micro-palmitoylethanolamide (FSD-PEA) / Quantum BioPharma - LARVOL DELTA

Safety and Efficacy of FSD201 for the Treatment of Chronic Pain Associated With Idiopathic MCAS (MCAD) (clinicaltrials.gov) - P2 | N=2 | Terminated | Sponsor: FSD Pharma, Inc. | N=60 ➔ 2 | Recruiting ➔ Terminated; For business reasons and not for reasons related to safety or efficacy

Enrollment change • Trial termination • Musculoskeletal Diseases • Pain • IL1B • IL6

Safety and Efficacy of FSD201 for the Treatment of Chronic Pain Associated With Idiopathic MCAS (MCAD) (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: FSD Pharma, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Musculoskeletal Diseases • Pain • IL1B • IL6

Safety and Efficacy of FSD201 for the Treatment of Chronic Pain Associated With Idiopathic MCAS (MCAD) (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: FSD Pharma, Inc.

New P2 trial • Musculoskeletal Diseases • Pain • IL1B • IL6

Ultramicronized Palmitoylethanolamide (PEA) Treatment in Hospitalized Participants With COVID-19 (clinicaltrials.gov) - P2a | N=53 | Terminated | Sponsor: FSD Pharma, Inc. | N=350 ➔ 53 | Trial completion date: Dec 2021 ➔ Aug 2021 | Recruiting ➔ Terminated; Difficulties recruiting new subjects

Enrollment change • Trial completion date • Trial termination • Infectious Disease • Novel Coronavirus Disease

"$HUGE terminates Phase 2 trial of ultra-micronized palmitoylethanolamide ("PEA") or FSD-201, for use in treating COVID-19" (@BioStocks)

P2 data • Infectious Disease • Novel Coronavirus Disease

FSD Provides Corporate Update (Businesswire) - "The Company continues to pursue its strategy of completing a Phase 2 clinical trial for the use of its lead compound...to treat hospitalized COVID-19 patients in a double-blind study...Due to various factors, primarily relating to challenges with patient recruitment due to active COVID-19 pandemic-related restrictions in hospitals, the Company may not be in a position to complete the Study prior to the end of 2021....Company expects to require additional financing primarily to initiate another Phase 2 FDA approved study for its lead compound FSD 201 and to effectuate other potential in-licensing and acquisition opportunities."

Cytokine storm • Trial status • Infectious Disease • Novel Coronavirus Disease

FSD Pharma Announces First Patient Randomized in Phase 2 Trial of FSD201 for the Treatment of Hospitalized Patients with COVID-19 (Businesswire) - "The Company is expected to conduct this trial in 25-30 Medical Centers and Hospitals in North America; FSD Pharma Inc....today announced the dosing of the first patient in its Phase 2a clinical trial of FSD201 (ultramicronized palmitoylethanolamide, or ultramicronized PEA) for the treatment of hospitalized patients with COVID-19."

Cytokine storm • Trial status • Infectious Disease • Novel Coronavirus Disease

Ultramicronized Palmitoylethanolamide (PEA) Treatment in Hospitalized Participants With COVID-19 (clinicaltrials.gov) - P2a; N=350; Recruiting; Sponsor: FSD Pharma, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease • PCR

Ultramicronized Palmitoylethanolamide (PEA) Treatment in Hospitalized Participants With COVID-19 (clinicaltrials.gov) - P2a; N=350; Not yet recruiting; Sponsor: FSD Pharma, Inc.

Clinical • New P2a trial • Infectious Disease • Novel Coronavirus Disease • PCR

FSD Pharma Begins Phase 2 Clinical Trial to Evaluate FSD201 for the Treatment of Hospitalized COVID-19 Patients (Yahoo Finance) - "FSD Pharma Inc....today announced that the U.S. Food and Drug Administration ('FDA') has authorized the initiation of a Phase 2 study for the use of FSD201...to treat COVID-19, the disease caused by the SARS-CoV-2 virus (the 'FSD201 COVID-19 Trial'). The company is expected to start dosing patients in October 2020....The FSD201 COVID-19 Trial is a randomized, controlled, double-blind, multicenter study, conducted on 352 patients to assess the efficacy and safety of FSD201 dosed at 600mg or 1200mg twice-daily..."

Cytokine storm • New P2 trial • Infectious Disease • Novel Coronavirus Disease

FSD Pharma Announces Phase 2 Clinical Trial IND Filing With The FDA to Treat Patients With COVID-19 (Businesswire) - "FSD Pharma Inc....announced that it has submitted to the U.S. Food and Drug Administration ('FDA') an Investigational New Drug Application (IND) for the use of FSD201 (ultramicronized palmitoylethanolamide, or ultramicronized PEA) to treat COVID-19....The FSD201 COVID-19 Trial will be a randomized, controlled, double-blind, multicenter study, conducted at 25-30 sites in North America to assess the efficacy and safety of FSD201 dosed at 600mg or 1200mg twice-daily, together with standard of care..."

Cytokine storm • IND • New P2 trial • Infectious Disease • Novel Coronavirus Disease

FSD Pharma Reports Favorable Topline Results from Phase 1 First-in-Human Safety and Tolerability Study of Ultramicronized PEA (Businesswire) - P1, N=48; "FSD Pharma Inc....today announced favorable topline results from its Phase 1 randomized, double-blind, placebo-controlled study of ultramicronized palmitoylethanolamide (PEA), or FSD201....The study found ultramicronized PEA to be safe and well tolerated. Mild and self-limiting side effects were reported and were deemed unlikely to be related to study drug. There were no abnormal laboratory findings or ECGs observed during the study and no serious adverse events were reported....Our immediate plans for FSD201 include submitting these Phase 1 trial results for publication in a peer-reviewed journal and advancing this compound into a Phase 2a proof-of-concept trial for the treatment of COVID-19...'"

Cytokine storm • P1 data • Infectious Disease • Novel Coronavirus Disease

FSD Pharma receives U.S. FDA approval to design a phase 2a clinical trial to treat patients with suspected or confirmed Covid-19 diagnosis (Businesswire) - "FSD Pharma Inc....today announced that the U.S. Food and Drug Administration (FDA) has given the company permission to submit an Investigational New Drug Application (IND) for the use of FSD-201....FSD Pharma is focused on developing FSD-201 for its anti-inflammatory properties to avoid the cytokine storm....We expect the trial will be a randomized, controlled, double-blind, U.S. multicenter study."

Cytokine storm • IND • New P2a trial • Infectious Disease • Novel Coronavirus Disease