FSD Pharma Submits a Phase-1 Multiple Ascending Doses Clinical Trial Application for Lucid-21-302 (Lucid-MS) for Ethics Committee Review in Australia

Rhea-AI Summary

FSD Pharma, a biopharmaceutical company, has submitted a Phase-1 clinical trial application for Lucid-21-302 in Australia. Lucid-21-302 is a neuroprotective compound for the treatment of multiple sclerosis, showing promise in preclinical models. The company aims to advance Lucid-21-302 into a phase-2 clinical trial, with optimism about its potential as a treatment for MS.

Positive

• Lucid-21-302 is a first-in-class, non-immunomodulatory, neuroprotective compound for the treatment of multiple sclerosis.

• Lucid-21-302 has shown promising results in preclinical models by preventing demyelination, a common issue in MS and other neurodegenerative diseases.

Negative

• None.

Medical Research Analyst

The progression of Lucid-21-302 from a Phase-1 single ascending dose (SAD) study to a Phase-1 multiple ascending dose (MAD) study is an encouraging development in the pursuit of new treatments for multiple sclerosis (MS). The compound's non-immunomodulatory, neuroprotective properties, combined with preclinical evidence suggesting its potential to prevent demyelination, present a novel approach to tackling a complex and debilitating disease. Given that safety and tolerability have been established at a certain dose range in a SAD study, the MAD study will further elucidate the compound's pharmacokinetic profile over repeated doses. This is a critical step towards the viability of Lucid-21-302 as a long-term treatment option. Investors should note that this is still early in the compound's development and while promising, the commercial viability, regulatory approval and market entrance are still several years away. Moreover, the MS treatment market is highly competitive with several established therapies and newcomers must demonstrate clear advantages in efficacy and safety to gain significant market share.

Biotech Patent Analyst

The mention of Lucid-21-302 as a patented New Chemical Entity (NCE) is significant from an intellectual property standpoint. Patent protection can provide a competitive edge in the biotech industry by securing exclusive rights to the commercialization of the compound. This exclusivity can result in a period of market monopoly post-regulatory approval, potentially leading to higher returns on investment. However, the patent landscape in the biotech sector can be complex and often crowded. Investors should consider the strength and breadth of the patent, as well as any existing or pending patents that might affect the compound's market position. The success of this compound will not only depend on its clinical efficacy but also on navigating the intellectual property environment effectively.

Market Research Analyst

Multiple sclerosis (MS) affects millions globally and advancements in treatment are closely watched by the market. The transition of Lucid-21-302 into further clinical trials positions FSD Pharma within a niche of neuroprotective treatments for MS, which is a significant market with unmet medical needs. The patient-centric approach and the potential of a non-immunomodulatory treatment could meet demands for alternatives to immunosuppressive therapies currently available. It's important for investors to monitor the patient and physician reception to new treatments, as well as payer willingness to cover new, potentially expensive therapies. Long-term investment consideration should also take into account potential partnership opportunities, market expansion and reimbursement strategies that FSD Pharma may adopt if Lucid-21-302 is proven successful in clinical trials.

TORONTO, ON / ACCESSWIRE / May 7, 2024 / FSD Pharma Inc. (NASDAQ:HUGE)(CSE:HUGE)(FRA:0K9A) ("FSD Pharma" or the "Company"), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions to address ailments affecting millions worldwide, today announces the submission to ethics of a trial entitled "A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of Lucid-21-302 in Healthy Adult Participants." This clinical trial application is submitted for review by a human ethics review committee (HREC) in Australia, a step that is necessary to obtain permission to initiate the multiple ascending dose (MAD) trial. The MAD trial follows the Phase-1 single ascending dose (SAD) trial that was recently completed.

Lucid-21-302 is a first-in-class, non-immunomodulatory, neuroprotective compound with a unique mechanism of action for the treatment of multiple sclerosis (MS). It is a patented New Chemical Entity that has been shown in preclinical models to prevent 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. In the prior Phase-1 single ascending dose (SAD) study, Lucid-21-302 was shown to be safe and well-tolerated in the dose range of 50-300 mg administered once orally to healthy adults, with no difference in pharmacokinetics between the fed and fasted states.

"We are eager to study multiple doses of Lucid-21-302 in healthy volunteers as this marks an important next step in advancing Lucid-21-302 into an optimally designed phase-2 clinical trial. We are very optimistic about the potential of Lucid-21-302 as a first-in-class, non-immunomodulatory treatment for MS as it progresses to the next phase of clinical development," said Dr. Andrzej Chruscinski, Vice-President, Scientific and Clinical Affairs at FSD Pharma.

About FSD Pharma

FSD Pharma is a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative and metabolic disorders and alcohol misuse disorders with drug candidates in different stages of development. Through its wholly-owned subsidiary, Lucid Psycheceuticals Inc. ("Lucid"), FSD is focused on the research and development of its lead compound, Lucid-MS (formerly Lucid-21-302) ("Lucid-MS"). Lucid-MS is a patented new chemical entity shown to prevent and reverse myelin degradation, the underlying mechanism of multiple sclerosis, in preclinical models. FSD Pharma has also licensed unbuzzd™, a proprietary formulation of natural ingredients, vitamins, and minerals to help with liver and brain function for the purposes of quickly relieving individuals from the effects of alcohol consumption for use in the consumer recreational sector, to Celly Nutrition Corp. ("Celly Nu") and is entitled to a royalty on the revenue generated by Celly Nu from sales of products created using the technology rights granted under the licensing agreement. FSD Pharma continues its R&D activities to develop novel formulations for alcohol misuse disorders and continues the development of such treatments for use in the healthcare sector. FSD maintains a portfolio of strategic investments through its wholly-owned subsidiary, FSD Strategic Investments Inc., which represent loans secured by residential or commercial property.

