Alto Neuroscience, Inc. presented data at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, reinforcing the safety and tolerability profile for ALTO-300 in Major Depressive Disorder (MDD). ALTO-300, an oral melatonin agonist and 5-HT2C antagonist, is being developed at a 25mg dose for biomarker-characterized MDD patients.
The company highlighted that the 25mg dose of agomelatine, the active compound in ALTO-300, has shown similar antidepressant activity to the 50mg dose approved in Europe and Australia, but without the reversible, low liver enzyme elevations associated with the higher dose. No liver function test (LFT) elevations of three times the upper limit of normal were observed in Alto's 239-patient completed Phase 2a trial.
Furthermore, no patients in the ongoing Phase 2b trial have been stopped due to liver enzyme elevation, which remains blinded. These data, combined with convergent clinical and preclinical evidence supporting the mechanistic link between ALTO-300 and its EEG biomarker, position the 25mg dose as a well-tolerated treatment option.
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