacy and safety will be evaluated...If this clinical trial is approved, GoBioLab's two immune disease pipelines will enter phase 2 clinical trials in the US."

FDA event • New P2a trial • Inflammatory Bowel Disease • Ulcerative Colitis

A Study to Investigate Efficacy and Safety of KBL697 in Patients With Moderate Plaque Type Psoriasis (clinicaltrials.gov) - P2; N=80; Not yet recruiting; Sponsor: KoBioLabs

Clinical • New P2 trial • Dermatology • Immunology • Psoriasis

A Study to Investigate Efficacy and Safety of KBL697 in Patients With Mild to Moderate Active Ulcerative Colitis (clinicaltrials.gov) - P2; N=30; Not yet recruiting; Sponsor: KoBioLabs

Clinical • New P2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • CRP

A Study of Single and Multiple Ascending Doses of KBL697 in Healthy Subjects (clinicaltrials.gov) - P1; N=36; Completed; Sponsor: KoBioLabs; Active, not recruiting ➔ Completed

Clinical • Trial completion

A Study of Single and Multiple Ascending Doses of KBL697 in Healthy Subjects (clinicaltrials.gov) - P1; N=36; Active, not recruiting; Sponsor: KoBioLabs; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

A Study of Single and Multiple Ascending Doses of KBL697 in Healthy Subjects (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: KoBioLabs; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open