Alto Neuroscience announces Phase 1 results for ALTO-101 to treat CIAS

Alto Neuroscience announced positive results from its healthy volunteer Phase 1 study of ALTO-101, a novel PDE4 inhibitor in development for cognitive impairment associated with schizophrenia CIAS. Results from the study demonstrated favorable tolerability and improved pharmacokinetics of ALTO-101 when administered via a transdermal delivery system TDS compared to oral administration. The TDS formulation is being developed in partnership with MEDRx. The drug exposure levels achieved with the transdermal formulation were significantly greater than systemic exposure with oral administration while also reducing typical class-wide adverse events. The Company plans to initiate a proof-of-concept study evaluating ALTO-101 in patients with CIAS in the first half of 2024, with topline data expected in the second half of 2025…The pharmacokinetic curve illustrates stable drug exposure and achievement of the desired plasma concentration with the transdermal formulation as compared to orally administered ALTO-101…”These positive results provide a strong indication that ALTO-101 could become an important therapeutic option for a broad range of indications,” said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience. “Oral PDE4 inhibitors have shown promise as pro-cognitive therapeutics but are associated with burdensome and dose-limiting side effects…Under the terms of the development agreement between Alto and MEDRx, upon this achievement of the desired pharmacokinetic profile for ALTO-101, MEDRx is eligible to receive a milestone payment of $1.5 M from Alto that is payable in a combination of cash and common stock of Alto Neuroscience.