Genflow Biosciences PLC (LSE:GENF, OTC:GENFF) said it has received encouraging advice from Belgium's Federal Agency for Medicines and Health Products (FAHMP) which will allow it to start first in human trials on its drug candidate, GF-1002.
The trials will focus on patients with Non-Alcoholic Steatohepatitis (NASH), a liver disease that can lead to cirrhosis or liver cancer, rather than healthy volunteers.
Usually, the protocol is to begin with subjects with no underlying issues to allow researchers to assess how the putative treatment interacts with the body and assess for potential side effects.
The FAHMP green light comes after the company showed promising results in both lab-grown human cells and animal studies.
Genflow plans to start its NASH clinical trials in about 18 months, following further discussions and an agreement with the European Medicine Agency.
Chief executive Eric Leire said: "We are thrilled that the FAHMP has recommended Genflow to commence phase I/II clinical trials in NASH patients rather than with healthy volunteers.
"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 programme in conducting our proposed clinical trial in humans."
In the same announcement, the group also said it had completed a debt restructuring that ensures it is compliant with existing grants and means it is eligible for future financial support.