Cybin Holds ‘Productive’ Meeting with FDA to Discuss Plans for CYB003

Cybin executives recently met with representatives from the U.S. Food & Drug Administration to discuss Cybin’s plans for CYB003, the company’s deuterated psilocybin analog.

After the “productive Type B meeting” with the FDA in Washington, D.C., Cybin CEO Doug Drysdale reiterated the company’s plans to initiate its Phase 3 trial of CYB003 for the adjunctive treatment of MDD later this summer.

“Having selected 30 clinical sites across the United States and Europe, we are eager to initiate this next phase of clinical development and to build on the positive impact of CYB003 to date,” Drysdale added in a news release. “In our Phase 2 study, CYB003 showed a robust and sustained effect, with 75% of patients in remission from depression four months after two 16-mg doses. We expect to report 12-month efficacy data from the Phase 2 study in the fourth quarter of this year. We look forward to ongoing engagement with the FDA as we advance our path to bringing new, improved treatment options to patients and providers.”

The company also shared its plans to implement multiple measures to attempt to mitigate the risk of functional unblinding in the study. According to Cybin:

• The study will include one study with a three-arm design with a high dose, mid-dose and placebo arm. Patients will not know if they received the therapeutic high dose or the sub therapeutic mid-dose, mitigating the unblinding to an extent and addressing potential expectancy bias.
• The study will utilize remote, independent, blinded raters who will not have any information on the dose received or the participant’s dosing experience.
• The reporting of effects during the dosing session will be firewalled to ensure that the study team stays blinded.
• The studies will recruit participants who are largely “psychedelic-naïve” to reduce the impact of expectancy bias.
• The studies will assess long-term efficacy data points up to one year, to outlast any potential expectancy effects.

In addition, the study will include manual and real-time artificial-intelligence screening of monitoring sessions to ensure monitor fidelity and patient safety, according to the company.