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Quantum Biopharma Announces That the Safety Review Committee Recommends Commencing Dosing of Second Cohort in the Phase 1 Multiple Ascending Dose Clinical Trial for Lucid-21-302 (Lucid-MS)

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Quantum BioPharma (NASDAQ: QNTM) announced that the safety review committee has recommended proceeding with the second cohort dosing in their Phase 1 Multiple Ascending Dose clinical trial for Lucid-21-302. The trial, conducted through subsidiary HUGE Biopharma Australia, is evaluating safety and pharmacokinetics of Lucid-21-302 in healthy adult participants. The recommendation follows a review of safety and pharmacokinetic data from the first cohort. The second cohort dosing is expected to begin within days.

Quantum BioPharma (NASDAQ: QNTM) ha annunciato che il comitato di revisione della sicurezza ha raccomandato di procedere con la somministrazione della seconda coorte nel loro studio clinico di Fase 1 su dosi ascendenti multiple per Lucid-21-302. Lo studio, condotto tramite la sussidiaria HUGE Biopharma Australia, sta valutando la sicurezza e la farmacocinetica di Lucid-21-302 in partecipanti adulti sani. La raccomandazione segue una revisione dei dati di sicurezza e farmacocinetica provenienti dalla prima coorte. La somministrazione della seconda coorte dovrebbe iniziare entro pochi giorni.

Quantum BioPharma (NASDAQ: QNTM) anunció que el comité de revisión de seguridad ha recomendado proceder con la dosificación de la segunda cohorte en su ensayo clínico de Fase 1 de dosis múltiples ascendentes para Lucid-21-302. El ensayo, realizado a través de su filial HUGE Biopharma Australia, está evaluando la seguridad y la farmacocinética de Lucid-21-302 en participantes adultos sanos. La recomendación sigue una revisión de los datos de seguridad y farmacocinética de la primera cohorte. Se espera que la dosificación de la segunda cohorte comience en pocos días.

퀀텀 바이오파마 (NASDAQ: QNTM)는 안전성 검토 위원이 루시드-21-302에 대한 1상 다중 증량 임상 시험의 두 번째 코호트 투여를 진행할 것을 추천했다고 발표했습니다. 이 시험은 HUGE 바이오파마 호주 자회사를 통해 수행되며, 건강한 성인 참가자를 대상으로 루시드-21-302의 안전성과 약리학적 특성을 평가하고 있습니다. 이 추천은 첫 번째 코호트의 안전성 및 약리학적 데이터 검토에 따라 이루어졌습니다. 두 번째 코호트의 투여는 며칠 내에 시작될 것으로 예상됩니다.

Quantum BioPharma (NASDAQ: QNTM) a annoncé que le comité de révision de sécurité a recommandé de procéder à l'administration de la deuxième cohorte dans leur essai clinique de Phase 1 sur des doses croissantes pour Lucid-21-302. L'essai, mené par la filiale HUGE Biopharma Australia, évalue la sécurité et la pharmacocinétique de Lucid-21-302 chez des participants adultes en bonne santé. La recommandation fait suite à un examen des données de sécurité et de pharmacocinétique de la première cohorte. L'administration de la deuxième cohorte devrait commencer d'ici quelques jours.

Quantum BioPharma (NASDAQ: QNTM) hat angekündigt, dass der Sicherheitsüberprüfungsausschuss empfohlen hat, mit der Dosierung der zweiten Kohorte in ihrer Phase-1-Studie zu mehreren aufeinanderfolgenden Dosen für Lucid-21-302 fortzufahren. Die Studie, die über die Tochtergesellschaft HUGE Biopharma Australia durchgeführt wird, bewertet die Sicherheit und Pharmakokinetik von Lucid-21-302 bei gesunden erwachsenen Teilnehmern. Die Empfehlung folgt auf eine Überprüfung der Sicherheits- und Pharmakokinetik-Daten aus der ersten Kohorte. Es wird erwartet, dass die Dosierung der zweiten Kohorte in den nächsten Tagen beginnt.

Positive
  • Safety review committee approved progression to second cohort, indicating positive safety profile from first cohort
  • Clinical trial advancing on schedule with next cohort starting within days
Negative
  • None.

Insights

This Phase 1 trial milestone for Lucid-21-302 represents a important development in Quantum BioPharma's multiple sclerosis program. The safety review committee's recommendation to proceed with the second cohort indicates a favorable initial safety profile in the first cohort, which is essential for early-stage drug development. Multiple ascending dose (MAD) studies are critical for understanding drug safety and pharmacokinetics across different dosage levels. The successful completion of the first cohort and progression to the second suggests the drug is being well-tolerated at initial doses. However, investors should note that Phase 1 trials primarily focus on safety rather than efficacy and multiple cohorts still need to be completed before moving to efficacy-focused Phase 2 trials. The structured, methodical approach with double-blind and placebo controls adds scientific rigor to the study design.

TORONTO, ON / ACCESSWIRE / December 10, 2024 / 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, HUGE Biopharma Australia Pty Ltd., that the safety review committee recommends commencing dosing of the second cohort in its trial entitled "A Phase 1, Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of Lucid-21-302 in Healthy Adult Participants." The safety review committee made this recommendation after reviewing safety and pharmacokinetic data from participants in the first cohort.

"Our clinical development team is delighted at the progress in this trial," said Dr. Andrzej Chruscinski, Vice-President, Scientific and Clinical Affairs at Quantum Biopharma. "We are thrilled that the safety review committee recommended to move forward with dosing of the next cohort, which is expected to commence in the next few days."

About Quantum BioPharma Ltd.

Quantum BioPharma 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 25.71% (as of June 30, 2024) 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. Additionally, Quantum BioPharma retains a large tax loss carry forward of approximately C$130 million and could be utilized in the future to offset tax payable obligations against future profits. Quantum BioPharma retains 100% of the rights to develop similar product 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.

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 relating to: the stated terms, use of proceeds, and timeline of the Offering; and the Company's issuance of the Debentures, Warrants (and the underlying Warrant Shares if exercised), and potential issuance of Shares (if the Debentures are converted).

Forward-looking information in this press release are based on certain assumptions and expected future events, including but not limited to: the Company has the ability to carry out the Offering as stated; and the Company has the ability to issue the Debentures, Warrants (and the underlying Warrant Shares if exercised), and Shares (if the Debentures are converted).

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: the Company's inability to carry out the Offering as stated; and the Company's inability to issue the Debentures, Warrants (and the underlying Warrant Shares if exercised), and Shares (if the Debentures are converted), as well the reader is urged to refer 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: (416) 854-8884
Investor Relations
Email: ir@quantumbiopharma.com, info@quantumbiopharma.com
Website: www.quantumbiopharma.com

SOURCE: Quantum Biopharma Ltd.



View the original press release on accesswire.com

FAQ

What is the status of Quantum BioPharma's Phase 1 trial for Lucid-21-302?

The safety review committee has recommended proceeding with second cohort dosing after reviewing safety data from the first cohort, with dosing expected to begin within days.

What type of clinical trial is QNTM conducting for Lucid-21-302?

QNTM is conducting a Phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate safety and pharmacokinetics in healthy adult participants.

When will Quantum BioPharma (QNTM) begin dosing the second cohort for Lucid-21-302?

According to the December 10, 2024 announcement, the second cohort dosing is expected to commence within the next few days.

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