drug development
Paving the way in botanical psychedelic drug development.
In-house Development Program
We are demonstrating the safety and efficacy of botanical psychedelic drug candidates for the first time in human clinical trials:
Stimulant Use Disorder
In the latest (2021) national survey, 11 million Americans reported stimulant misuse and 4.5 million reported a stimulant use disorder (StUD)1
- From 2012 through 2019, the fatal overdose rate increased on average by 29% per year to 5.0 deaths per 100,000 standard population2
- Side effects of StUD include violent outbursts and aggressive behaviour
- Three subcategories share similar or identical mechanisms of action:
- Methamphetamine use disorder, cocaine use disorder and prescription stimulant use disorder
- There are no approved treatments for StUD
- Filament estimates addressable StUD patient population of 835,000 with peak annual revenues of US$1.2 billion3
Sponsor
Indication
Phase I
Phase II
Phase III
Start
n
Product
Purpose
Healthy Volunteers
UCSF
Dosing
20
PEX010, 020, 030
Assess the benefits of directly administering psilocin orally (PEX020) and sublingually (PEX030)
Methamphetamine Use Disorder
Filament
Q4 2023*
10
PEX010 (25mg)
Pilot open label study - Psilocybin for Methamphetamine Use Disorder. Planned 50 person multicentre study, Q1 2024*
Approval Pending
Trial Approved
*Anticipated start date
Opioid Use Disorder
In the latest (2021) national survey, 9.2 million Americans reported opioid misuse of which 5.6 million reported an opioid use disorder (OUD)1
- Overdose deaths nearly doubled from 7.4 to 15.5 deaths per 100,000 standard population from 2012 to 20192
- The global opioid use disorder pharmaceutical market is projected to grow from $3.35 billion in 2023 to $6.14 billion by 2030, at a CAGR of 9.1%3
- Existing therapies are poor:
- Substitution therapy replaces misused opioid with prescription opioid agonist (58% retention at 6 months4)
- Antagonist therapy requires complete detox and abstinence and monthly injections, and can lead to more deadly relapses (50% 6-month retention5)
- Filament forecasts addressable OUD patient population of 295,000 with peak annual revenues of ~$387 million6
Sponsor
Indication
Phase I
Phase II
Phase III
Start
n
Product
Purpose
Healthy Volunteers
UCSF
Dosing
20
PEX010, 020, 030
Assess the benefits of directly administering psilocin orally (PEX020) and sublingually (PEX030)
Opioid Use Disorder
Filament
Q4 2023*
10
PEX010 (25mg)
Pilot open label study - Psilocybin for Opioid Use Disorder. Planned 50 person multicentre study, Q1 2024*
Approval Pending
Trial Approved
*Anticipated start date
Partnership network development program
Revenue-Generating Licensing Partnerships
Filament has partnered with leading researchers worldwide to advance natural psychedelic research and generate revenue.
We believe that our botanical drugs could be effective in many therapeutic areas and that research on multiple indications is necessary. Our patented technology provides an attractive platform whereby third-party drug developers can leverage our IP and regulatory expertise by using Filament’s drug candidates in their clinical trials.
This provides Filament with the opportunity to obtain near-term milestone-based revenue and royalties upon commercialization.
Sponsor
Phase I
Phase II
Start
Intervention
Indication
Location
Q1 2023*
Psyence Group
PEX010 (25mg)
Palliative Care
UK/London
Q1 2023*
Cybin Therapeutics
PEX010 (25mg)
Depression
Canada/Vancouver
Q1 2023*
EntheoTech Bioscience
PEX010 (25mg)
Opioid Tapering
Canada/Okanagan
Q1 2023*
EntheoTech Bioscience
PEX010 (25mg)
Chronic Pain/Depression
Canada/Okanagan
Q3 2022
ATMA Journey Centers
PEX010 (25mg)
Therapist Training
Canada/Alberta
Q2 2023*
ATMA Journey Centers
PEX010 (25mg)
COVID Mental Health Concerns – Frontline HC
Canada/ Alberta
Approval Pending
Trial Approved
*Anticipated start date
Academic AND Philanthropic Low-cost Partnerships
We provide low- or no-cost study drugs to academic researchers and retain safety data for in-house programs.
This is one way in which we give back to the psychedelic research community. We also gain insights into new indications and safety data for future regulatory filings.
Sponsor
Phase I
Phase II
Start
Intervention
Indication
Location
Q1 2023*
University of Toronto
PEX010 (1mg)
Depression
Canada/Toronto
Q1 2023*
University of Liège
PEX010 (25mg)
Coma
Belgium
Q1 2023*
Brugmann University Hospital
PEX010 (25mg)
Alcohol Use Disorder
Belgium
Q2 2023*
University of Calgary
PEX010 (1mg)
Alcohol Use Disorder
Canada/ Alberta
Q1 2023*
Copenhagen U. Hospital
PEX010 (25mg)
Alcohol Use Disorder
Denmark
Q2 2023*
Centre for Addiction and Mental Health
PEX010 (25mg)
Treatment Resistant Depression
Canada/ Toronto
Q2 2023*
Centre for Addiction and Mental Health
PEX010 (25mg)
Mild Cognitive Impairment
Canada/ Toronto
Q2 2023*
Ottawa Research Hospital
PEX010 (1mg)
Existential Crisis
Canada/Ottawa
Approval Pending
Trial Approved
*Anticipated start date