Furestem-AD (hUCB-MSCs) / Kangstem Biotech - LARVOL DELTA

Kang Stem Biotech, application for approval of change in clinical trial plan [Google translation] (HIT News) - "The company applied for approval of change in the 1/2a clinical trial plan for repeated administration of FURESTEM-AD Inj. to the Ministry of Food and Drug Safety. The purpose is to evaluate the safety and efficacy of repeated administration of FURESTEM-AD Inj. to patients with moderate to severe chronic atopic dermatitis."

Clinical protocol • Atopic Dermatitis

Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis (clinicaltrials.gov) - P1/2; N=96; Recruiting; Sponsor: Kang Stem Biotech Co., Ltd.; Enrolling by invitation ➔ Recruiting

Clinical • Enrollment status • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • CCL27 • IL17A • IL22 • SERPINB4

Kangstem Biotech secures 39 billion won in funds 'green light'… Clinical speed 'UP' [Google translation] (docdocdoc.co.kr) - "Kang Stem Biotech, which is about to make an offering for public offering on the 18th, has received an active response from existing investors, and a green light has been put on raising funds through capital increase....Kangstem Biotech plans to invest KRW 20.8 billion for PureStem-AD, KRW 7 billion for PureStem-RA, and KRW 9.9 billion for PureStem-OA....Kangstem Biotech is working on the second phase 3 clinical trial (FURIN) of PureStem-AD, a treatment for atopic dermatitis, which was approved by the Ministry of Food and Drug Safety in May."

Financing • New P3 trial • Atopic Dermatitis • Immunology • Osteoarthritis

smart(FURIN): Safety and Efficacy of FURESTEM-AD Inj. for Moderate to Severe Atopic Dermatitis (AD) (clinicaltrials.gov) - P3; N=308; Recruiting; Sponsor: Kang Stem Biotech Co., Ltd.

New P3 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Evalution the Safety and Efficacy in Atopic Dermatitis Patients (clinicaltrials.gov) - P=N/A; N=98; Active, not recruiting; Sponsor: Kang Stem Biotech Co., Ltd.; Recruiting ➔ Active, not recruiting; N=194 ➔ 98

Enrollment change • Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Long-term Follow-up Study to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj (clinicaltrials.gov) - P; N=102; Not yet recruiting; Sponsor: Kang Stem Biotech Co., Ltd.

Clinical • New trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis (clinicaltrials.gov) - P1/2; N=96; Enrolling by invitation; Sponsor: Kang Stem Biotech Co., Ltd.

Clinical • New P1/2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • CCL27 • IL17A • SERPINB4

Safety and Efficacy of FURESTEM-AD Inj. in Patients With Moderately Subacute and Chronic Atopic Dermatitis (AD) (clinicaltrials.gov) - P1/2; N=30; Completed; Sponsor: Kang Stem Biotech Co., Ltd.; Active, not recruiting ➔ Completed

Trial completion • Biosimilar • Dermatitis • Eczema • Immunology • Inflammation

Safety and Efficacy of FURESTEM-AD Inj. in Patients With Moderate to Severe Chronic Atopic Dermatitis(AD) (clinicaltrials.gov) - P3; N=197; Completed; Sponsor: Kang Stem Biotech Co., Ltd.; Recruiting ➔ Completed

Clinical • Trial completion

Safety and Efficacy of FURESTEM-AD Inj. in Patients With Moderate to Severe Chronic Atopic Dermatitis(AD) (clinicaltrials.gov) - P3; N=194; Recruiting; Sponsor: Kang Stem Biotech Co., Ltd.; Phase classification: P2b ➔ P3; Initiation date: Dec 2016 ➔ Feb 2018; Trial primary completion date: Dec 2017 ➔ Mar 2019; Trial completion date: Jun 2018 ➔ Jun 2019

Clinical • Phase classification • Trial completion date • Trial initiation date • Trial primary completion date

Safety and Efficacy of FURESTEM-AD Inj. in Patients With Moderate to Severe Chronic Atopic Dermatitis(AD) (clinicaltrials.gov) - P3; N=194; Recruiting; Sponsor: Kang Stem Biotech Co., Ltd.; Initiation date: Feb 2018 ➔ Mar 2018

Clinical • Trial initiation date

KangStem Biotech fails in phase-3 study on atopic dermatitis drug (Korea Biomedical Review) - P3, N=197; NCT03269773; Sponsor: Kang Stem Biotech Co., Ltd; “KangStem Biotech said it has failed to prove the efficacy of Furestem-AD…for atopic dermatitis, in a local phase-3 clinical trial. The biotech firm said Thursday it could not secure statistical significance in the evaluation of Eczema Area and Severity Index-50 (EASI-50), the primary endpoint result, in the phase-3 study on 197 patients…in comparison to the placebo group."

P3 data