Cybin gears up for registrational trial of psilocybin analog in major depression after PhII success

Cy­bin’s psy­che­del­ic-in­spired drug can­di­date has met the pri­ma­ry end­point of its mid-stage test in ma­jor de­pres­sive dis­or­der (MDD), spark­ing prepa­ra­tions for a Phase III tri­al set to start en­rolling next year.

The Cana­di­an biotech is aim­ing to en­roll 220 pa­tients in­to the Phase III tri­al, CEO Doug Drys­dale told End­points News in an email.

Cy­bin’s Phase I/IIa study eval­u­at­ed sev­er­al dos­es of its deuter­at­ed ana­log of psilo­cy­bin, dubbed CYB003, in 68 peo­ple with and with­out MDD. The MDD sub­jects had un­re­spon­sive mod­er­ate-to-se­vere dis­ease and were on a sta­ble dose of SS­RIs. The Phase II por­tion set CYB003 against place­bo in over 30 pa­tients.

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