After ‘Positive’ FDA Meeting, Cybin Looks Ahead to Phase 3 CYB003 Program

Cybin said it had a “positive” End-of-Phase-2 meeting with the U.S. Food & Drug Administration to discuss CYB003, the company’s deuterated psilocybin analog for the adjunctive treatment of major depressive disorder.

Cybin completed the Phase 2 study of CYB003 in late 2023.

“The company has received minutes from its End-of-Phase-2 meeting with the FDA and reached alignment on its Phase 3 program design,” the company said in a news release.

Cybin said it plans to start enrollment for the multinational, multisite Phase 3 program this summer.

The company is targeting 15 U.S. study sites, all of which have experience running psychedelic clinical trials and are “DEA Schedule I licensed,” according to Cybin. The company said it intends to add approximately 8 additional sites in Europe.

“We are very pleased with the results of our End-of-Phase-2 meeting with the FDA and appreciate the agency’s thoroughness and guidance during the process,” Cybin CEO Doug Drysdale said in a news release.

To date, the clinical testing has shown that at four months after dosing, across the two doses, 60% of patients receiving 12 milligrams and 75% of patients receiving 16 milligrams of CYB003 achieved remission from depression symptoms, Drysdale noted.

“With positive durability data demonstrating sustained effects up to at least four months, [FDA breakthrough-therapy designation] and alignment with the FDA on our Phase 3 plan, we are positioned to move quickly to progress the program and bring relief and treatment alternatives to people who are desperately waiting,” Drysdale added.

Cybin has engaged the contract research firm Worldwide Clinical Trials to help manage the Phase 3 clinical trials. Worldwide has recent experience managing psychedelic studies in psychiatric populations, Cybin noted.