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
Anticipated 4th Quarter 2022
LUCID-PSYCH
Major Depression Disorder
Anticipated 4th Quarter 2022
FSD201
Inflamatory disorders
Anticipated 4th Quarter 2022
Lucid-MS
(Patented new chemical entity (NCE))
Lucid-MS is patented Neuroprotective compound which, in pre-clinical models, has shown to prevent and reverse Myelin degradation, which is a cause for Multiple Sclerosis as well as other Neuro-degenerative disorders. Has shown excellent results in several animal models
LUCID-MS: Disease Modifying
Enabling Remyelination
  • The subject shown in the video above is just one example taken from a large cohort of mice and the experiments have been done in multiple labs over several years. The results of the pre-clinical research from these experiments has been published in various medical journal: Journal of Medicinal Chemistry, The Proceedings of the National Academy of Sciences (PNAS). Lucid-MS is a patented NCE (New Chemical Entitiy) which has over 11 years of R&D work done on it. FSD owns the exclusive worldwide rights for Lucid-MS (patent #WO2017027967A1).
  • Excellent efficacy in various preclinical animal models
  • Treatment accelerates functional recovery of diseased mice, preserved myelin, and reduced axonal degeneration
  • Does not suppress immune system (non-immunomodulatory)
  • Potential oral administration with easy dosing regimen
  • Currently preclinical development in progress, with anticipated IND to be filed for FDA/HC approved phase-1 in-human clinical trials in the last quarter of 2022
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
  • Unpredictable pattern of symptoms (tingling, vision problems, mobility issues, etc.) has to do with which nerves a patient’s immune system attacks at any given time
  • The damage MS does to nerves can also affect critical thinking and other cognitive (mental) skills
  • Current treatment market valued at US $23 B globally 22
  • Female to male ratio 2:1
  • Prevalence — 1/1,000
  • Current treatment market valued at US$23 B globally
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
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.
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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