Genflow makes progress towards clinical trial of NASH gene therapy

Company hopes to commence European trial of SIRT6-boosting gene therapy in 18 months.

Gene therapy company Genflow Biosciences has received positive feedback from Belgium’s Federal Agency for Medicines and Health Products as it seeks to move into human clinical trials.  Genflow is developing gene therapies that target the aging process, with a focus on reducing and delaying age-related diseases.

Genflow’s approach involves the use of adeno-associated virus (AAV) vectors to deliver copies of the Sirtuin-6 (SIRT6) gene variant found in centenarians into cells. Sirtuins are a group of proteins that play a vital role in regulating various cellular processes. In recent years, SIRT6 has gained attention for its potential role in promoting healthy aging.

Genflow says it has received written advice from the FAHMP to commence clinical trials of its lead compound (GF-1002) in patients suffering from NASH, an aggressive form of non-alcoholic fatty liver disease, rather than in healthy volunteers.  While further discussions and agreement with the European Medicine Agency (EMA) are still required, Genflow says that it expects a NASH clinical trial to commence in approximately 18 months.

NASH affects approximately 35 million individuals worldwide and is a leading cause of chronic liver disease and liver transplants. Genflow’s GF-1002 drug aims to reverse fibrotic liver damage, restoring it to normal functionality.

“We are thrilled that the FAHMP has recommended Genflow to commence Phase I/II clinical trials in NASH patients rather than with healthy volunteers,” said Eric Leire, CEO of Genflow. “We hope that this will provide a first signal of efficacy in humans more speedily. We will continue to seek guidance and recommendations from the FAHMP to develop an appropriate program in conducting our proposed clinical trial in humans.”

The FAHMP’s recommendation to proceed with clinical trials in NASH patients comes after what Genflow describes as “promising results” obtained from the company’s studies in human cells and rodents.

“We are hopeful that these trials will showcase the ability of longevity gene-therapy assisting patients with life-limiting illnesses,” added Leire. “The current financial outlook for the Company remains positive as it is in a secure financial position. Genflow Biosciences has sufficient cash reserves until March 2025 and continues to seek further non-dilutive funding in the form of research grants.”

Disclosure: First Longevity Ltd which operates this website (Longevity.Technology) has a commercial interest in Genflow Biosciences Ltd.