Where Are Psychedelics Headed In 2023? These Two Heavy Hitters Share Their Plans

It’s the beginning of 2023 and psychedelics companies are updating the public on their developmental and clinical progress as well as their selected milestones for the year.

Cybin’s Programs For MDD And Anxiety Disorders

Cybin Inc. CYBN outlined its near-term goals regarding the CYB003 and CYB004 clinical programs, which CEO Doug Drysdale believes “will provide important information” to help strengthen the company in the progression of its investigational therapies towards undertreated mental health conditions.

The proprietary psilocybin analog CYB003 is being assessed in a Phase 1/2a study for the treatment of Major Depressive Disorder (MDD). 

As a deuterated form of the first-gen psychedelic, CYB003 is designed to potentially address the challenges and limitations of oral psilocybin, such as variability in plasma levels, drug onset, and duration of effect. 

Interim results from this Phase 1/2a trial will be shared in February and will include the safety and pharmacokinetic (PK) profile of the drug, such as observations of the characteristics and duration of its psychedelic effect.

The findings would provide information on the necessary dose ranging for the ongoing trial plus upcoming clinical studies of CYB003, as the company aims to secure more consistent and predictable dosing, and reduced intra- and interindividual variability.

The other proprietary psychedelic, CYB004, is an intravenous (IV) DMT deuterate designed for the treatment of anxiety disorders and is being tested in a Phase 1 trial on its safety and dosing optimization. 

In its natural form, DMT is rapidly metabolized in the body and is not orally bioavailable, something CYB004 could overcome by increasing oral and pulmonary bioavailability, providing faster onset with lower doses, lower inter-subject variability, and better dose titration for fewer side effects compared with oral and IV DMT as preclinical results show so far.

To date, the Phase 1 clinical trial has not shown any significant safety or tolerability issues. Cybin expects to translate key learnings from the initial study -including dose optimization and dynamics- to the development of the remaining planned cohorts and will most likely share an update on this program in February as well.

MindMed’s LSD Trial

Mind Medicine Inc. MNMD’s corporate update and outlook for this year includes readouts of the results of its Phase 2 LSD clinical trials, the launch of a new compound’s clinical program, and a solid cash flow to support its operations all the way into 2025.

"Following a year of continued strong execution, our progress in 2022 has set the stage for a meaningful 2023, a year in which we plan to further elucidate the potential of our MM-120 product candidate in Generalized Anxiety Disorder (GAD) and initiate the first clinical trial for our MM-402 program," stated CEO Rob Barrow. 

Barrow added that MindMed’s focus remains on progressing its programs. Specifically, in 2023 the company expects to share key data on its Phase 2b study of MM-120 for the treatment of GAD and on its Phase 2a trial of repeated low-dose MM-120 in Attention-Deficit/Hyperactivity Disorder (ADHD), plus the new MM-402 Phase 1 trial, all of which would be funded by the company’s “strong financial position” well beyond the key milestones and up to the first half of 2025.

MM-120 is MindMed’s proprietary form of LSD being developed primarily for the treatment of GAD. MM-402 is the R-enantiomer of MDMA, and is designed to treat the core symptoms of Autism Spectrum Disorder (ASD). 

With preclinical results of MM-402's effects to be presented in the first half of 2023, the company plans to initiate the first clinical trial this year assessing tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) as well as early signals of efficacy on core symptoms of ASD.

On the other hand, University Hospital Basel in Switzerland is one of MindMed’s regular collaborators, which is currently enrolling participants for a Phase 1 trial comparing tolerability, PK and acute subjective, physiological and endocrine effects of R(-)-MDMA, S(+)-MDMA and R/S-MDMA.

MindMed expects to host a virtual analyst and investor day in the first half of 2023, to be hosted by the company's management team, plus the presence of a physician expert and key opinion leaders.

Photo: Benzinga edit with photo by Raimundo79 and Blue Planet Studio on Shutterstock.