naltrexone (JKB-122) / TaiwanJ, Biostax Corp - LARVOL DELTA

Biostax Corp. Signs Collaboration Agreement with Immgenuity, Inc. to Pursue Remission in HIV (GlobeNewswire) - "Immune Therapeutics...announces the signing of a research collaboration agreement with Immgenuity, Inc. The joint research will focus on using Immgenuity’s IMTV014 and Biostax’s Lodonal™ and JKB-122 both independently and together to determine if the immune modulatory effects of Biostax’s drug therapies combined with Immgenuity’s IMTV014 can achieve remission with HIV patients. Under the terms of the agreement, Immgenuity and Biostax will collaborate to advance the development of novel immunotherapies for the treatment of HIV and other diseases."

Licensing / partnership • Human Immunodeficiency Virus

Biostax Corp Announces the FDAs Acceptance of Three Investigational New Drug Applications (IND) Transfers for JKB-122 for the Treatment of NASH, NAFLD and AIH (GlobeNewswire) - "Immune Therapeutics...announces that they have accepted the transfer of three Investigational New Drug Applications (IND) for the drug candidate, JKB-122 and the U.S. Food and Drug Administration (FDA) has finalized those transfers. The INDs that were transferred to Biostax include IND 146955 for the treatment of nonalcoholic steatohepatitis (NASH) and fibrosis, IND 147347 for the treatment of Nonalcoholic Liver Disease (NAFLD) and IND 127303 for the treatment of Autoimmune Hepatitis along with the Orphan Designation for Autoimmune Hepatitis. These INDs were transferred from TaiwanJ Pharmaceuticals, who licensed the development and commercialization of JKB-122 to Biostax Corp in 2022."

IND • Autoimmune Hepatitis • Immunology • Metabolic Disorders • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis

Effect of JKB-122 on Prednisolone and Azathioprine Induced Remission in Autoimmune Hepatitis (AIH) (clinicaltrials.gov) - P2; N=120; Not yet recruiting; Sponsor: TaiwanJ Pharmaceuticals Co., Ltd; Phase classification: P2/3 ➔ P2; N=210 ➔ 120; Initiation date: Jul 2020 ➔ Nov 2020; Trial primary completion date: Jul 2023 ➔ Nov 2023

Clinical • Enrollment change • Phase classification • Trial initiation date • Trial primary completion date • Hepatology • Immunology

[VIRTUAL] JKB-122 in subjects with non-alcoholic fatty liver disease (NAFLD): a phase 2, randomized, multiple-dose, double-blind, placebo-controlled study (EASL-ILC-I 2020) - "JKB-122 35 mg improves NAFLD in primary efficacy endpoint and some secondary efficacy endpoints, such as ALT, liver fat content in MRS image, cCK-18 level and Enhanced Liver Fibrosis (ELF) score, although no significant inter-group difference was observed compared to placebo. In term of safety profile, JKB-122 was well-tolerated."

Clinical • Late-breaking abstract • P2 data • Fibrosis • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Immunology • Liver Cirrhosis • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis • Oncology • Solid Tumor • Transplantation • TLR4

A Pharmacokinetic Study of JKB-122 Tablets Compared to Capsule (clinicaltrials.gov) - P1; N=8; Not yet recruiting; Sponsor: TaiwanJ Pharmaceuticals Co., Ltd; Trial completion date: Aug 2020 ➔ Dec 2020; Initiation date: Apr 2020 ➔ Aug 2020; Trial primary completion date: Jul 2020 ➔ Dec 2020

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Immunology

TaiwanJ Pharmaceuticals announces positive top-line results from phase 2 study of JKB-122 on non-alcoholic fatty liver disease (NAFLD) (PRNewswire) - P2, N=121; "TaiwanJ Pharmaceuticals...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...For JKB-122, TaiwanJ Pharmaceuticals is planning to file the phase III clinical study application to TFDA in Q2, 2019."

New P3 trial • P2 data • Metabolic Disorders • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis

Effect of JKB-122 on Prednisolone and Azathioprine Induced Remission in Autoimmune Hepatitis (AIH) (clinicaltrials.gov) - P2/3; N=210; Not yet recruiting; Sponsor: TaiwanJ Pharmaceuticals Co., Ltd

Clinical • New P2/3 trial • Immunology

A Pharmacokinetic Study of JKB-122 Tablets Compared to Capsule (clinicaltrials.gov) - P1; N=8; Not yet recruiting; Sponsor: TaiwanJ Pharmaceuticals Co., Ltd

Clinical • New P1 trial

A Study to Evaluate the Efficacy and Safety of JKB-122 in Patients With NASH and Fibrosis (clinicaltrials.gov) - P2; N=300; Not yet recruiting; Sponsor: TaiwanJ Pharmaceuticals Co., Ltd; Phase classification: P3 ➔ P2

Clinical • Phase classification

A Study to Evaluate the Efficacy and Safety of JKB-122 in Patients With NASH and Fibrosis (clinicaltrials.gov) - P3; N=300; Not yet recruiting; Sponsor: TaiwanJ Pharmaceuticals Co., Ltd

Clinical • New P3 trial

JKB-122AIH: Liver Test Study of Using JKB-122 in AIH Patients (clinicaltrials.gov) - P2; N=20; Completed; Sponsor: TaiwanJ Pharmaceuticals Co., Ltd; Active, not recruiting ➔ Completed

Trial completion

Jingkai hepatitis medicine step [Google Translate] (money.udn.com) - “The second-stage clinical trial for the treatment of non-alcoholic steatohepatitis (NAFLD) indications reached the standard, and it is expected that the clinical phase III trial will be submitted to TFDA in the second quarter of this year.”

New P3 trial