In this episode of Raising Biotech, host Surani dives into the high-stakes story of Arialys Therapeutics, a biotech startup with a bold mission: to revive ART5803, a neuropsychiatric drug that had been left for dead by Astellas. Armed with $58 million in seed funding, Arialys is pushing this drug forward as a treatment for anti-NMDA receptor encephalitis (ANRE), a rare and devastating autoimmune condition with symptoms straight out of Brain on Fire, the memoir-turned-film that brought this disorder into the public eye. Joining Surani are CEO and co-founder Jay Lichter, along with clinical heavyweights Marty Jepson, Chair of Arialys’s Clinical Advisory Board, and Dr. Leon Henderson McLennan, Medical Advisor and co-founder of InThought Research, to break down the strategy, science, and vision behind the company.
Lichter reveals that Arialys wasn’t just any startup—it was built with a laser focus. A group of venture capitalists set their sights on ART5803, determined to give it a second shot. By pulling expertise from Astellas into the team, Arialys restructured the drug’s development strategy, broadening its potential beyond encephalitis to tackle autoimmune psychosis, a condition where the immune system wages war on brain cells, causing severe neurological damage.
The science behind ART5803 zeroes in on modulating NMDA receptors, crucial players in the brain’s immune response. Jepson underscores the limitations of current treatments, which often blanket the immune system with suppressants that bring harsh side effects. In contrast, ART5803’s targeted approach could fast-track relief while minimizing the risks. Dr. Henderson McLennan dives into the preclinical work with marmosets, where the drug showed rapid, promising effects. While the results are compelling, he doesn’t sugarcoat the reality: transitioning from animal models to human trials in complex CNS disorders is fraught with challenges.
Looking ahead, Lichter lays out Arialys’s clinical game plan: trials in healthy volunteers are set for 2024, with patient trials for ANRE on the horizon in 2025. The FDA’s orphan disease designation gives the company some regulatory leverage, but Lichter is clear—more funding will be needed to navigate the tricky terrain of clinical development. Beyond targeting encephalitis, Arialys is eyeing broader applications for ART5803, like schizophrenia, which could open doors to a much larger market.
As for the long-term vision, Lichter pulls no punches: while Arialys could stay independent and focus on niche markets, the real endgame is an acquisition. Aligning with a larger pharmaceutical company could provide the muscle needed to fully scale and capitalize on the drug’s potential.
Intrigued by how Arialys Therapeutics plans to bring back a shelved drug and make it a game-changer for severe neuropsychiatric conditions? Tune into the full episode of Raising Biotech for exclusive insights from Jay Lichter, Marty Jepson, and Dr. Leon Henderson McLennan.
[This episode was aired on 12 December 2023]