Genflow Biosciences PLC (LSE:GENF, OTCQB:GENFF) has reported progress across its two main research programmes, as the company moves closer to starting human trials for its gene therapies aimed at tackling age-related conditions.
The London-listed group said it is continuing to prepare GF-1002, its lead candidate, for clinical trial authorisation in Europe.
This sign-off is a necessary regulatory step that allows companies to start testing new medicines in people.
Genflow is working with its manufacturing partner, Exothera, to ensure that production meets good manufacturing practice standards, a set of regulations that govern how medicines must be made to guarantee quality and safety.
At the same time, key efficacy studies are underway with independent contract research partners Physiogenex and Accelera, which are testing the drug’s effects in both early and advanced forms of MASH, a liver disease known as metabolic dysfunction-associated steatohepatitis.
For its second programme, GF-1004, Genflow has submitted an amendment to the protocol for an ongoing proof-of-concept clinical trial in older dogs.
The revised plan specifies the dose rate when the investigational gene therapy is given intravenously, which the company said should help maintain patient safety by reducing the risk of side effects during infusion.
The trial, which started in March with research partner Syngene, is intended to assess whether Genflow’s gene therapy can address age-related decline in dogs.
GF-1004 uses a version of the SIRT6 gene found in people who have lived to a very old age.
Genflow’s chief executive, Dr Eric Leire, said: "This update reflects the growing maturity of our pipeline and our continued commitment to advancing science-backed therapies in healthy ageing.
"The combination of expected non-dilutive funding, strategic partnerships, and supportive regulatory tailwinds puts Genflow in a strong position to accelerate both our programs."
The company, which is the only listed longevity-focused business in Europe, expects its latest activities to support regulatory submissions and the start of further clinical studies.