Cybin: Positive Clinical Trial On Psilocybin Analog For Major Depression & Updates On DMT Analog Program

Psychedelics biotech company Cybin Inc. CYBN shared progress updates for its two lead clinical development programs: proprietary deuterated psilocybin analog CYB003 for the potential treatment of Major Depressive Disorder (MDD) and proprietary deuterated DMT compound CYB004 for the potential treatment of Generalized Anxiety Disorder (GAD.) 

CYB003

Interim findings from the ongoing Phase 1/2a clinical trial showed positive outcomes, including a rapid and short-acting response in participants accompanied by tolerance and no serious adverse events after single oral doses of CYB003 at 1 mg, 3mg, 8mg and 10mg. 

Results confirm that the deuterated psilocybin analog holds low variability in plasma levels while being rapidly absorbed, and is capable of producing a psychedelic effect at low doses while maintaining a safe and well-tolerated therapeutic profile with effects being rapidly washed out.

On the other hand, participants administered 8mg and 10mg doses reported meaningful and robust psychedelic effects, achieving a complete mystical experience.

Dosing at Phase 1 has been completed and Phase 2a has begun, with topline results expected from the completed Phase 1/2a trial in late Q3 2023.

CEO Doug Drysdale called it “incredibly gratifying” that the interim readout findings of the Phase 1/2 clinical trial align with the results observed in preclinical studies. 

He added that the findings are encouraging regarding the potential efficacy of the underlying active agent, “which may ultimately reduce symptoms of depression after just one or two doses” and therefore constituting “a remarkable improvement” over chronic treatments currently available. 

“We are encouraged by the progress made in advancing our CYB003 molecule and look forward to continuing the momentum to advance this program through clinical development to bring this important treatment option to people who suffer from depression as quickly as possible,” Drysdale said.

CYB004

The Phase 1 trial in healthy volunteers has recently become a three-part study evaluating intravenous (IV) DMT infusion, IV DMT bolus plus infusion, and CYB004, which will allow dosing of CYB004 to begin sooner than initially planned. 

Specifically, data from the new parts of the trial will allow Cybin to ultimately optimize dose selection and formulation development for future clinical studies. 

The first part of the trial evaluating IV DMT in 40 participants is completed, with used dose ranges demonstrating to be safe and well-tolerated and dosing of IV DMT bolus plus infusion has begun. 

Dosing of CYB004 is expected to begin in early Q2 2023, with the expected sharing of the whole Phase 1 trial’s topline results in Q3 2023.

“Our CYB004 program has made significant progress marked by confirmatory results from Part A of the Phase 1 CYB004-E trial and the acceleration of first-in-human dosing of CYB004,” said Drysdale. “Recent protocol amendments will allow us to further evaluate CYB004 and demonstrate the advantages of deuteration on PK and PD parameters. We see the potential for short-duration treatments, which could truly transform the treatment paradigm and outcomes for patients. As well, we believe that deuteration may support less invasive and more convenient dosing methods for providers and patients.”

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Photo: Benzinga edit with photo by Olia Danilevich on Pexels.