An update on psychedelic therapies from Cybin

"Current treatments for depression today are frankly depressing"said Cybin CEO?Doug Drysdale?at the top of a call to provide us with an update on the company's progress on developing psychedelic therapies for depression and anxiety.

Drysdale highlighted that selective serotonin reuptake inhibitors (SSRI) drugs are the current standard of care for these mental health conditions, but they need to be taken daily for weeks or months to become effective. They also come with a 1-in-3 chance of remission and a 1-in-4 likelihood of side effects, such as weight gain, insomnia and sexual dysfunction, which can last for years after dosage.

Psychedelics on the other hand only need to be given in one or two doses with effects lasting between six and 12 months and can be considered as?"pharmaceutical interventions", Drysdale added. Indeed, 65 clinical studies on psilocybin have demonstrated efficacy, with data being prepared for submission to the FDA.

With this mind, Drysdale explained that Cybin is developing therapies based on classic psychedelic molecules that we've known about for millennia, such as psilocybin (found in magic mushrooms) and dimethyltryptamine (DMT). It's creating synthetic versions and modifying them into pharmaceuticals with optimised pharmacokinetics that improve patient experience and are scalable for use in the health care system.

Although these drugs will not be a silver bullet cure for depression and anxiety, they will certainly broaden the landscape of treatments available to clinicians.

Among Cybin's development portfolio is?CYB003, which is being evaluated as a potential treatment for major depressive disorder (MDD). Efficacy data from Phase 2 testing of the deuterated psilocybin analogue is set to begin this month, which will be submitted to the FDA by year-end. Drysdale described this as a?"huge leap"?for Cybin, with significent progress over the past year. CYB003 is also being explored as a treatment for alcohol use disorder.

Trials have shown the treatment can become effective within 15 minutes of dosage, with peak effects lasting around two hours and low variability in plasma levels. At a dose of 10 mg, more than half of participants gave a mystical experience questionnaire (MEQ) score of over 70%, indicating a?"complete mystical experience", with some describing it as being in the?"top most enlightening experiences"?of their life. Additionally, the drug indicates a?"very favourable"pharmacokinetic profile?consistent with efficacy.

CYB004, a deuterated DMT (dDMT), is being investigated as a potential treatment for generalised anxiety disorder. Authorities in the Netherlands will start first-in-human dosing of the drug imminently. The study is critical for dosage optimisation since metabolism outruns the absorption rate of DMT.

As these drugs need to be taken under supervision, Cybin has also developed a programme called?EMBARK?to train facilitators to guide patients through psychedelic therapies in clinical trials. Drysdale shared a video of the several facilitators involved with the depression study, in which they spoke about what participants thought about the treatment. Responses included feeling?"an increased ability to accept love and affection"?and being able to?"feel safe in my life again".

Cybin's innovative approach has not gone unnoticed. Last week, the firm?announced?a 36-month, $30M common stock purchase agreement from Lincoln Park Capital Fund, to be executed at Cybin's discretion – strengthening the company’s position to deliver on value-driving clinical milestones. Further, the deal comes with no warrants or derivatives that could dilute existing shareholders further down the line.

According to Drysdale,?"in the future, psilocybin will be the treatment choice before SSRIs?[selective serotonin reuptake inhibitors].?Patient testimonials from non-blind tests will soon bring attention to our success".

Questions and answers

Here are a few other snippets from our call...

Do you consider the portfolio drugs scalable given the administration through supervision??Drysdale?"The drugs are relatively short-acting so the clinical time is short. CYB003 is taken orally no administration required and CYB004 can be administered, through an IV, in any clinic or therapy office over a 45-60 minute period."

Are you in discussions with healthcare providers or insurers??Drysdale "Yes, depressed patients are more likely to have diabetes, obesity etc. Therefore Cybin keeps them out of the healthcare system, so payers are very excited about our pipeline."

What’s the competitive landscape like??Drysdale "Compass Pathways?is ahead at the moment but this will be a market with many winners. Every piece of data issued by Compass de-risks Cybin development."

What are the next big milestones??Drysdale "Efficacy data in the fall and a potential?breakthrough therapy?granted by the FDA this year."