FSD Pharma has a pipeline of the following 3 drug candidates:
Idea/Target Lead In vivo PoC IND Enabling Studies Phase 1 Phase 2 Phase 3 Launch
LUCID-MS
Multiple sclerosis
Q1-Q3 2023
(Phase-1)
LUCID-PSYCH
Major Depression Disorder
Q1 2023
(Phase-1 submission)
FSD201
Inflamatory disorders
Q4 2022
(recruiting started, Jan 2023)
Lucid-MS
(Patented new chemical entity (NCE))
Lucid-MS is a patented neuroprotective compound that has demonstrated in preclinical models to prevent and reverse myelin degradation, a cause for Multiple Sclerosis, as well as other neurodegenerative diseases and conditions. Lucid-MS has shown excellent results in several animal models, as demonstrated in the video below.
LUCID-MS: Disease Modifying
Enabling Remyelination
The subject in the video above is only one example taken from a large cohort of mice in experiments conducted in multiple labs across several years. The results of the preclinical research from these experiments has been published in various prestigous medical journals, including Journal of Medicinal Chemistry and Proceedings of the National Academy of Sciences (PNAS). Lucid-MS is a patented ((patent #WO2017027967A1) New Chemical Entity (NCE) that has been studied extensively throughout more than 11 years of research and development. FSD Pharma owns exclusive worldwide rights to Lucid-MS.

A sampling of the novel qualities of Lucid-MS include:
  • Excellent efficacy in various preclinical animal models
  • Accelerates functional recovery of mouse models of Multiple Sclerosis, preserves myelin, and reduces zonal degredation
  • Does not suppress immune system (non-immunomodulatory)
  • Potential oral administration with easy dosing regimen
In Q1 2023, FSD Pharma received approval from Health Canada in the form of a “No Objection Letter” to proceed with a proposed Phase 1 clinical trial that will evaluate the safety and tolerability of Lucid-MS as a new drug candidate for the treatment of Multiple Sclerosis.
Today there is no cure for Multiple Sclerosis.
FSD Pharma (“HUGE”) is trying to change this for millions of people
MS Overview
  • A chronic inflammatory and degenerative disorder of the Central Nervous System Global prevalence of MS rose from 2.3 million in 2013 to 2.8 million in 2020
  • MS is characterized by unpredictable symptoms (i.e. tingling sensations, vision problems, mobility issues) that are attributed to the patient’s immune system attacking different nerve fibers
  • Damage to myelin (the sheaths protecting nerve fibers) can affect critical thinking and cognitive skills
  • Global MS treatment market in 2022 estimated at US$23 billion
  • MS can occur at any age, but the average age for diagnosis globally is 32 years 1.5% of the global MS population is under the age of 18 years
  • Female to male diagnosis ratio is 2:1
  • Prevalence in U.S. is 288 cases per 100,000 people; in Canada it is 250 cases per 100,000 people
Armed with a strong balance sheet, solid pipeline, and renowned clinical team, FSD intends to advance its lead drug candidates through clinical trials with the goal of providing therapies to the millions suffering from neurodegenerative and neuropsychiatric conditions.
Lucid-PSYCH
(Psycho-active)
Lucid-PSYCH is a psycho-active molecule. Has shown excellent results for depression in pre-clinical models. Manufacturing has been secured with Covar. Currently undergoing IND-enabling studies
Lucid-PSYCH video
FSD Pharma Differentiation (Lucid-PSYCH)
Lucid-PSYCH
Development Stage Preclinical
Target Condition Mental health and neurodegenerative conditions
Proprietary molecules Yes
Time to Market 5-8 years
IP/Innovation Yes
Market Access Strategy Multiple entry points
Major Depressive Disorder (MDD) (Lucid-PSYCH)
MDD Overview
  • Characterized by depressed mood or loss of interest in pleasure for at least 2 weeks
  • Periods of remission and relapse over a lifetime
  • 300 million people worldwide living with depression
  • 10% of Canadians will experience MDD at some point in their life
  • 13 million adults with MDD in the U.S.
  • 3% incidence rate globally
  • Economic burden in U.S. of $210 billion annually
  • First line treatment is antidepressants with or without psychotherapy
Psychedelics market for mental Illness
1Billion
162M
264M
300M
322M
FSD201
FSD201 is an anti-inflammatory compound and has the potential to address a range of inflammatory conditions. FDA approved phase 1 trials have been completed with topline results. Toxicology studies have been complete. Clearance received to proceed with phase-2 trial for nociplastic pain associated with Idiopathic Mast Cell Activation Syndrome. Phase-2 trials are currently ongoing.
FSD201 video
FSD201 Overview
Proprietary Formulation
Proprietary formulation enhances the anti-inflammatory properties of PEA, a fatty acid amide currently used as a dietary supplement, by increasing its bioavailability and efficacy- making it suitable to treat a range of inflammatory conditions
Exclusive Worldwide Licensing Rights
FSD Holds exclusive worldwide licensing rights (except Italy & Spain) to ultra micro-PEA for all conditions in all regulatory categories
Strong IP Portfolio
Strong IP portfolio covering ultra-micronized composition of matter and use (2029-34 U.S. expiration) FSD201 (600mg ultra micro-PEA)
Lead Candidate
Successfully completed Phase I first-in-human safety and tolerability trial; no serious adverse effects reported Toxicology trials have been completed and Clearance received from Health Canada and FDA (Food and Drug Administration) in US to proceed with phase-2 trials. Phase-2 trials are currently ongoing
Target Indications
Nociplastic pain associated with Idiopathic Mast Cell Activation Syndrome
An anti-inflammatory agent
  • A well-researched compound in preclinical and clinical studies
  • Addresses large markets with growth opportunities in opioid-sparing indications (pain, post-surgical pain, morphine tolerance, etc.), endometriosis, osteoarthritis, fibromyalgia, etc.
  • A “Pharmaceutically Green” API, a growing trend in inflammatory and related therapeutics
  • Proposed mechanism of action of PEA with red lines indicating canonical signaling, black lines as strongly supported, and grey as hypothesized (the Basal Pharmacology of Palmitoylethanolamide)

Proposed mechanism of action of PEA with red lines indicating canonical signaling, black lines as strongly supported, and grey as hypothesized (the Basal Phermacology of Palmitoylethanolamide)

  • An endogenous compound, and a key regulator of endocannabinoid system in inflammation
  • PEA activates GPR55 and PPAR-α receptors, leads to increased expression of CB2 receptors
  • PEA increases the endogenous levels of 2-AG and AEA, which directly activate CB1, CB2, and TRPV1 receptors
  • PEA inhibits the activation of mast cells (peripheral)
  • PEA reduces the activation of microglia and astrocytes (CNS)
  • Clinical data available that suggests that FSD201 is superior to Pregabalin, Dulexitine, Ibuprofen and the opiates in the treatment of pain

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