Biostax Corp Announces FDA Acceptance of Three Investigational New Drug Applications Transfers for JKB-122 for the Treatment of NASH, NAFLD, and AIH
Immune Therapeutics, Inc. d/b/a Biostax Corp. recently announced it has accepted the transfer of three Investigational New Drug Applications (IND) for the drug candidate, JKB-122, and the US 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.
JKB-122 is a small molecule and a long-acting TLR4 antagonist that has been shown to play a prominent role in the pathogenesis of certain autoimmune and inflammatory conditions including the treatments of chronic liver diseases such as Non-Alcoholic Fatty Liver Disease (NAFLD), Autoimmune Hepatitis (AIH), and Non-Alcoholic Steatohepatitis (NASH).
“As we continue to build out and diversify our development pipeline, which has a focus on immunology and nephrology, we are excited to complete this milestone,” said Kelly Wilson, President of Biostax. “This transaction is transformational for Biostax as it allows us to support a balanced pipeline and advance innovative therapeutic solutions that help people living with autoimmune diseases and chronic illness.”
Biostax Corp. is a pioneering pharmaceutical company involved in the acquisition, development, and commercialization of pharmaceutical and biotechnology products that have a well-defined path to market. By utilizing a biotech portfolio hub-and-spoke engine, we plan to advance focused and efficient small-scale biotechnology and pharmaceutical programs through subsidiaries, investment vehicles or partnerships, and deploy products from those programs in markets both in the US and internationally for initial commercialization.
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