Genflow Biosciences PLC (LSE:GENF, OTCQB:GENFF), a leader in longevity research, has announced significant advancements in its pre-clinical efforts aimed at combating age-related diseases.
Chief among them was the receipt of guidance from the US Food & Drug Administration INTERACT programme regarding its lead drug candidate, GF-1002, aimed at treating metabolic-associated steatohepatitis (MASH).
The FDA has advised Genflow to proceed with identifying appropriate animal models through pilot proof-of-concept studies. These studies will guide the definitive proof-of-concept, toxicology, and biodistribution studies needed for future clinical trials.
The company has initiated a feasibility study with Exothera S.A, a Contract Development Manufacturing Organization (CDMO), to evaluate the production of its MASH clinical lot under Good Manufacturing Practices (GMP). This step is crucial for ensuring the quality and compliance of its future clinical trials.
Genflow is also in the final stages of selecting Contract Research Organizations (CROs) for an upcoming dog clinical trial of its drug candidate, GF-1004. The company is currently reviewing proposals and aims to finalize agreements next month.
"We are excited by the momentum we have built in moving forward with our pre-clinical programs and the guidance received from the FDA," said Genflow CEO, Dr Eric Leire.
"This encouragement reinforces our commitment to developing effective therapeutic solutions for age-related diseases. As we move forward with our dog clinical trials, we remain focused on our mission to improve healthspan."