FSD Pharma Submits Phase-1 Trial Application for Lucid-MS in Australia

FSD Pharma Inc., a biopharmaceutical company specializing in innovative biotech solutions for critical health ailments, has announced the submission of a clinical trial for Lucid-21-302 to an ethics review committee in Australia. This submission is a pivotal step towards conducting a multiple ascending dose (MAD) trial. The upcoming trial builds on the success of the previously completed Phase-1 single ascending dose (SAD) trial.

Lucid-21-302 is a groundbreaking neuroprotective compound designed for treating multiple sclerosis (MS). Unlike traditional immunomodulatory treatments, this compound operates through a unique mechanism that specifically targets the prevention of demyelination. Demyelination, the deterioration of the myelin sheath surrounding nerve fibers, is a principal cause of MS and other neurodegenerative diseases. The compound, classified as a New Chemical Entity, has shown promising results in preclinical models by effectively preventing this degeneration.

The Phase-1 SAD trial demonstrated that Lucid-21-302 is safe and well-tolerated in doses ranging from 50 to 300 mg when administered orally to healthy adults. Additionally, there was no observed difference in the pharmacokinetics of the drug between fed and fasting states.

Dr. Andrzej Chruscinski, Vice-President of Scientific and Clinical Affairs at FSD Pharma, expressed enthusiasm about advancing to the next phase of clinical development. He highlighted the potential of Lucid-21-302 as a first-in-class treatment for MS that does not rely on immunomodulation. The forthcoming MAD trial will provide further insights necessary for designing an optimal Phase-2 clinical trial.

FSD Pharma is committed to developing a range of biotech solutions aimed at treating challenging neurodegenerative and metabolic disorders, as well as alcohol misuse. The company operates through its subsidiary, Lucid Psycheceuticals Inc., with Lucid-MS (formerly Lucid-21-302) as its leading compound. Preclinical studies have shown that Lucid-MS can prevent and even reverse myelin degradation, offering hope for those suffering from MS.

In addition to its work on neuroprotective compounds, FSD Pharma has licensed unbuzzd™, a mixture of natural ingredients, vitamins, and minerals designed to support liver and brain function and alleviate the effects of alcohol consumption. This product is marketed in the consumer recreational sector by Celly Nutrition Corp., with FSD Pharma earning royalties from the sales generated.

FSD Pharma continues to invest in research and development to create innovative treatments for alcohol misuse disorders and other health issues. The company also manages a portfolio of strategic investments through its subsidiary, FSD Strategic Investments Inc., focusing on loans secured by residential or commercial properties.

In summary, FSD Pharma is making significant strides in the biopharmaceutical field with its cutting-edge research and development efforts. The upcoming clinical trial for Lucid-21-302 represents a crucial step in addressing multiple sclerosis, potentially offering a novel treatment option for this debilitating disease.