It has been a busy week for psychedelic medicines developer Cybin, marked by a breakthrough designation (BTD) from the FDA for its depression therapy, new clinical data, and a new $150 million private placement.
The Toronto, Canada company says that the BTD is the first to be awarded for an adjunctive psychedelic-based therapy for the treatment of major depressive disorder (MDD), and comes as its CYB003 showed durable antidepressant effects over four months in a phase 2 trial.
The new data showed that 75% of patients who had received two 16 mg doses of deuterated psilocybin analogue CYB003 – given three weeks apart and on top of current antidepressant drugs – were in remission at that time point, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). In another group given two 12 mg doses the remission rate was 60%.
The mean reduction from baseline in the MADRS total score was approximately 22 points, which compared to a reduction of 14 points vs placebo and 17 points from baseline at three weeks when data from the study was first reported.
Cybin’s chief medical officer, Amir Imamdar, said the trial results show that CYB003 offers both a rapid and durable response in MDD, which “paves the way for a change in the treatment paradigm for MDD.” The company is now planning to start a phase 3 multinational study of CYB003 in MDD in mid-2024.
A BTD gives a drug an expedited review from the FDA, as well as a higher level of access to the regulator when discussing key aspects of a programme like trial design, and can shorten the time it takes to bring a new therapy to market.
Cybin joins a select group of psychedelic medicine developers with the status, which has also been granted to MindMed for its LSD-based candidate MM120 as a treatment for anxiety, COMPASS Pathways‘ psilocybin therapy for treatment-resistant depression, and US non-profit organisation MAPS for MDMA-based treatment of post-traumatic stress disorder (PTSD).
The FDA designation recognises that, despite the use of currently available treatments such as selective serotonin reuptake inhibitors (SSRIs), up to two-thirds of patients with MDD do not achieve remission with their initial antidepressant treatment. Over 43 million people in the US alone take antidepressants and over 70% of them are treated with SSRIs.
Cybin’s private placement will provide funds for the phase 3 programme and involves the sale of almost 349 million common shares at $0.43 apiece.
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