Genflow Biosciences PLC (LSE:GENF, OTCQB:GENFF) CEO Dr Eric Leire talked with Proactive about the company’s upcoming clinical trial application in Europe for its MASH 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.
Proactive: Eric, very good to speak with you. You're preparing for clinical trial authorisation in Europe for GF-1002. How close are you to that milestone and what are the next steps?
Dr Eric Leire: Yes, you're right Stephen. We put our priority on the European Medicines Agency rather than the FDA. The filing for clinical trial authorisation—this CTA—is a huge step in our MASH programme. If you want to increase the valuation of a programme, and therefore the company, it's very important to have that data in humans.
We have good data in animal models, but that does not correlate with an increase in valuation. For the street to put a high valuation on the company, we need to have proof of efficacy in humans. So it’s super important for us to move as fast as possible to clinical trial authorisation.
I can say that we're moving with confidence to this filing. We’re building it with a lot of confidence, mostly because the big part of the filing is the CMC—the manufacturing and the control. We’re working with our CDMO, Exothera. We’ve had a long relationship with them. They are local, we are very close, and we’re extremely confident because we had a test already in bioreactor and we had better-than-expected yield.
So this is very safe for us and gives us peace of mind regarding the filing. Also, regarding the filing, we have a different approach. Usually, the second most important part is to have a pivotal study demonstrating efficacy in animal models, and you do that with an independent CRO. We are doing it with two CROs.
It’s not because we want to waste money, but because MASH is an evolving disease and the entry point is very important. There's more and more interest in MASH due to the success of GLP-1. A lot of people now in pharma and biotech are interested in metabolic disease. MASH is a metabolic disease of the liver and very attractive because there’s no real therapy.
So we face some competition, which is very good and healthy. Having a programme with Physiogenex for early-stage entry and with Accelera for late-stage entry gives us the opportunity to discuss with the European Agency what will be the best strategy. Late-stage is a smaller market but has less competition and higher pricing. Early-stage has a larger market but more competition and more difficulty onboarding patients. We will have this discussion with the European Agency soon, and I hope it will be interesting for us.
Proactive: Eric, also in today's update you've announced that you've amended the protocol for your GF-1004 dog trial. What's the thinking behind that change and what are you hoping to learn from this study?
Dr Eric Leire: Yes, the dog study is ongoing and we made our first amendment to the protocol. It's a very controlled study—randomised and comparative—run by an independent CRO. We’re quite happy with the way it's progressed. We thought it was important to have this first amendment. It’s a little technical—it specifies the rate of infusion, the speed you infuse the gene therapy to the dog.
Why that? It’s very important to have the most consistency in the way the drug is infused. But most importantly, it’s important to give more guidance for the future use by private veterinarians.
We want to have good guidelines so veterinarians will be very comfortable administering the drug. That’s important because it will be a major point for partnership with an animal health company. We’re still looking to have a partnership once we finish the study, which would bring in non-dilutive funding—good news for investors.
Proactive: Eric, I hope you'll keep us posted on progress with both of those programmes. Thank you very much for the update today.