Quantum BioPharma Ltd. (QNTM), a biopharmaceutical company, on Wednesday announced that it has submitted an Investigational New Drug IND application to the U.S. Food and Drug Administration FDA for Lucid-21-302, also known as Lucid-MS, its new drug candidate for the treatment of Multiple Sclerosis.
According to the firm, subject to FDA clearance, it intends to initiate the Phase 2 study, and the FDA response is anticipated in the second quarter of 2026.
Following the news, QNTM is up 5.95% at $5.12.
Multiple Sclerosis is characterised by unpredictable symptoms such as tingling sensations, vision problems, and mobility issues that are attributed to the patient's immune system attacking different nerve fibres.
Lucid-MS is designed to provide neuroprotection by inhibiting demyelination, a key driver of disease progression in Multiple Sclerosis.
The IND submission includes data from nonclinical pharmacology and toxicology studies, along with manufacturing and quality information, to support initiation of the planned Phase 2 clinical trial.
The planned Phase 2 trial will evaluate the efficacy, safety, and tolerability of Lucid-MS in people with Multiple Sclerosis.
In prior Phase 1 clinical trials, Lucid-MS demonstrated a favourable safety profile and was well tolerated in healthy participants, as reported in the clinical study report received through its subsidiary, Huge Biopharma Australia Pty Ltd.
Earlier in December 2025, the firm announced the completion of oral dosing in the 180-day toxicity and toxicokinetic studies for Lucid-21-30.
If everything goes well, the firm plans to initiate the Phase 2 trial in the second quarter, with data readout projected in the fourth quarter of 2026.
Multiple sclerosis affects approximately 2.8 million people worldwide (Source: pmc.ncbi.nlm.nih.gov), and, according to Grand View Research, the MS therapeutic market is projected to exceed $38 billion by 2030.
"We look forward to working with the FDA as we progress toward clinical evaluation of this novel approach to prevent disease progression in MS," said Dr. Andrzej Chruscinski, Vice-President, Scientific and Clinical Affairs at Quantum BioPharma.
QNTM has traded between $2.07 and $38.25 in the last year. The stock closed Tuesday's trade at $4.83.
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