LUCID-MS / Quantum BioPharma - LARVOL DELTA

Quantum BioPharma Submits its Candidate Breakthrough Patented Drug for Multiple Sclerosis for Fast-Track Program in the United Kingdom (Yahoo Finance) - "Quantum BioPharma Ltd...announces through its subsidiary, Huge Biopharma Australia Pty Ltd., the submission of its patented candidate breakthrough drug, Lucid-21-302 (Lucid-MS), to the Innovative Licensing and Access Pathway (ILAP) Passport program in the United Kingdom (UK). The ILAP Passport application was submitted for Lucid-21-302 as a new, first-in-class treatment for multiple sclerosis (MS)."

Commercial • Multiple Sclerosis

Quantum Biopharma Announces Signing of an Agreement with a Global Pharmaceutical Contract Research Organization to Prepare an IND (Investigational New Drug) Application Package for Lucid-21-302 (Lucid-MS), A First-In-Class Treatment for Multiple Sclerosis (Yahoo Finance) - "Quantum BioPharma Ltd...announces that it has signed an agreement with a global pharmaceutical contract research organization to prepare an IND (Investigational New Drug) application package for Lucid-21-302 (Lucid-MS) with the US FDA. A successful IND application will allow Quantum Biopharma to move forward with a Phase 2 trial of Lucid-21-302 in people with multiple sclerosis (MS)....'We are pleased to announce that we have signed this agreement to prepare the IND application package, which we hope to submit to the FDA in Q4 2025. This agreement takes us a step closer to initiating the phase 2 trial of Lucid-21-302, a first-in-class treatment for MS'"

IND • New P2 trial • Multiple Sclerosis

Quantum BioPharma Announces Completion of Dosing in 90-Day Repeated Dose Oral Toxicity and Toxicokinetic Studies for Lucid-MS for Multiple Sclerosis (GlobeNewswire) - "Quantum BioPharma Ltd...today announced that dosing of drug has completed in 90-day oral toxicity and toxicokinetic studies for Lucid-21-302 (Lucid-MS) for Multiple Sclerosis ('MS'). These studies were commissioned to provide data to support an IND application with the US FDA....Reports from these studies will support an IND application, which we hope to submit before the end of the year....By completing these toxicity studies, we are now closer to initiating a Phase 2 trial of Lucid-21-302 in people with MS."

IND • New P2 trial • Trial status • Multiple Sclerosis

Evaluating the Safety and Pharmacokinetics of Multiple Ascending Doses of Lucid-21-302 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Huge Biopharma Australia Pty Ltd | Recruiting ➔ Completed

Trial completion

Quantum Biopharma Announces Completion of the Phase 1 Multiple Ascending Dose Clinical Trial for its Experimental Multiple Sclerosis Drug Lucid-21-302 (GlobeNewswire) - "Quantum BioPharma Ltd...announced that it has completed its trial...A final safety review committee ('SRC') meeting was held after completion of the trial. The SRC found that Lucid-21-302 ('Lucid-MS') was well-tolerated with no safety concerns and no serious adverse events were reported during the trial."

DSMB • Trial completion • Multiple Sclerosis

Evaluating the Safety and Pharmacokinetics of Multiple Ascending Doses of Lucid-21-302 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Quantum Biopharma | Not yet recruiting ➔ Recruiting

Enrollment open

Evaluating the Safety and Pharmacokinetics of Multiple Ascending Doses of Lucid-21-302 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: FSD Pharma, Inc.

New P1 trial

Lucid-21-302 (Lucid-MS) for Protecting Myelin and Neurons and Preventing Disease Progression in Multiple Sclerosis: First-In-Human Phase-1 Dose Escalation Study in Healthy Volunteers (ACTRIMS Forum 2024) - "Lucid-21-302 (Lucid-MS) is safe and well-tolerated in the dose range of 50-300 mg p.o. administered once, with no difference in pharmacokinetics between the fed and fasted states. Compound exposure (AUC) in humans (300 mg) was comparable to that observed in mice at efficacious doses (50 mg/kg). Preclinical studies suggested that potential efficacious dose in humans (250-300 mg) is 7-fold and 9-fold lower than NOAEL in dogs and rats, respectively."

Clinical • P1 data • CNS Disorders • Multiple Sclerosis

A Randomized, Double-Blind, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Lucid-21-302 in Healthy Volunteers (NCT05821387): A potential candidate targeting demyelination (MSMilan 2023) - P1 | No abstract available

Clinical • Late-breaking abstract • PK/PD data

Evaluating the Safety, Tolerability, Pharmacokinetics, and Effect of Food of Lucid-21-302 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: FSD Pharma, Inc. | Recruiting ➔ Completed

Trial completion

FSD Pharma Completes Dosing of First Cohort in Phase I Clinical Trial of Lucid-MS, a New Drug Candidate for the Treatment of Multiple Sclerosis: Safety Review Committee Recommends Commencing Dosing of Second Cohort (Businesswire) - "FSD Pharma Inc...announced the completion of dosing the first cohort of patients in the Company’s Phase I clinical trial of Lucid-21-302...being conducted by FSD Pharma through the Company’s wholly owned subsidiary Lucid Psycheceuticals, is a first-in-human study evaluating Lucid-MS, a small molecule inhibitor of hypercitrullination, as a novel drug candidate for the treatment of Multiple Sclerosis....Enrollment will be comprised of five SAD cohorts and two MAD cohorts. Each SAD and MAD cohort will enroll eight participants (for a total of 56 participants) randomized to six active and two placebo groups. Participants in the active group will receive single or multiple doses of Lucid-MS. For the SAD cohort with food effect, all eight participants will receive Lucid-MS."

Trial status • Immunology • Multiple Sclerosis

Evaluating the Safety, Tolerability, Pharmacokinetics, and Effect of Food of Lucid-21-302 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: FSD Pharma, Inc.

New P1 trial

FSD Pharma Achieves Milestone in Completion of Dosing of Sentinel Subjects in First-in-Human Clinical Trial of Lucid-MS (Lucid-21-302) for Multiple Sclerosis (Businesswire) - "FSD Pharma...today announced completion of the first-in-human ('FIH') sentinel dosing of Lucid-21-302 ('Lucid-MS') in the Company’s Phase I clinical trial evaluating its novel drug candidate as an orally-administered treatment for Multiple Sclerosis ('MS'). The sentinel dose was completed on Sunday, April 16, 2023."

Trial status • CNS Disorders • Immunology • Multiple Sclerosis