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Biostax Corp Granted FDA Approval to Transfer Three Investigational New Drug Applications (INDs) for JKB-122 Targeting Treatment of NASH, NAFLD, and AIH

Wednesday, August 16, 2023

Biostax Corp, operating under Immune Therapeutics, Inc. (OTC Pink: IMUN), a biotech development entity, has announced the successful acceptance and finalization of the transfer of three Investigational New Drug Applications (INDs) for their drug candidate JKB-122 by the U.S. Food and Drug Administration (FDA). These transferred INDs include IND 146955, aimed at addressing nonalcoholic steatohepatitis (NASH) and fibrosis; IND 147347, targeting Nonalcoholic Liver Disease (NAFLD); and IND 127303, designed for the treatment of Autoimmune Hepatitis, which has also obtained the Orphan Designation for Autoimmune Hepatitis. The ownership of these INDs was transferred from TaiwanJ Pharmaceuticals to Biostax Corp in 2022, as part of the license agreement for the development and commercialization of JKB-122.

JKB-122 is a small molecule functioning as a prolonged TLR4 antagonist, exhibiting significant potential in combating certain autoimmune and inflammatory conditions, particularly chronic liver ailments like Non-Alcoholic Fatty Liver Disease (NAFLD), Autoimmune Hepatitis (AIH), and Non-Alcoholic Steatohepatitis (NASH).

Kelly Wilson, the President of Biostax, expressed enthusiasm over achieving this crucial milestone, emphasizing the company's dedication to expanding their development portfolio in the fields of immunology and nephrology. Wilson remarked that this transaction holds transformative significance for Biostax, enabling them to foster a balanced development pipeline and propel innovative therapeutic solutions for individuals dealing with autoimmune disorders and persistent health conditions.

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