Quantum BioPharma Receives Ethics Committee Approval for Phase 2 Clinical Trial of FSD202 for Nociplastic Pain in Patients with Idiopathic Mast Cell Activation Syndrome
Quantum BioPharma (NASDAQ: QNTM) has received Human Ethics Review Committee approval in Australia for a Phase 2 clinical trial of FSD202, targeting nociplastic pain in patients with Idiopathic Mast Cell Activation Syndrome (MCAS). The trial will be a randomized, double-blind, placebo-controlled study involving 60 patients who will receive either FSD202 or placebo twice daily for 56 days.
The study's primary endpoint is measuring the decrease in average daily pain intensity from baseline to Day 28. FSD202, containing ultra-micronized palmitoylethanolamide (PEA), aims to address inflammatory diseases, particularly MCAS, which causes multisystem symptoms and chronic widespread musculoskeletal pain. Currently, MCAS has no known cure, and patients suffer from repeated anaphylactic symptoms and chronic pain.
[ "Phase 2 trial approval received from ethics committee, advancing clinical development pipeline", "Trial targets MCAS, which currently has no cure, representing a significant market opportunity", "FSD202 has potential applications beyond MCAS in other inflammatory diseases", "Well-designed trial with clear endpoints and controlled study parameters" ]Quantum BioPharma (NASDAQ: QNTM) ha ottenuto l'approvazione dal Comitato Etico per la Revisione Umana in Australia per una sperimentazione clinica di Fase 2 su FSD202, mirata al dolore nociplastico nei pazienti con Sindrome da Attivazione Mastocitaria Idiopatica (MCAS). Lo studio sarà uno studio randomizzato, in doppio cieco e controllato con placebo che coinvolgerà 60 pazienti, i quali riceveranno FSD202 o placebo due volte al giorno per 56 giorni.
L'obiettivo principale dello studio è misurare la riduzione dell'intensità media del dolore giornaliero dalla baseline al Giorno 28. FSD202, contenente palmitoiletanolamide (PEA) ultra-micronizzata, punta a trattare malattie infiammatorie, in particolare la MCAS, che provoca sintomi multisistemici e dolore muscoloscheletrico cronico diffuso. Attualmente, la MCAS non ha una cura nota e i pazienti soffrono di sintomi anafilattici ricorrenti e dolore cronico.
Quantum BioPharma (NASDAQ: QNTM) ha recibido la aprobación del Comité de Ética en Australia para un ensayo clínico de Fase 2 de FSD202, dirigido al dolor nociplástico en pacientes con Síndrome de Activación de Mastocitos Idiopático (MCAS). El ensayo será un estudio aleatorizado, doble ciego y controlado con placebo que incluirá a 60 pacientes que recibirán FSD202 o placebo dos veces al día durante 56 días.
El objetivo principal del estudio es medir la disminución de la intensidad media diaria del dolor desde el inicio hasta el Día 28. FSD202, que contiene palmitoiletanolamida (PEA) ultra-micronizada, busca tratar enfermedades inflamatorias, especialmente MCAS, que provoca síntomas multisistémicos y dolor musculoesquelético crónico generalizado. Actualmente, MCAS no tiene cura conocida y los pacientes sufren síntomas anafilácticos recurrentes y dolor crónico.
Quantum BioPharma (NASDAQ: QNTM)는 호주 인체 윤리 심의위원회로부터 특발성 비만세포 활성화 증후군(MCAS) 환자의 통증 완화를 목표로 하는 FSD202의 2상 임상시험 승인을 받았습니다. 이 임상시험은 무작위 배정, 이중 맹검, 위약 대조 연구로 60명의 환자가 56일 동안 하루 두 번 FSD202 또는 위약을 투여받게 됩니다.
연구의 주요 목표는 기저선부터 28일까지 일일 평균 통증 강도의 감소를 측정하는 것입니다. 초미세화된 팔미토일에탄올아마이드(PEA)를 함유한 FSD202는 염증성 질환, 특히 다기관 증상과 만성 광범위 근골격계 통증을 유발하는 MCAS 치료를 목표로 합니다. 현재 MCAS는 알려진 치료법이 없으며, 환자들은 반복적인 아나필락시스 증상과 만성 통증에 시달리고 있습니다.
Quantum BioPharma (NASDAQ: QNTM) a obtenu l'approbation du comité d'éthique humaine en Australie pour un essai clinique de phase 2 de FSD202, ciblant la douleur nociplastique chez les patients atteints du syndrome d'activation mastocytaire idiopathique (MCAS). L'essai sera une étude randomisée, en double aveugle, contrôlée par placebo impliquant 60 patients qui recevront soit FSD202, soit un placebo deux fois par jour pendant 56 jours.
L'objectif principal de l'étude est de mesurer la diminution de l'intensité moyenne quotidienne de la douleur entre le début et le jour 28. FSD202, contenant de la palmitoyléthanolamide (PEA) ultra-micronisée, vise à traiter les maladies inflammatoires, en particulier le MCAS, qui provoque des symptômes multisystémiques et des douleurs musculo-squelettiques chroniques étendues. Actuellement, le MCAS n'a pas de traitement connu, et les patients souffrent de symptômes anaphylactiques récurrents et de douleurs chroniques.
Quantum BioPharma (NASDAQ: QNTM) hat die Genehmigung des Human Ethics Review Committee in Australien für eine Phase-2-Studie mit FSD202 erhalten, die auf nociplastische Schmerzen bei Patienten mit idiopathischem Mastzellaktivierungssyndrom (MCAS) abzielt. Die Studie wird eine randomisierte, doppelblinde, placebokontrollierte Studie sein, an der 60 Patienten teilnehmen, die entweder FSD202 oder Placebo zweimal täglich über 56 Tage erhalten.
