Genflow Biosciences PLC (LSE:GENF, OTCQB:GENFF) CEO Dr Eric Leire talked with Proactive's Stephen Gunnion about the company’s upcoming clinical trial application in Europe for its MASH (metabolic dysfunction-associated steatohepatitis) therapy, GF-1002.
Leire explained that Genflow is prioritising the European Medicines Agency over the FDA as it seeks clinical trial authorisation (CTA) for its GF-1002 programme. He emphasised the importance of this milestone in building company value, stating: “To have proof of efficacy in humans is super important for us to move as fast as possible to clinical trial authorisation.”
The company is working with Belgian-based CDMO Exothera on the CMC part of the filing, and Leire said results so far have exceeded expectations. He also highlighted the dual-CRO strategy involving Physiogenex and Accelera to address both early and late-stage MASH models. This approach aims to provide flexibility when engaging with regulators about the most effective path forward.
In a second update, Leire said the protocol for Genflow’s GF-1004 dog trial has been amended. The changes relate to the infusion rate of the gene therapy, intended to ensure consistency and future usability by private veterinarians. This is seen as a key step toward a potential partnership with an animal health company, which would bring non-dilutive funding to the business.
Leire also mentioned supportive market tailwinds from upcoming FCA regulatory changes.
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