Quantum BioPharma Receives Ethics Committee Approval for Phase 2 Clinical Trial of FSD202 for Nociplastic Pain in Patients with Idiopathic Mast Cell Activation Syndrome

Rhea-AI Summary

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" ]

Positive

• None.

Negative

• 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

News Market Reaction – QNTM

+1.47%

1 alert

+1.47% News Effect

On the day this news was published, QNTM gained 1.47%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

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 20.11% (as of March 31, 2025) of Celly Nutrition at www.unbuzzd.com. The agreement with Celly Nutrition also includes royalty payments of 7% of sales from unbuzzd™ until payments to Quantum BioPharma total $250 million. Once $250 million is reached, the royalty drops to 3% in perpetuity. Quantum BioPharma retains 100% of the rights to develop similar products or alternative formulations specifically for pharmaceutical and medical uses. Quantum BioPharma maintains a portfolio of strategic investments through its wholly owned subsidiary, FSD Strategic Investments Inc., which represents loans secured by residential or commercial property.

For more information on Quantum BioPharma, please visit www.quantumbiopharma.com.

Forward-Looking Information

Certain information in this news release constitutes forward-looking statements under applicable securities laws. Any statements that are contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements are often identified by terms such as "may", "should", "anticipate", "expect", "potential", "believe", "intend" or the negative of these terms and similar expressions. Forward-looking statements in this news release include statements related to such.

Forward-looking information in this press release are based on certain assumptions and expected future events.

These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to additional information relating to Quantum BioPharma, including its annual information form, can be located on the SEDAR+ website at www.sedarplus.ca and on the EDGAR section of the United States Securities and Exchange Commission’s website at www.sec.gov for a more complete discussion of such risk factors and their potential effects.

Readers are cautioned that the foregoing list is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.

Forward-looking statements contained in this press release are expressly qualified by this cautionary statement and reflect the Company's expectations as of the date hereof and are subject to change thereafter. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events or results or otherwise or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law.

Contacts:

Quantum BioPharma Ltd.
Zeeshan Saeed, Founder, CEO and Executive Co-Chairman of the Board
Email: Zsaeed@quantumbiopharma.com  
Telephone: (833) 571-1811

Investor Relations
Investor Relations: IR@QuantumBioPharma.com  
General Inquiries: info@QuantumBioPharma.com   

FAQ

What is the purpose of Quantum BioPharma's (QNTM) Phase 2 trial for FSD202?

The trial aims to evaluate the safety and efficacy of FSD202 in treating chronic widespread musculoskeletal nociplastic pain in patients with Idiopathic Mast Cell Activation Syndrome (MCAS).

How many patients will be enrolled in QNTM's FSD202 Phase 2 trial?

The trial will enroll 60 patients who will receive either FSD202 or placebo twice daily for 56 consecutive days.

What is the primary endpoint of Quantum BioPharma's FSD202 Phase 2 trial?

The primary endpoint is measuring the decrease in average daily pain intensity from baseline to Day 28.

What is FSD202 and how does it work?

FSD202 is a drug product containing ultra-micronized palmitoylethanolamide (PEA), designed to address inflammatory diseases, particularly MCAS-related pain and inflammation.

What is the current treatment status for MCAS that QNTM's FSD202 aims to address?

Currently, there is no known cure for MCAS, and patients suffer from repeated anaphylactic symptoms and chronic pain, making new treatment options highly necessary.