Major Milestone: Hepagene Therapeutics Gets Green Light from FDA for HPG7233 THR Beta Agonist’s Investigational New Drug Application (IND)

HONG KONG and NANJING, China, Sept. 20, 2023 /PRNewswire/ — In a groundbreaking development, Hepagene Therapeutics, Inc., a visionary clinical-stage biopharmaceutical powerhouse, proudly announces the FDA’s resounding clearance of its Investigational New Drug (IND) application for HPG7233—a remarkable Thyroid Hormone Receptor beta (THR-β) agonist. This monumental achievement signifies a beacon of hope for patients battling non-alcoholic steatohepatitis (NASH) and dyslipidemia.

HPG7233, a highly selective small molecule THR-β agonist with an affinity for the liver, emerges from preclinical studies as a true game-changer. It dazzles with its exceptional selectivity and potency, orchestrating significant reductions in liver triglycerides and serum LDL-C within relevant animal models. But the real magic happens when HPG7233 joins forces, unveiling a remarkable synergy—especially when paired with HPG1860 (Hepagene’s internal Phase II FXR agonist). The safety and tolerability of HPG7233, as evidenced in toxicology studies, reaffirm its potential to revolutionize NASH treatment.

Dr. Michael X. Xu, the visionary President and CEO of Hepagene, expressed his delight at this momentous achievement: “We are delighted that FDA has cleared the IND application for HPG7233, which expands our NASH pipeline and represents another important milestone for Hepagene.” The company is gearing up to kickstart the HPG7233 clinical study, with great anticipation for its successful implementation.

Dr. Xu further shared, “To improve the modest efficacy observed with first-generation NASH candidates, we will also actively explore combo studies of THR-β agonist with internal FXR and/or GLP-1R agonist.” With its superior preclinical profile, HPG7233 stands as a beacon of hope—a potential game-changer for patients grappling with NASH and dyslipidemia.

About HPG7233

In the intricate world of thyroid hormone receptors, THR-β takes center stage within the liver’s grand theater. This crucial player, when activated, wields the power to orchestrate a symphony of benefits—reducing liver fat and orchestrating a melodious improvement in dyslipidemia. Enter HPG7233, a novel marvel meticulously crafted to target the liver, armed with the title of being a highly selective small molecule thyroid hormone receptor beta (THR-β) agonist.

HPG7233 doesn’t just play the part; it excels in it. Picture high selectivity and potency that rival the virtuosos of our time. Add to that an uncanny affinity for the liver—a true liver enthusiast. In both rodent and non-rodent animals, HPG7233 flaunts a profile that makes the liver its canvas, painting strokes of significant reductions in liver triglycerides and serum LDL-C.

It doesn’t stop there—HPG7233’s remarkable performance extends to NASH models, where it commands a significant reduction in NAS scores, paving the way for healthier liver journeys and combating dyslipidemia with unparalleled finesse.

About Hepagene Therapeutics, Inc.

In the relentless battle against life-threatening conditions, one biopharmaceutical company stands tall – Hepagene Therapeutics, Inc. With a laser-focused mission, they devote their boundless energy to uncovering, nurturing, and delivering groundbreaking medicines that illuminate the path to triumph for patients grappling with a formidable array of foes.

These include the relentless adversaries known as non-alcoholic steatohepatitis (NASH), the persistent scourge of chronic Hepatitis B infection (HBV), the insidious specter of liver cancer, and the daunting challenge of advanced solid tumors.

In the grand arena of healthcare, Hepagene Therapeutics emerges as a beacon of hope and a driving force, relentlessly pushing the boundaries of what is possible to bring solace and healing to those in need.

Their commitment extends beyond innovation; it’s a lifeline extended to patients on their journey towards recovery and resilience. In the realm of liver health, Hepagene Therapeutics is more than a company; it’s a dedicated ally, working tirelessly to script stories of survival and transformation.

Leave a Comment