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Quantum Biopharma signs agreement with manufacturer

By The Northwire Desk — AI Analysis Aug 11, 2025 · 17:12 QNTM · 36.95 Quantum Biopharma Ltd
QNTM · Price

Executive Summary

  • Quantum Biopharma Ltd. has signed an agreement with a leading contract development and manufacturing organization (CDMO) to manufacture an oral drug formulation of its potential breakthrough drug, Lucid-21-302 (Lucid-MS).
  • The oral formulation will serve as the drug product for the company's upcoming Phase 2 clinical trial, which aims to test the efficacy of Lucid-MS in helping patients regain mobility lost due to multiple sclerosis (MS).
  • This agreement marks a significant step in the clinical development of Lucid-MS as the company prepares its Investigational New Drug (IND) application with the FDA.

Key Details

  • Agreement Details: Quantum Biopharma, through its subsidiary Huge Biopharma Australia Pty. Ltd., entered into a manufacturing agreement with a leading CDMO.
  • Product: Oral drug formulation of Lucid-21-302 (Lucid-MS).
  • Indication: Multiple Sclerosis (MS), specifically targeting the restoration of mobility.
  • Clinical Stage: Preparation for an upcoming Phase 2 clinical trial.
  • Regulatory Status: The company is preparing an Investigational New Drug (IND) application with the FDA.
  • Drug Profile: Lucid-MS is described as a first-in-class, non-immunomodulatory, neuroprotective compound and a patented new chemical entity (NCE).
  • Preclinical Data: Animal models over the past decade have shown that Lucid-MS helps animals regain the ability to walk and prevents demyelination, a hallmark of MS and other neurodegenerative diseases.

Notable Quotes

  • "We are pleased to announce that we have signed this agreement with a leading CDMO to develop and manufacture an oral formulation of Lucid-MS. This marks an important step in the clinical development of Lucid-MS as we prepare the investigational new drug application with the FDA and prepare for our upcoming phase 2 trial of Lucid-21-302 in MS," said Dr. Andrzej Chruscinski, vice-president, scientific and clinical affairs, at Quantum Biopharma.
Read the original news release →

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