InvestmentPitch Media Video Discusses FSD Pharma’s Receipt of No Objection Letter from Health Canada for Clinical Trials for LUCID-21-302 for MS

Rhea-AI Summary

FSD Pharma announced the receipt of a No Objection Letter from Health Canada for its proposed Phase 1 clinical trial of LUCID-21-302 (Lucid-MS), aimed at treating Multiple Sclerosis. This approval allows the company to advance its clinical investigations in Canada. Lucid-MS has undergone over 11 years of R&D and is noted for its neuroprotective properties without immunomodulatory effects. The global Multiple Sclerosis market is expected to grow from $22.99 billion in 2018 to $28.0 billion by 2026. Currently, FSD Pharma shares trade at US $1.38.

Positive

• Received No Objection Letter from Health Canada for Phase 1 clinical trial of Lucid-MS.
• Lucid-MS is a unique neuroprotective drug candidate with over 11 years of R&D.
• Demonstrated capability to prevent myelin degradation and promote recovery in preclinical models.

Negative

• None.

VANCOUVER, British Columbia, Feb. 09, 2023 (GLOBE NEWSWIRE) -- FSD Pharma Inc. (NASDAQ:HUGE) (CSE:HUGE) (FSE:0K9A), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative, inflammatory and metabolic disorders, has received a No Objection Letter from Health Canada. The Letter of No Objection covers the company’s proposed Phase 1 clinical trial of LUCID-21-302 or Lucid-MS, a novel drug candidate for the treatment of Multiple Sclerosis and provides FSD Pharma with regulatory approval to move forward with the clinical trial in Canada.

A Media Snippet accompanying this announcement is available by clicking on the image or link below:

For more information, please view the InvestmentPitch Media video which provides additional information about this news and the company. The video is available for viewing on “InvestmentPitch” and on “YouTube”. If these links are not enabled, please visit www.InvestmentPitch.com and enter “FSD Pharma” in the search box.

The first-in-human clinical trial will evaluate the safety and tolerability of Lucid-MS, a neuroprotective compound with a unique mechanism of action for the treatment of MS, which currently has no cure.

Lucid-MS is a patented New Chemical Entity or “NCE” that has been the subject of more than 11 years of research and development. In preclinical models, Lucid-MS has been shown to prevent myelin degradation (demyelination), a known cause of MS and other neurogenerative diseases characterized by damage to the myelin sheath surrounding nerve fibers in the central nervous system. Preclinical evidence has demonstrated Lucid-MS to promote functional recovery in experimental animal models of MS. Based upon current evidence, Lucid-MS is non-immunomodulatory, an important distinction in the potential for developing new, safe options for treating MS.

Dr. Lakshmi Kotra, CEO of Lucid Psycheceuticals, a wholly owned subsidiary of FSD Pharma, stated: “There is an acute need today for effective, non-immunomodulatory, neuroprotective therapeutics, especially for the treatment of progressive stages of MS. We are excited to receive the NOL regulatory clearance, and look forward to initiating the first clinical trial of this promising candidate as a critical steppingstone in our mission to develop novel therapeutics for the treatment of MS. We will continue to work with Health Canada and other regulators worldwide to complete clinical investigations as soon as we can.”

Dr. Andrzej Chruscinski, Vice-President, Clinical and Scientific Affairs at Lucid Psycheceuticals, added: “Our drug development team worked hard to advance this pipeline into clinical stages. We continue to evaluate our clinical development strategy to advance Lucid-MS into next phases of development efficiently in collaboration with our expert advisors.”

According to the MS International Foundation, the number of people diagnosed worldwide with Multiple Sclerosis in 2020 is estimated at 2.8 million, up significantly from 2.3 million in 2013, with the U.S. and Canada ranking amongst the highest in the world in prevalence per capita, with 288 cases per 100,000 people and 250 cases per 100,000 people, respectively. MS can occur at any age, with at least 30,000 children under the age of 18 living with the disease and 32 being the average age globally. It is far more frequent in females (69% of cases) than in males (31% of cases). According to Allied Market Research, the global MS therapies market was valued at $22.99 billion in 2018 and will grow at a 2.5% compound annual growth rate to reach $28.0 billion by 2026

FSD Pharma Inc., through two wholly owned subsidiaries, has three drug candidates in different stages of development. FSD BioSciences is focused on pharmaceutical research and development of its lead compound, FSD201, a proprietary ultra-micronized PEA formulation, for the treatment of inflammatory diseases. In addition to Lucid-MS, Lucid Psycheceuticals is also focused on the development of Lucid-Psych a molecular compound identified for the potential treatment of mental health disorders, and expanding this category, the company is investigating other products addressing acute medical needs due to the abuse of drugs such as alcohol.

The shares are trading at US $1.38 on NASDAQ. For more information on the company’s drug candidates, please visit the company’s website, www.FSDpharma.com, or contact Zeeshan Saeed, Founder, President and Executive Co-Chairman, at 416-854-8884 or email zsaeed@FSDPharma.com or IR@FSDPharma.com.

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FAQ

What is the significance of the No Objection Letter from Health Canada for HUGE?

The No Objection Letter allows FSD Pharma to commence their Phase 1 clinical trial of Lucid-MS, a key step in drug development.

When will the Phase 1 clinical trial for Lucid-MS begin?

The company plans to initiate the Phase 1 clinical trial as soon as possible after receiving regulatory clearance.

What are the expected market trends for Multiple Sclerosis therapies?

The market for Multiple Sclerosis therapies is projected to grow from $22.99 billion in 2018 to $28.0 billion by 2026.

What are the main therapeutic properties of Lucid-MS?

Lucid-MS is a neuroprotective candidate that prevents myelin degradation without immunomodulatory effects.

What does the Phase 1 trial for Lucid-MS evaluate?

The Phase 1 trial will evaluate the safety and tolerability of Lucid-MS in human subjects.