FDA clears IND application for cell therapy to treat end-stage liver disease

The FDA cleared an investigational new drug utility for LYG-LIV0001, an allogeneic hepatocyte transplantation resolution for end-stage liver illness, in response to the agent’s producer.

LYG-LIV0001 (LyGenesis) is a regenerative mobile remedy comprising allogeneic hepatocytes suspended in a buffered cell preservation resolution which are transplanted into periduodenal lymph nodes. The novel remedy allows a affected person’s lymph nodes “for use as bioreactors to regrow functioning ectopic organs,” in response to the producer.

The IND clearance will permit LyGenesis to start a first-in-human, section 2a dose-escalation research to look at the protection, tolerability and efficacy of the remedy. The research will enroll adults with end-stage liver disease who’re ineligible for a liver transplant.

The proof-of-concept research goals to verify the minimal dose of transplanted hepatocytes to soundly obtain sufficient allogeneic hepatocyte engraftment in periduodenal lymph nodes. It additionally will consider efficacy of the remedy by utilizing liver operate panels to evaluate the flexibility of hepatocyte transplants to switch liver operate.

“The FDA clearance for our IND and the beginning of our section 2a research in sufferers with [end-stage liver disease] is a sworn statement to our sturdy preclinical analysis program, the unmet want in advanced liver disease, and our novel strategy to organ regeneration,” Michael Hufford, PhD, co-founder and CEO of LyGenesis, mentioned in company-issued press launch. “Furthermore, the dearth of genetic manipulation, ease of administration and low price of products for our cell remedy varieties the muse for a promising and scalable first business product.”