zectivimod (LR19019) / LG Chem, TransThera Biosci - LARVOL DELTA

Dose-dependent reduction of lymphocyte count and heart rate after multiple administration of LC51-0255, a novel sphingosine-1-phosphate receptor 1 modulator, in healthy subjects. (PubMed, Front Pharmacol) - " Daily administration of LC51-0255 in the range of 0.25-2 mg resulted in a dose-dependent reduction of lymphocyte counts and heart rate. LC51-0255 is generally safe and well tolerated in healthy volunteers."

Clinical • Journal • Atrial Fibrillation • Cardiovascular • Immunology

Single-dose of LC51-0255, a Selective S1P Receptor Modulator, Showed Dose-dependent and Reversible Reduction of Absolute Lymphocyte Count in Humans. (PubMed, Clin Transl Sci) - "LC51-0255 was well tolerated up to 2 mg, and the most common TEAE was bradycardia. The results of this study suggest that LC51-0255 can be developed into a beneficial treatment option for autoimmune disease."

Clinical • Journal • Cardiovascular • Immunology • Ophthalmology

LG Chem enters P2 trial of autoimmune disease treatment candidate in China (Korea Biomedical Review) - "LG Chem said that Transthera Bioscience, its Chinese partner, has received approval from the Chinese National Medical Products Administration (NMPA) to conduct a phase 2 clinical trial into LC510255, an autoimmune disease treatment candidate. LG Chem will receive an undisclosed milestone from Transthera, which will recruit Chinese ulcerative colitis patients to evaluate the efficacy and safety of the drug."

New P2 trial • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy and Safety of LC51-0255 in Subjects With Ulcerative Colitis (clinicaltrials.gov) - P2; N=0; Withdrawn; Sponsor: LG Chem; N=240 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Ministry of Food and Drug Safety approves 9 clinical trials including bladder urothelial cell cancer anticancer drug [Google translation] (Health Korea News) - "LG Chem received approval for phase 2 clinical trial of 'LC51-0255'. To evaluate the clinical efficacy and safety of 'LC51-0255' in 95 patients with moderate to severe atopic dermatitis....Withers Pharm will conduct a bioequivalence test comparing and evaluating its 'Astin Tablet' (azelastine hydrochloride) and the original drug, 'Bugwang Azeptin Tablet' (azelastine hydrochloride) of Bukwang Pharmaceutical. 'Bugwang Azeptin Tablet' is an antihistamine that is effective for bronchial asthma, allergic rhinitis, urticaria, eczema, and dermatitis. Withers Pharma's bioaviability test will be conducted on 40 subjects at DTC R.O. and Seokgyeong Central Hospital."

New P2 trial • New trial • Atopic Dermatitis • Respiratory Diseases

LG Chem signs strategic partnership contract with China’s TransThera on new drugs (Pulse) - "LG Chem has entered a strategic partnership with China’s TransThera Biosciences, allowing the clinical-stage biotech company to develop and commercialize LC510255, a drug candidate for autoimmune diseases, across China...Under the contract, TransThera will hold exclusive rights to develop and commercialize LC510255 in China, while LG Chem in other markets around the world."

Licensing / partnership • Immunology • Inflammatory Bowel Disease

Compare the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of LC51-0255 Film-coated Tablet (SG85) With LC51-0255 Uncoated Tablet (SG82) in Healthy Subjects (clinicaltrials.gov) - P1; N=18; Completed; Sponsor: LG Chem; Not yet recruiting ➔ Completed; Trial completion date: Mar 2021 ➔ Dec 2020

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

A Study To Evaluate The Safety, Pharmacokinetics/Pharmacodynamics (PK/PD) and Food Effect Of LC51-0255 (clinicaltrials.gov) - P1; N=100; Completed; Sponsor: LG Chem; Recruiting ➔ Completed

Clinical • Trial completion

LG Chem Life Sciences Innovation Center announces data from phase I study of its ulcerative colitis treatment LC51-0255 (Businesswire) - "P1,N=110; NCT03174613; Sponsor: LG Chem; Positive topline results of oral LC51-0255 presented at virtual Digestive Disease Week (DDW) 2020 as ePoster...was well-tolerated in healthy subjects using once-daily oral administration for up to 21 days....We are delighted to be moving LC51-0255 into Phase II this year."

New P2 trial • P1 data • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

SAFETY, PHARMACOKINETICS AND IMMUNE MODULATORY PROPERTIES OF LC51-0255, AN ORAL, SELECTIVE SPHINGOSINE 1-PHOSPHATE 1 (S1P1) RECEPTOR MODULATOR, IN HEALTHY VOLUNTEERS (DDW 2020) - "LC51-0255 was well tolerated in healthy subjects when administered once daily for 21 days at dose levels ranging from 0.25mg to 2mg. Systemic exposure was dose-proportional and PK profile was favorable for once daily regimen. ALC displayed a dose-dependent reduction."

Clinical • PK/PD data • Cardiovascular • Gastroenterology • Immune Modulation • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Compare the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of LC51-0255 Film-coated Tablet (SG85) With LC51-0255 Uncoated Tablet (SG82) in Healthy Subjects (clinicaltrials.gov) - P1; N=18; Not yet recruiting; Sponsor: LG Chem

Clinical • New P1 trial • Gastroenterology • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis