TaiwanJ Pharmaceuticals unveiled first-stage unblinding of Phase II clinical trials in chronic liver disease (CLD) due to HCV infection

TaiwanJ Pharmaceuticals is a discovery-based drug company focused on research and development of novel ‘antiinflammatory and immunomodulating’ agents with blockbuster potential.  Its short-term goal is to develop products through 505(b)(2) regulatory pathway, followed by gradually building up a line of novel drugs.  Two repurposed drugs have been tested in clinical trials since 2015.  Four clinical studies on chronic liver disease due to different causes are ongoing in order to ascertain treatment efficacy and help set the direction of drug commercialization, present clinical evidence of the drugs’ efficacy to lower risks, and steer TaiwanJ toward a more favorable position for licensing negotiations.   Current antiviral agents for HCV all act through viral eradication only; no drugs are yet available that could manage chronic hepatitis and fibrosis resulting from the infection.  In order to address this unmet medical need, TaiwanJ initiated the Phase II trial of HCV CLD and is planning to further develop new indications of the JKB-122.  The first-stage data of the HCV CLD Phase II study is now completed.  An Advisory Committee meeting took place on August 30th, 2017.  On the basis of trend analysis and overall consideration, the optimal dosage for JKB-122 was identified at 15 mg, which achieved anticipated efficacy at the first stage.  In the patients receiving 5 mg and 15 mg JKB-122, there were no tolerability and safety issues.  Other indications under development for JKB-122 include ‘NAFLD’ and ‘AIH’; both drug trials is ending enrollment.  Development of other related indications for JKB-122 is under discussion.

Notwithstanding, the HCV patient population needed for clinical studies happens to fall into those covered by the Health Insurance starting 2017.  As a result, there is long delay in ending the enrollment due to difficulties in recruiting new patients.  Moreover, the market for anti-HCV agents has significantly shrunk.  Following benefit analysis and recommendations by the expert panel, TaiwanJ has decided not to move forward to Phase III for testing HCV CLR indication.  While the entire Phase II study was not able to complete and achieve statistical significance (P<0.05) in efficacy, the study results clearly demonstrated a strong trend that JKB-122 improved liver function and was safe.  The results will form the basis for safe use of JKB-122 in the treatment of NASH and AIH and facilitate study design in future trials.

The unblinding of ‘JKB-121 for NASH’ Phase II study results by TaiwanJ will occur in the 4th Qtr of the current year.  In addition, two JKB-122 clinical trials are still ongoing, which are for NAFLD and AIH and scheduled to complete in the first half of 2018.

TaiwanJ established a team of experienced medicinal chemists in late 2016 to work on NCEs, following a strategy often used by major pharmas worldwide.  It leverages the discovery team’s knowledge of drug patentability and experience in structural design, synthesis, process development, and pharmacology to target known lead drugs in specific therapeutic areas as paradigms and generate novel compounds with intellectual property and rapidly yield a highly competitive line of products.  At the present stage, TaiwanJ has developed a new generation of TLR4 antagonists and other small molecules against relevant molecular targets for the NASH therapy.  The IND is expected to be filed within two years.  Concurrently novel inhibitors of IL-4 and IL-13 for the treatment of asthma and atopic dermatitis are being explored.