Advos

Quantum BioPharma Advances Multiple Sclerosis Drug Development with Toxicity Studies

May 12th, 2025 1:05 PM
By: Advos Staff Reporter

Quantum BioPharma has completed critical toxicity studies for its lead multiple sclerosis drug candidate Lucid-21-302, positioning the company to submit an Investigational New Drug application to the FDA and potentially launch a Phase 2 clinical trial.

Quantum BioPharma Advances Multiple Sclerosis Drug Development with Toxicity Studies

Quantum BioPharma Ltd. has completed 90-day oral toxicity and toxicokinetic studies for its lead multiple sclerosis drug candidate Lucid-21-302, marking a significant milestone in the company's drug development process. The studies are designed to support the company's upcoming Investigational New Drug (IND) application to the U.S. Food and Drug Administration, which is expected to be submitted by the end of the year.

The research focuses on Lucid-21-302, a novel treatment designed to address multiple sclerosis by potentially preventing and reversing myelin degradation. Preclinical models have shown promising results, suggesting the drug could represent a first-in-class therapy for the neurological disorder.

These toxicity studies are crucial in the drug development pipeline, as they provide essential safety data required by regulatory agencies before human clinical trials can commence. The successful completion of these studies indicates that Lucid-21-302 has demonstrated acceptable safety profiles in laboratory testing, which is a critical step toward potential future clinical trials.

For patients and the medical community, this development represents a potential advancement in multiple sclerosis treatment. Multiple sclerosis is a complex neurological condition that currently lacks comprehensive curative treatments, making innovative approaches like Quantum BioPharma's research particularly significant.

The company's next step will be to submit the IND application to the FDA, which, if approved, would allow them to proceed with Phase 2 clinical trials. This progression could bring the potential treatment closer to becoming an available therapeutic option for multiple sclerosis patients.

Source Statement

This news article relied primarily on a press release disributed by InvestorBrandNetwork (IBN). You can read the source press release here,

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