CAMBRIDGE, Mass.--(BUSINESS WIRE)--LG Chem Life Sciences Innovation Center announced today that results from the Company’s Phase I study of LC51-0255 in healthy volunteers were recently shared during DDW 2020, May 2-5. The ePoster highlighted the safety, pharmacokinetics and mechanistic properties of LC51-0255.
LC51-0255, the sphingosine-1-phosphate receptor 1 (S1P1) modulator in development as a new therapeutic class for the treatment of ulcerative colitis, was well-tolerated in healthy subjects using once-daily oral administration for up to 21 days. Subjects were randomized to either placebo, 0.25mg, 0.5mg, 1mg, 1.5mg or 2mg. Systemic exposure and absolute lymphocyte count (ALC) reduction proved dose-proportional, with favorable pharmacokinetic profile.
“We are delighted to be moving LC51-0255 into Phase II this year,” said Adam Benson, Director of Clinical Development at LG Chem Life Sciences Innovation Center. “There still remains a significant unmet need for a well-tolerated oral therapy in ulcerative colitis. Given it continues to hit our efficacy and safety goals, we feel LC51-0255 will make significant impact in the armamentarium against ulcerative colitis.”
LC51-0225 is a potent, selective, and orally available S1P1 modulator, believed to functionally inhibit S1P activity and subsequently reducing the number of circulating lymphocytes, trapping them in the lymph nodes. The decrease in circulating lymphocytes is intended to reduce the immune response driving symptomatic ulcerative colitis.
A Phase II trial in patients with moderate to severely active ulcerative colitis is currently in development.
Details of the poster are as follows:
Meeting: Digestive Disease Week (DDW) 2020
Title: Safety, pharmacokinetics and immune modulatory properties of LC51-0255, an oral, selective sphingosine 1-phosphate 1 (S1P1) receptor modulator, in healthy volunteers
Poster Number: Tu1881
Presentation Type: ePoster
Lead Author: Inyoung Hwang, MD
Date Available: Saturday May 2, 2020 at 9:30am
About Ulcerative Colitis
Ulcerative colitis (UC) is a chronic disease of unknown etiology that is characterized by inflammation of the rectum and colon. Symptoms include diarrhea, rectal bleeding (RB), urgency, and tenesmus. Ulcerative colitis has a relapsing-remitting course, which means that many patients have intermittent disease flares that are interspersed with periods of remission. Existing standard of care agents for UC primarily work by treating the acute symptoms of UC, inducing remission in the majority of cases, with approximately 60% to 70% of patients achieving remission with first-line corticosteroid therapy. Of those who receive second-line therapy such as biologics, about 30% to 40% of patients do not respond to treatment despite optimal therapy, while another 23% to 46% of patients lose response over time or discontinue treatment, resulting in limited clinical benefits.
About Spingosine-1-Phosphate Receptor 1 (S1P1) Modulators
LC51-0255, a sphingosine-1-phosphate receptor 1 (S1P1) modulator, is part of a new class of drugs being developed for the treatment of UC. S1P signal transduction through the S1P1 receptors plays an important role in a series of responses, including inflammation and repair processes, which are related to UC, Crohn’s disease, and other inflammatory diseases. S1P agonism, in particular to ulcerative colitis, is thought to reduce the number of circulating lymphocytes, and thus dampening the pathological immune response.
About LG Chem Life Sciences Innovation Center (https://innovation.lgchem.com): The LG Chem Life Sciences brand has been established since the 1980s. Owned by LG Chem, a subsidiary of the global LG group, the LG Chem Life Sciences Innovation Center explores local collaborations to transform lives by inspiring science & leading innovation, partnering with academia and industry for therapeutic development excellence. The LG Chem Life Sciences Innovation Center is currently focused on building a pipeline in Autoimmune, Immuno-Oncology and Metabolic diseases. As an extension of LG Chem Life Sciences in Seoul, South Korea, the Innovation Center is backed by the full value chain of a pharmaceutical company. It will continue to build new partnerships, support early development, and create new alliances across the Cambridge ecosystem.