Der primäre Endpunkt der Studie ist die Messung der Verringerung der durchschnittlichen täglichen Schmerzintensität von der Baseline bis Tag 28. FSD202, das ultramikronisiertes Palmitoylethanolamid (PEA) enthält, zielt darauf ab, entzündliche Erkrankungen, insbesondere MCAS, zu behandeln, die multisystemische Symptome und chronische, weit verbreitete muskuloskelettale Schmerzen verursacht. Derzeit gibt es keine bekannte Heilung für MCAS, und die Patienten leiden unter wiederkehrenden anaphylaktischen Symptomen und chronischen Schmerzen.
- None.
- Small trial size of only 60 patients may limit statistical significance
- Relatively long treatment duration of 56 days could impact patient retention
- Unknown timeline for potential commercialization
- No preliminary efficacy data available yet
Insights
Quantum's Phase 2 trial approval for FSD202 represents regulatory progress for their lead candidate in MCAS pain, but remains early-stage with efficacy unproven.
Quantum BioPharma has secured a critical regulatory milestone with Human Ethics Review Committee approval in Australia for their Phase 2 clinical trial of FSD202. This 60-patient randomized study will evaluate ultra-micronized palmitoylethanolamide (PEA) for nociplastic pain in patients with idiopathic Mast Cell Activation Syndrome (MCAS).
This trial represents moderate progression in Quantum's clinical pipeline, moving from preclinical to efficacy-focused human testing. The double-blind, placebo-controlled design is scientifically robust, with the primary endpoint measuring pain intensity reduction at 28 days. However, investors should note this remains an early-stage clinical program with efficacy yet unproven.
MCAS represents a strategic indication choice - a condition with no current cure and substantial unmet medical need. The therapeutic target (nociplastic pain) also opens potential applications across multiple inflammatory conditions. If successful, FSD202 could address a substantial market spanning chronic inflammatory diseases, which the WHO identifies as a major global health threat.
While ethics approval enables trial initiation, several critical uncertainties remain: the timeline for first patient enrollment, study completion targets, and when efficacy results might be available. The 56-day treatment duration suggests data could emerge relatively quickly compared to longer-term studies, but no specific timeline was provided. The primary endpoint at day 28 will be the first critical efficacy indicator to watch.
TORONTO, May 28, 2025 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (“Quantum BioPharma” or the “Company”), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions, today announces through its subsidiary, FSD Pharma Australia Pty Ltd., that it has received approval by the human ethics review committee (HREC) in Australia for its trial entitled “A Randomized, Double-Blind Placebo Controlled Parallel Group Decentralized Trial to Assess the Safety and Efficacy of FSD202 in Participants with Chronic Widespread Musculoskeletal Nociplastic Pain Associated with Idiopathic Mast Cell Activation Syndrome (Disorder).”
The randomized, double-blind, placebo controlled parallel group decentralized trial will enroll 60 patients with idiopathic Mast Cell Activation Syndrome (“MCAS”). Per the protocol, patients will receive FSD202 or placebo twice daily for 56 consecutive days. The primary outcome to be measured will be the decrease from baseline to Day 28 in the average daily pain intensity. The trial will also evaluate many secondary outcomes. MCAS refers to a group of disorders characterized by multisystem symptoms resulting from the accumulation of altered mast cells and/or abnormal mast cell mediator release, causing repeated anaphylactic symptoms/episodes and trapping a patient in a cycle of neurogenic pain and inflammation. Chronic widespread musculoskeletal nociplastic pain, a type of chronic pain characterized by altered pain perception that is not directly due to tissue injury, is associated with MCAS. The cause of MCAS is unknown and there currently is no cure.
FSD202, a drug product containing ultra-micronized palmitoylethanolamide (PEA), has the potential to address a wide range of inflammatory diseases in addition to MCAS. This is especially important as chronic inflammatory diseases are the most significant cause of death globally and the World Health Organization ranks chronic disease as the greatest threat to human health.1
“We are excited to evaluate the efficacy and safety of FSD202 in a Phase 2 trial for the treatment of nociplastic pain associated with idiopathic MCAS. These patients often have a significantly reduced quality of life and are in desperate need of safe alternatives to the current standard of care,” said Dr. Andrzej Chruscinski, Vice-President, Scientific and Clinical Affairs at Quantum Biopharma.
Zeeshan Saeed, CEO of Quantum BioPharma added, “We are delighted to receive HREC approval to proceed with our planned efficacy Phase 2 clinical trial of FSD202. Our clinical team has worked tirelessly to develop the clinical trial protocol and we are now looking forward to the next stages of clinical development for FSD202.”
1Chronic Inflammation - StatPearls - NCBI Bookshelf (nih.gov); https://www.ncbi.nlm.nih.gov/books/NBK493173/
About Quantum BioPharma Ltd.
Quantum BioPharma (NASDAQ: QNTM) is a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative and metabolic disorders and alcohol misuse disorders with drug candidates in different stages of development. Through its wholly owned subsidiary, Lucid Psycheceuticals Inc. (“Lucid”), Quantum BioPharma is focused on the research and development of its lead compound, Lucid-MS. Lucid-MS is a patented new chemical entity shown to prevent and reverse myelin degradation, the underlying mechanism of multiple sclerosis, in preclinical models. Quantum BioPharma invented unbuzzd™ and spun out its OTC version to a company, Celly Nutrition Corp. (“Celly Nutrition”), led by industry veterans. Quantum BioPharma retains ownership of
For more information on Quantum BioPharma, please visit www.quantumbiopharma.com.
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Contacts:
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Zeeshan Saeed, Founder, CEO and Executive Co-Chairman of the Board
Email: Zsaeed@quantumbiopharma.com
Telephone: (833) 571-1811
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FAQ
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