TaiwanJ Pharmaceuticals Announces Positive Results from Phase 2 Orphan Drug Designation Study of JKB-122 on Autoimmune Hepatitis (AIH)
HSINCHU, Taiwan, Jan. 21, 2019 /PRNewswire/ --
TaiwanJ Pharmaceuticals, a specialty pharmaceutical company dedicated to the development and commercialization of small molecules for unmet medical needs such as NASH and Cancers, recently announced the results of phase II clinical trial of JKB-122 for the treatment of refractory Autoimmune Hepatitis (AIH) patients that demonstrated improvement on targeted objectives and relevant biomarkers from the JKB-122 treated subjects after the completion of 24-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 20 subjects in US participated in the phase 2, escalating dose, open study of JKB-122 for the treatment of Autoimmune Hepatitis (AIH) with inadequate response to current treatment, focusing on both drug efficacy and safety. All subjects received once daily 5 mg increased monthly up to 40 mg JKB-122 if the subject's ALT performance was not improved during the study. The entire testing period lasts 24 weeks, 80% of the patients completed the study. A responder is defined as a more than 50% decrease from Baseline or a decrease to normal range ALT levels. At the 24th week, there were 31% responders in the complete population.
According to the trial results, the phase 2 study has successfully achieved its primary endpoint with the statistical significance (P<0.05) in efficacy compare to the baseline in the responder group; mean change of ALT is -70.0 IU (80.6%), P=0.004. In addition, the secondary endpoints of the trial were achieved with the mean change of AST -32.8 IU (67.2%), P=0.022; the mean change of GGT -77.0 IU (66.8%), P=0.033; the mean change of ALP -17.8 IU (29.4 %). Moreover, the drug JKB-122 is safe and well-tolerated in this study. As an orphan drug designation, the study result of JKB-122 provides a further opportunity for the AIH treatment.
For JKB-122, TaiwanJ Pharmaceuticals is carrying out further process to file the phase II/III clinical study application on AIH to FDA in Q2, 2019.
AIH is an immune modulated chronic liver disease with unknown etiology and no effective therapeutic agents for it. Current treatment of AIH relies only on corticosteroid and immune suppressors that give rise to serious side effects. Most importantly, AIH is the initial stage of a serial subsequent liver diseases including cirrhosis and hepatocellular carcinoma. As such, there is an urgent need to develop a drug for AIH. According to the analytical reports of TechNavio and ITRI's IEK, the AIH drug market is expected to be US$ 251.7 Million by 2015, and reach to US$ 700 Million with 22.7% CAGR by 2022.
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.