Next-generation psychedelics biotech Cybin Inc. CYBN released the full Phase 2 trial results of its deuterated psilocybin derivative CYB003 for Major Depressive Disorder (MDD.) Although a relatively small trial, outcomes for the novel psychedelic are so far showing strong treatment efficacy after a single dose and “a clear incremental benefit” following a second one.
The new topline, follow-up data reaffirms 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.) Specifically, 12mg and 16mg CYB003 cohorts combined showed 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 showed incremental reductions in 79% of patients in remission from depression. Specifically, it propelled an additional 5.8 point improvement on MADRS total score (22 participants on CYB003 and 10 on placebo.)
Favorable safety and tolerability profile, 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 widely accepted by regulatory authorities as a standardized testing metric. The system involves scores 0-6, with a total score outcome from 0 to 60.
CYB003 Vs. Antidepressants
When compared to conventional antidepressants and other psychedelics, the new data is supportive of 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 Cybin’s CMO Dr. Amir Inamdar.
Treatment with traditional antidepressants holds an average 1.82 points in MADRS [pooled data of 200+ industry studies.] This adds to standard medications being considerably more slow-acting, plus holding a relatively slow drug intake adherence, bringing about high recurrence and relapse rates and eventually treatment failure.
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
Results were presented and examined at Cybin’s investor meeting in NYC on Nov. 30, along with a more general R&D briefing with 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,) and 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 served in 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.
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 backed 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 -approval pending- 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.
Image and article originally from www.benzinga.com. Read the original article here.