Single Dose Of Cybin's Psilocybin Shows Compelling Patient Outcomes, Phase 2 Results Find

Psychedelics company Cybin Inc. CYBN shared its Phase 2 study interim results for its psilocybin analog CYB003 on Major Depressive Disorder (MDD) paired with the company’s EMBARK psychotherapy. 

The new data met the trial’s primary efficacy endpoint: A rapid, robust and statistically significant reduction in depression symptoms three weeks after a single 12mg dose of the company’s deuterated compound (n=15,) as compared to placebo (n=6.) The difference between the two groups is reportedly unprecedented -14.08 points on the MADRS scale.

These results take considerable relevance vis-a-vis a 2022 study showing data from 232 industry studies of current standard-of-care antidepressants (SSRIs) submitted to the FDA, where the average improvement was 1.82 points vs. placebo to which the benefits of CYB003’s intermittent dosing (vs. daily) would be added. 

Results

Of total 21 participants, 53.3% showed a robust response; 20% were in remission three weeks after the single 12mg dose, vs. 0% in the placebo group. 

Symptoms improvement reached a peak at 10 days post-dosing and maintained for the following 11 days. 

As for safety and tolerability, the dose showed a favorable profile, eliciting no serious adverse events. 

The placebo response was relatively small, more so when compared to other clinical trials (see cautious analysis by Psychedelic Alpha) assessing non-deuterated psilocybin.

While deuteration can change original psilocybin’s pharmacokinetics, CEO Doug Drysdale said at Cybin’s investor conference that the aim is to apply the process to psychedelic molecules “without affecting their underlying pharmacology.”

CYB003 has reportedly shown a faster onset of psychedelic effects -around 15 minutes following dose - shorter overall effects duration with acute ones lasting an average two hours in addtion to a favorable safety profile.

Cybin’s CMO Dr. Amir Inamdar added that, considering frequent comorbid MDD in psychiatric disorders like anxiety and PTSD, the new data is also relevant as it points at CYB003’s potential therapeutic efficacy for “a range of mental health conditions.”

See Also: Depression Relief: Possible Therapy Boost With DMT & SSRIs, Per Small Pharma Clinical Results

Prospects

Full Phase 2 topline data is due within 2023’s last quarter, 12-week durability data is set for 2024’s first quarter, and an upcoming large multisite Phase 3 trial would launch sometime in early 2024, following an end-of-Phase 2 meeting with the FDA.

The company also expects to share topline Phase 1 data for its proprietary deuterated DMT compounds, CYB004 and SPL028 -see recent acquisition of Small Pharma-, before the year ends toward initiating Phase 2 studies in participants with Generalized Anxiety Disorder (GAD) in 2024’s first quarter. The GAD population would have an 80% overlapping symptomatology to MDD patients, Dr. Inamdar explained. 

The quarter would also host a CYB004 subcutaneous (SQ) formulation study, and a SPL028 intramuscular (IM) trial.

Market Replies

Cybin’s progresses haven’t gone unnoticed by those investing in the psychedelics space, as shows Mets owner Steve Cohen’s Point72 firm considerable buy this September; or, more recently, HC Wainwright’s reiterated shares acquisition, and the stock’s price rise on October 31 following the announced interim results -from $0.6 at Monday’s close to almost $0.65 on Tuesday’s opening and peaking to $0.67 shortly thereafter.

As of Wednesday, Nov. 1, the number seems to have readjusted with price pivoting between $0.57 and $0.61.

Photo: Benzinga edit with photo by chrissmith12 and Bru-nO on Pixabay.