TAIPEI, Taiwan, Oct. 24, 2018, /PRNewswire/ — TaiwanJ Pharmaceuticals, a specialty pharmaceutical company dedicated to the development and commercialization of small molecules for unmet medical needs, recently announced the results of phase II clinical trial of JKB-122 for the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) that demonstrated significant improvement on relevant diagnosis and biomarkers from the JKB-122 treated subjects after the completion of 12-week study.
JKB-122 is a small molecule and a long-acting TLR4 antagonist showing anti-fibrotic, immuno-modulating, and anti-inflammatory effects for the treatments of chronic liver diseases including Non-Alcoholic Fatty Liver Disease (NAFLD), Autoimmune Hepatitis (AIH), and Non-Alcoholic Steatohepatitis (NASH).
A total of 121 subjects in Taiwan participated in a phase 2, randomized, multiple-dose, double-blind, placebo-controlled study of JKB-122 for the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD), focusing on both drug efficacy and safety. All subjects were divided into 3 testing groups, respectively receiving once daily 5 mg, 35 mg JKB-122, and placebo during the study. The entire testing period lasts 12 weeks.
According to the unblinded results, the phase 2 study has successfully achieved its primary endpoint with the statistical significance (P<0.05) in efficacy. In 35 mg JKB-122 treated group, there were 36.9% of subjects showing statistically significant reduction by over 30% or recovering to normal value in alanine aminotransferase (ALT) with reduction of liver fat content monitored by Magnetic Resonance Spectroscopy (MRS); mean change of ALT, -18.3 IU, P=0.0067. In addition, the secondary endpoints of the trial were achieved, with 70% of subjects showing statistically significant reduction by over 30% in aspartate aminotransferase (AST); mean change of AST, -8.2 IU, P=0.0235. The whole group showed statistically significant reduction with triglyceride (TG) recovered to normal; mean change of TG, -26.0 IU, P=0.0225. There were 33% of subjects showing liver fat content (by MRS) reduced over 30%; liver fat content (by MRS) showed statistically significant reduction; mean change of liver fat content, -4.2 IU, P=0.0005. High-density lipoproteins (HDL) showed statistically significant increase; mean change of HDL, +2.7 IU, P=0.0084. Tissue inhibitor of metalloproteinase 1 (TIMP-1) showed statistically significant reduction; mean change of TIMP-1, -37.8 IU, P=0.0391. Moreover, the drug JKB-122 is safe and well-tolerated in this study.
For JKB-122, TaiwanJ Pharmaceuticals is planning to file the phase III clinical study application to TFDA in Q2, 2019.
NAFLD is the most common chronic liver disease. Statistics have shown that the prevalence rate of NAFLD is around 25% worldwide, 24% in Europe, and 27% in Asia. Most importantly, NAFLD is the initial stage of a serial subsequent liver diseases of Non-Alcoholic Steatohepatitis (NASH), cirrhosis, and hepatocellular carcinoma. In addition, there are no effective treatments for these liver diseases. According to the analytical reports of TechNavio, Deutsche Bank, and ITRI’s IEK, the NAFLD/NSAH drug market is expected to be US$ 3.9 billion by 2020, and reach to US$ 38.2 billion with 23% CAGR by 2030.
About TaiwanJ Pharmaceuticals
TaiwanJ Pharmaceuticals Co., Ltd is a specialty pharmaceutical company dedicated to the development and commercialization of small molecules for unmet medical needs such as NAFLD/NASH, chronic organ inflammation of metabolic, autoimmune and infectious etiologies. In addition, immune modulating therapies for cancers are being pursued.
For additional information on TaiwanJ, please visit the Company’s website at www.taiwanj.com for English http://www.taiwanj.com/pages/page_index_en, where you can review the Company’s SEC filings, press releases, announcements and events.
Various statements in this release concerning TaiwanJ’s future expectations constitute "forward-looking statements" within the meaning of the Taiwan Securities and Exchange Act. These statements include words such as "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of TaiwanJ to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Some of these risks are: changes in relationships with collaborators; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. In addition, any forward-looking statements represent TaiwanJ’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. TaiwanJ does not assume any obligation to update any forward-looking statements unless required by law.
TaiwanJ Pharmaceuticals Co., Ltd.
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