Alto Neuroscience announces initiation of Phase 3 study of ALTO-203

Alto Neuroscience announced the initiation of its Phase 2 double-blind, single- and multiple-dose study to determine the pharmacodynamic effects of ALTO-203 in MDD patients as well as assess its safety, tolerability, and pharmacokinetics. To date, ALTO-203 has demonstrated positive emotional and cognitive effects in healthy participants after a single dose. The present study will evaluate these effects in patients with MDD to determine the potential of ALTO-203 as an antidepressant. “This is the fifth Phase 2 study we have initiated across our pipeline, a milestone that marks significant progress in our efforts to redefine mental healthcare through our Precision Psychiatry Platform,” said Jessica Powell, chief development officer of Alto Neuroscience. “In a Phase 1 study, ALTO-203 demonstrated an acute increase in positive emotion relative to placebo and across several dosage levels. We look forward to completing this proof-of-concept study in patients as we believe this response may be an important attribute of an antidepressant to benefit patients with MDD and higher levels of anhedonia specifically.”