Getting JUV-161 to Phase I in 2025

In this Pharmaceutical Executive video interview, Hanadie Yousef, PhD, co-founder and CEO of Juvena Therapeutics, and 2023 Pharmaceutical Executive Emerging Pharma Leader, discusses Juvena’s fusion protein JUV-161, which enhances muscle regeneration and metabolism by AKT signaling. JUV-161 targets myotonic dystrophy type one and other muscle-wasting diseases. Juvena is also developing JUV-112 for obesity, targeting adipose tissue without appetite suppression and muscle loss. She also addressed how their platform uses quantitative proteomics and artificial intelligence to identify and validate proteins for therapeutic use.

Pharmaceutical Executive: The timeline indicates Phase I studies for JUV-161 in 2025. What are the key milestones Juvena needs to achieve in the preclinical and IND-enabling stages to ensure this timeline is met?

Hanadie Yousef: I have great news actually on that on that front. We do have a press release coming, but I can just share the good news for now. We actually got an A-track approval, and we're set to be completing our first-in-human dosing next month, so we're on track. We have completed the IND package, and what's coming next in terms of continuing to build our data package as we're getting into Phase I [single ascending dose (SAD)] study is then a longer talk study in primates.

We'll continue doing toxicology to be ready for past the [multiple ascending dose (MAD)] studies, to do a multi month treatment, exploratory trial. That's what's coming, starting Phase I SAD, getting into the MAD study, and then getting into a couple exploratory Phase Ib/Phase IIa studies with longer term treatment, so that we could really begin proving this unique mechanism of action, the potential efficacy, the promise, and the hypothesis behind why we believe this is a pipeline or product; what I like to call the insulin of muscle, in terms of what this is going to be able to do.

It is going to be subcutaneous treatment, so ideally, we're leaning towards getting it towards a pre-filled syringe, where people who are taking JUV-161 will be able to do it just like insulin, right at home. But rather than it be daily injections, like most insulin treatments for diabetes these days, we're aiming towards weekly injections based on the drug properties and its current half-life in primates. We'll see if that pans out in people.