Cybin to Begin Phase 3 Trial of Treatment for Major Depressive Disorder This Summer

MT Newswires Live08-13

Cybin (CYBN) Tuesday said it expects to begin phase 3 testing of its CYB003 drug candidate to treat major depressive disorder later this summer following a recent Type B initial breakthrough therapy meeting with the US Food and Drug Administration.

The Canadian drug maker plans to implement several measures to reduce the risk of functional unblinding during the upcoming trial, including using a three-arm design with a high dose, mid-dose and placebo arm and relying on independent, blinded raters who will not have any information on the trial subject's dosing, it said.

During phase 2 testing, the company said CYB003 showed a robust and sustained effect, with 75% of the patients with depression still in remission four months after receiving two 16-milligram doses. Cybin said it anticipates reporting 12-month efficacy data from the mid-stage study in Q4.

Cybin shares were about 3% lower in recent trading.

Price: 0.26, Change: -0.01, Percent Change: -3.02

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