Neuraly announced it has raised $36 million to advance its lead candidate NLY01 into clinical testing as a potential disease-modifying agent for Parkinson’s disease, and to develop other investigative compounds for this and similar neurodegenerative disorders.
The company, a Johns Hopkins University startup, expects to start a clinical trial of NLY01 this year.
“Currently, there aren’t any treatments that reverse, stop, or even slow neurodegeneration in diseases like Parkinson’s and Alzheimer’s. The treatments that do exist – all symptomatic – provide only temporary improvement in motor and cognitive function, but even these become less effective over time,” Seulki Lee, PhD, chairman, founder, and CEO of Neuraly, said in a press release. “We believe that the science supports NLY01 as a potential disease-modifying therapy capable of slowing the progression of disease.”
NLY01, developed by researchers at Johns Hopkins School of Medicine, binds to a specific type of receptors called glucagon-like peptide-1 receptors (GLP-1R), which are found on pancreas cells.
The receptor is best known for its role in insulin signaling, and has been studied as a means to treat diabetes type 2. But studies also suggest that GLP-1 mimicking compounds — which activate GLP-1R — can penetrate into the brain, where they seem to exert neuroprotective functions.
In preclinical studies in mice models of Parkinson’s, NLY01 was seen to prevent nerve cell damage by binding to microglia cells, which are involved in immune responses to infection or injury in the brain. In Parkinson’s patients, microglia cells are often overactive, damaging nerve cells.
Because similar drugs are already approved to treat diabetes — such as Byetta (exenatide) and Victoza (liraglutide) — researchers expect that further work will show NLY01 has a similar and well-tolerated safety profile.
With the $36 million raised in a Series A financing round, Neuraly is planning to soon begin a Phase 1 trial of NLY01, and to add other neuroprotective candidates to its treatment pipeline.
“We expect NLY01 to be a pioneering treatment for Parkinson’s with low development risks as we have seen unprecedented efficacy in pre-clinical models and well-characterized safety profiles in a similar class of molecules,” said Viktor Roschke, PhD, chief scientific officer of Neuraly. “We look forward to initiating NLY01 into clinical trials later this year.”
As part of the funding agreement, John Ku, executive vice president of Smilegate Investment; Phillip Jung, associate at Maryland Venture Fund; Junghee Lim, executive managing director of InterVest; and Keele Park, CEO of Magna Investment, will join Lee and Roschke on Neuraly’s board of directors.