Psychedelics biotech company Cybin Inc. CYBN recently unveiled the results of its Phase 2 trial for its deuterated psilocybin derivative CYB003 for Major Depressive Disorder (MDD.) The trial demonstrated strong treatment efficacy after a single dose and even better outcomes following a second one.
The new topline, follow-up data confirms interim results published in October:
At three weeks: One 12mg dose of CYB003 showed a rapid, robust and clinically significant reduction of depression symptoms (primary efficacy endpoint achieved.) The combined 12mg and 16mg CYB003 cohorts displayed a mean 13.75 score on MADRS* vs. placebo (24 participants on CYB003 and 10 on placebo.)
At six weeks: Two 12mg doses of CYB003 led to incremental reductions in 79% of patients achieving remission from depression. It resulted in an additional 5.8 point improvement on MADRS total score (22 participants on CYB003 and 10 on placebo.)
Favorable safety and tolerability profile, with all reported adverse events at all doses tested being mild to moderate and self-limiting.
*The Montgomery–Åsberg Depression Rating Scale (MADRS) is a ten-item questionnaire used by psychiatrists to measure the severity of depressive episodes. The system involves scores 0-6, with a total score outcome from 0 to 60.
CYB003 Vs. Antidepressants
Comparing it to conventional antidepressants and other psychedelics, the new data supports the deuterated psilocybin’s ability to produce an improvement that greatly surpasses the average by standard medications like SSRIs. The novel psychedelic’s effect size is proving to be up to 10 times higher than that of traditional medication, as stated by Cybin’s CMO Dr. Amir Inamdar.
On the opposite end, CYB003 seems to produce a high remission rate, plus rapid and significant symptom reduction after a single dose, with an average 13.75 score (one dose of either 12mg or 16mg of CYB003.)
The Science Discussed And Heading To 2024
The outcomes were presented and examined at Cybin’s investor meeting in NYC on Nov. 30, along with a more general R&D briefing including the participation of Dr. Maurizio Fava (Mass. General Hospital and Harvard Medical School) and Prof. Dr. Gitte Moos Knudsen (Rigshospitalet and University of Copenhagen.)
The specialists discussed research on deuterated psilocybin for depression and deuterated DMT for anxiety treatment (see CYB003 and CYB004 programs.) They also talked about how deuteration could provide “consistent and reliable” psychedelic treatments by optimizing pharmacokinetics without adversely affecting the molecules’ underlying pharmacology, reducing in-clinic times, and offering intermittent dosing vs. chronic daily treatments, all with “rapid and sustained” therapeutic effects.
Dr. Fava led the largest clinical trial on depression, StarD, which dosed all participants with an SSRI for 12 weeks. The outcomes were that only one in three patients remitted after that time.
“So three months of treatment, and one-third of patients remitted, half of which did so between week 6 and 12. So standard antidepressants unfortunately have the significant limitation of limited efficacy, which furthermore takes time,” he shared.
For Dr. Knudsen, who delved into how psychedelic compounds work, it’s “really remarkable” that just a single psychedelic dose of a compound can have “such sustainable and long-acting effects,” as compared to any other known drug.
See Also: Cybin Reports Access To $101M To Sustain Deuterated Psychedelics Programs, Q2 Numbers & 2024 Goals
CEO Doug Drysdale said he believes the findings are not only significant for Cybin, but “in terms of progressing the whole mental health sector,” constituting “the biggest breakthrough in psychiatric pharmacology in the last 40 years” and holding “the potential to transform the way we treat mental illness and improve patient outcomes.”
CMO Dr. Inamdar supported the notion, stating they “can only be described as extraordinary topline results from a Phase 2 study.” See the full discussion and outcomes’ analysis here.
Next on the list for Cybin is submitting it to the FDA and requesting the federal agency an end-of-Phase 2 meeting for Q1 2024. With additional 12-week durability data from the Phase 2 study expected by next Q1 as well, Cybin anticipates -pending approval- to start recruiting for the Phase 3 study by the end of Q1 2024.
Photo: Benzinga edit with photo by Photon photo and Jynto on Wikimedia Commons.