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Canadian biotech using AI-assisted drug discovery at the University of Alberta to develop novel psilocybin and MDMA analogues for mental health and addiction treatment. Pipeline compounds MYCO-003 through MYCO-007 represent a library of psychedelic-inspired molecules at preclinical stage.

Development Programmes

2

MYCO-001

Psilocybin
Phase II

Smoking cessation / PTSD

Programme Tracker

Substance Use Disorders (SUD)

Primary: US (FDA)
Phase IIActive

Phase 2b multi-site placebo-controlled trial; PI: Dr. Matthew Johnson (Johns Hopkins); sites: Hopkins, NYU, UAB; IND filed with FDA

Milestones

Phase II started

Completed

Actual: Sep 1, 2022

Phase 2b seamless smoking cessation trial initiated with Johns Hopkins partnership; IRB conditional approval received

Why it matters: MYCO-001 is a 99.9% pure natural-source psilocybin developed in partnership with Johns Hopkins' Dr. Matthew Johnson — the researcher behind the landmark 2022 JAMA Psychiatry smoking cessation study (80% abstinence at 12 months). The Phase 2b replicates this design at multiple sites.

Watch next: Phase 2b 3-month and 6-month abstinence primary endpoint results

Recorded Events

Sep 1, 2022: Phase II started

PTSD

Primary: UK (MHRA)
Phase IIActive

Phase 2a in veteran PTSD; partnership with Combat Stress (UK) and King's College London; PI: Dr. Rakesh Jetly

Milestones

Phase II started

Completed

Actual: Jan 24, 2022

Partnership with Combat Stress and King's College London announced for veteran PTSD trial

Why it matters: Dr. Rakesh Jetly is the leading clinical researcher for psilocybin PTSD trials in veterans. Combat Stress is the UK's leading veteran mental health charity. This partnership brings credibility and access to a high-burden, treatment-resistant PTSD population.

Watch next: Phase 2a results in veteran PTSD cohort

Recorded Events

Jan 24, 2022: Phase II started

MYCO-004

Pre-clinical

Substance use disorder / smoking cessation

Programme Tracker

Substance Use Disorders (SUD)

Primary: US (FDA)
Pre-clinicalActive

Preclinical development of patch-delivered tryptamine formulation for substance use disorder and smoking cessation

Milestones

Pre-clinical completed

In progress

Why it matters: MYCO-004 is a transdermal tryptamine — distinct from MYCO-001's oral psilocybin. Patch delivery could enable controlled, slow-release dosing (potentially sub-perceptual) without the 4–6 hour oral psychedelic session, expanding access to patients unwilling or unable to undergo full psychedelic sessions.

Watch next: Preclinical PK/PD data and indication selection for IND

Quick Facts

Type
Public Biotech
Ticker
NEO: MYCO
Lead Stage
Phase II
Website
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