Cybin preps for ph3 as psychedelic clears depression trial

Tania Malréchauffé

Cybin has unveiled phase 2 results with its psychedelic medicine for major depressive disorder, which it says support moving the drug into a phase 3 programme.

Psilocybin analogue CYB003 achieved “rapid, robust, and clinically significant” improvement in depression symptoms after a single 12 mg dose in the study, said the company, meeting its primary endpoint.

The study, which enrolled subjects with moderate to severe MDD, looked at two doses of the psychedelic given three weeks apart and added to current antidepressant medication if it was being taken. At the first endpoint of three weeks, patients taking CYB003 saw a 14-point reduction on the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline, which was significantly better than placebo.

A second 12 mg dose showed an incremental benefit at six weeks, with a further 5.8-point MADRS improvement, according to Toronto-based Cybin. All told, 79% of patients were deemed to have responded to treatment and were in remission from depression at that time point.

The company maintains that the results are superior to those seen with currently approved antidepressants and other experimental psychedelics tested in MDD, with side effects that were “mild to​ moderate and self–limiting.”

Despite the data, investors in Cybin seemed to be somewhat underwhelmed and the company’s shares closed down more than 5% after the announcement, although, that may have been a correction after several months of upward growth.

There has been some volatility in the stock during a busy year that saw a couple of public offerings and the acquisition of UK-based psychedelics company Small Pharma and its N,N-dimethyltryptamine (DMT) candidate for MDD.

“Completing our phase 2 study and presenting this extraordinary topline safety and efficacy data represents a much-anticipated milestone for us – a goal that we have all been tirelessly working towards,” said Cybin’s chief executive, Doug Drysdale.

“Our objective remains to design and deliver improved treatments for those suffering with mental health disorders, and we believe that we are one step closer to achieving that goal,

Next up for the company will be an end-of-phase 2 meeting with the FDA, slated for the first quarter of 2024, and hopefully the start of a phase 3 study shortly thereafter. In the meantime, patients in the phase 2 trial will continue to be followed for 12 weeks to see how durable the effects of the therapy are.

Image by Tania Malréchauffé on Unsplash