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HepaStem, BIV201, and Albutein are late-stage pipeline agents in development for NASH, focusing specifically on decompensated cirrhosis.
The development of effective treatments for the management of nonalcoholic steatohepatitis (NASH) has captivated the medical community in recent years.
However, among the 33 late-stage pipeline items in development for NASH, just 3 focus on decompensated cirrhosis due to NASH: HepaStem, BIV201, and Albutein.1
“Notably, as the NASH market continues to see approvals for agents focusing on cirrhosis improvement and liver regeneration that are indicated for patients in the earlier stages of NASH, the need for a treatment option for DC due to NASH will decrease as fewer patients develop DC. Until that point is reached, it remains to be seen whether or not HepaStem, BIV201, and Albutein will perform and gain approval,” said Sravani Meka, senior immunology analyst at GlobalData.1
“ACLF is a severe, life threatening disease, with no current available treatments. The only option for patients is organ transplant, which is a major procedure and often not accessible. HepaStem has the potential to be the first real alternative to liver transplants in such a disease, and help ACLF patients in need,” said John Tchelingerian, PhD, president and chief executive officer of the Promethera Group.2
“Compelling data from the first 15 patients led us to pause enrollment,” commented Cuong Do, president and CEO of BioVie.3 “Given the high unmet need for this condition, we believe the most prudent course is to initiate conversations with the FDA on proceeding to the pivotal Phase 3 trial so that we can bring this innovation to patients as quickly as possible.”
“There is great potential for albumin to improve the survival prospects of patients suffering from decompensated cirrhosis until they can get a liver transplant, a large unmet need given the limited availability of livers for patients,” said Sandra Camprubi, senior director of clinical operations for Grifols.4