University of Ulsan

WEDNESDAY, March 19, 2025 -- For patients with chronic liver disease , statin use is associated with a reduced risk for hepatocellular carcinoma (HCC) and hepatic decompensation, according to a study published online March 17 in JAMA Internal Medicine . Jonggi Choi, M.D., Ph.D., from the University of Ulsan College of Medicine in Seoul, South Korea, and colleagues used data from the Research Patient Data Registry from 2000 to 2023 for patients aged 40 years or older with chronic liver disease and a baseline Fibrosis-4 (FIB-4) score of 1.3 or higher to examine the association between statin use and the risk for HCC and hepatic decompensation. The analysis included 16,501 participants: 3,610 statin users and 12,891 nonusers. The researchers found that compared with nonusers, statin users had a significantly lower 10-year cumulative incidence of HCC (3.8 versus 8.0 percent) and hepatic decompensation (10.6 versus 19.5 percent). The adjusted subhazard ratios were 0.67 and 0.78 for HCC and hepatic decompensation, respectively. Further reductions in HCC and hepatic decompensation risks were seen in association with exposure to lipophilic statins and duration of statin use (≥600 cumulative defined daily dose). Among 7,038 patients with serial FIB-4 data with intermediate baseline FIB-4 scores, 14.7 percent of statin users and 20.0 percent of nonusers transitioned to the high group. For patients with high baseline FIB-4 scores, 31.8 and 7.0 percent of statin users transitioned to the intermediate-risk and low-risk groups, respectively, compared with 18.8 and 4.3 percent of nonusers. "These findings underscore the potential of statins as chemopreventive agents against HCC through their role in mitigating fibrosis progression," the authors write. One author disclosed ties to Gilead Sciences Research.

PANGYO, South Korea, Feb. 23, 2024 /PRNewswire/ -- Oscotec Inc. and ADEL Inc. announced the dosing of the first healthy participant in its first-in-human study of ADEL-Y01 for the treatment of Alzheimer's disease (AD). Oscotec and ADEL are jointly developing a novel disease-modifying immunotherapy agent (ADEL-Y01) targeting tau protein accumulation in the AD brain. ADEL-Y01 is uniquely designed to target tau protein acetylated at lysine-280 (acK280), inhibiting aggregation and propagation of toxic tau and thus may slow the course of the disease. This phase 1a/1b study in the U.S. is to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of ADEL-Y01 in 40 healthy volunteers as well as in 33 participants with Mild Cognitive Impairment due to Alzheimer's disease or mild Alzheimer's disease. "Given that tau is strongly correlated with AD progression and clinical severity, targeting of tau is anticipated to effectively slow the disease progress. As our understanding of the pivotal role of the tau mid-region MTBR increases, selecting the right epitope becomes crucial in developing tau-targeting therapeutics to attain clinical benefits", explained SeungYong Yoon, MD/PhD, CEO of ADEL. "Oscotec is pleased to reach a significant milestone leading the clinical study as a co-developer with ADEL, and we will continue to bring innovative medicines in neurogenerative diseases", said Taeyoung Yoon, CEO of Oscotec. The preclinical results of ADEL-Y01 in animal models were published last year, demonstrating improvement in memory impairment, behavioral deficits through the inhibition of Tau seeding and propagation.("Monoclonal antibody Y01 prevents tauopathy progression induced by lysine 280–acetylated tau in cell and mouse models" in The Journal of Clinical Investigation 2023) About Oscotec Inc. Oscotec is a clinical stage drug discovery and development company pursuing translation of rigorous science into innovative medicine for clinically unmet needs.. The Company's clinical pipeline consists of targeted therapeutics in immunology and oncology. Oscotec is developing cevidoplenib (SYK inhibitor) for ITP (Phase 2, completed) and FLT3/AXL inhibitor for AML (Phase 1) as well as solid tumors (Phase 1). The company is also the originator of Lazertinib (LECLAZA®), a 3rd generation EGFR inhibitor being developed by Janssen Pharma and Yuhan Corp. for lung cancers. About ADEL Inc. ADEL is a leading company of cutting-edge technologies for the treatment and diagnosis of neurological diseases including Alzheimer's disease. Founded by scientists who have investigated Alzheimer's disease at Asan Medical Center, University of Ulsan College of Medicine, Korea, ADEL is developing smart, innovative drug candidates for the patients worldwide. Contacts Jihyun Park, IR/PR [email protected] Kyung Hoon Hwang, Research Director/COO [email protected] SOURCE Oscotec Inc.

PANGYO, South Korea, Sept. 14, 2023 /PRNewswire/ -- Oscotec Inc. and ADEL Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application of ADEL-Y01 for the treatment of Alzheimer's disease (AD). Oscotec and ADEL are jointly developing a novel disease-modifying immunotherapy agent (ADEL-Y01) targeting tau protein accumulation in the AD brain. ADEL-Y01 is a recombinant IgG1 class type monoclonal humanized antibody that recognizes and binds to tau protein acetylated at lysine-280 (acK280) thus inhibiting aggregation and propagation of tau seeds and enhancing microglial tau clearance. Administration of ADEL-Y01 has ameliorated memory impairment, behavioral deficits, and tau pathology in preclinical models, which was published early this year ("Monoclonal antibody Y01 prevents tauopathy progression induced by lysine 280-acetylated tau in cell and mouse models" in The Journal of Clinical Investigation) This phase 1a/1b study is to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of ADEL-Y01 in healthy volunteers as well as in participants with Mild Cognitive Impairment due to Alzheimer's disease or mild Alzheimer's disease. "We are convinced that ADEL-Y01 has the strong potential to be a much needed treatment option for patients with Alzheimer's disease based on its novel mechanism of action and the strength of preclinical data," said Dr. Taeyoung Yoon, CEO/CSO of Oscotec. "Initiating the first-in-human study of ADEL-Y01 is a significant milestone to the Oscotec-Adel partnership, which also serves as a vehicle for Oscotec in expanding its R&D horizon beyond small molecule." "The IND clearance by the FDA represents a major achievement for us, especially in light of our first candidate entering into clinical trials," said Seung-Yong Yoon, M.D., CEO of ADEL. "We are enthusiastic about commencing the clinical trial, as it brings us closer to providing therapeutic solutions for the patients grappling with tauopathies including AD." About Oscotec Inc. Oscotec is a clinical stage drug discovery and development company pursuing translation of rigorous science into innovative medicine for clinically unmet needs.. The Company's clinical pipeline consists of targeted therapeutics in immunology and oncology. Oscotec is developing cevidoplenib (SYK inhibitor) for ITP (Phase 2, completed) and FLT3/AXL inhibitor for AML (Phase 1) as well as solid tumors (Phase 1). The company is also the originator of Lazertinib (LECLAZA®), a 3rd generation EGFR inhibitor being developed by Janssen Pharma and Yuhan Corp. for lung cancers. About ADEL Inc. ADEL is a leading company of cutting-edge technologies for the treatment and diagnosis of neurological diseases including Alzheimer's disease. Founded by scientists who have investigated Alzheimer's disease at Asan Medical Center, University of Ulsan College of Medicine, Korea, ADEL is developing smart, innovative drug candidates for the patients worldwide. Contacts Jihyun Park, IR/PR [email protected] June Hahn, BD [email protected] Kyung Hoon Hwang, Research Director/COO [email protected] SOURCE Oscotec Inc.