Cautionary Note Regarding Forward-Looking Information

This press release contains forward-looking statements and forward-looking information (collectively, "forward-looking statements") within the meaning of applicable securities laws. Any statements that are contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements are often identified by terms such as "plans", "expects", "expected", "scheduled", "estimates", "intends", "anticipates", "hopes", "planned" or "believes", or variations of such words and phrases, or states that certain actions, events or results "may", "could", "would", "might", "potentially" or "will" be taken, occur or be achieved. More particularly, and without limitation, this press release contains forward-looking statements contained in this press release include statements concerning the future of FSD Pharma and are based on certain assumptions that FSD Pharma has made in respect thereof as of the date of this press release, including those relating to future sales of Class B Shares under the ATM Offering, the offering price therefor and the use of proceeds thereof. FSD Pharma cannot give any assurance that such forward-looking statements will prove to have been correct.

Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. The Company cautions that although it believes the expectations and material factors and assumptions reflected in these forward-looking statements are reasonable as of the date hereof, there can be no assurance that these expectations, factors and assumptions will prove to be correct and these risks and uncertainties give rise to the possibility that actual results may differ materially from the expectations set out in the forward-looking statements. These forward-looking statements are not guarantees of future performance and are subject to a number of known and unknown risks and uncertainties including, but not limited to: the timing and ability to satisfy all applicable listing and regulatory requirements of the CSE and Nasdaq; the fact that the drug development efforts of the Company and Lucid are at a very early stage; the fact that preclinical drug development is uncertain, and the drug product candidates of the Company and Lucid may never advance to clinical trials; the fact that results of preclinical studies and early-stage clinical trials may not be predictive of the results of later stage clinical trials; the uncertain outcome, cost, and timing of product development activities, preclinical studies and clinical trials of the Company and Lucid; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; the potential inability to obtain or maintain regulatory approval of the drug product candidates of the Company and Lucid; the introduction of competing drugs that are safer, more effective or less expensive than, or otherwise superior to, the drug product candidates of the Company and Lucid; the initiation, conduct, and completion of preclinical studies and clinical trials may be delayed, adversely affected or impacted by unforeseen issues; the potential inability to obtain adequate financing; the potential inability to obtain or maintain intellectual property protection for the drug product candidates of the Company and Lucid; the inability of the Company to sell under the ATM Offering or upon the terms outlined herein; the prices at which the Company may sell the Class B Shares in the ATM Offering; and other risks. Accordingly, readers should not place undue reliance on the forward-looking statements contained in this press release, which speak only as of the date of this press release.

Further information regarding factors that may cause actual results to differ materially are included in the Company's annual and other reports filed from time to time with the Canadian Securities Administrators on SEDAR+ (www.sedarplus.ca) and with the SEC on EDGAR (www.sec.gov), including the Company's Annual Report on Form 20-F for the fiscal year ended December 31, 2022, the Prospectus and Registration Statement, each under the heading "Risk Factors". This list of risk factors should not be construed as exhaustive. Readers are cautioned that events or circumstances could cause results to differ materially from those predicted, forecasted or projected. The forward-looking statements contained in this document speak only as of the date of this document. FSD Pharma does not undertake any obligation to publicly update or revise any forward-looking statements or information contained herein, except as required by applicable laws. The forward-looking statements contained in this document are expressly qualified by this cautionary statement.

Neither the CSE nor its regulation services provider accept responsibility for the adequacy or accuracy of this release.

Contacts:

FSD Pharma Inc.
Zeeshan Saeed, Founder, CEO and Executive Co-Chairman of the Board, FSD Pharma Inc.
Email: Zsaeed@fsdpharma.com
Telephone: (416) 854-8884

Investor Relations
Email: ir@fsdpharma.com, info@fsdpharma.com
Website: www.fsdpharma.com

SOURCE: FSD Pharma Inc.

View the original press release on accesswire.com

FAQ

What is the focus of FSD Pharma's Phase-1 clinical trial application for Lucid-21-302?

FSD Pharma's Phase-1 clinical trial application for Lucid-21-302 in Australia focuses on evaluating the safety and pharmacokinetics of the neuroprotective compound in healthy adult participants.

What is Lucid-21-302 and its potential treatment application?

Lucid-21-302 is a first-in-class, non-immunomodulatory compound aimed at treating multiple sclerosis by preventing demyelination, a common issue in MS and other neurodegenerative diseases.

Who announced the submission of the clinical trial application for Lucid-21-302?

FSD Pharma announced the submission of the clinical trial application for Lucid-21-302 in Australia.

What are the results of the Phase-1 single ascending dose study of Lucid-21-302?

The Phase-1 single ascending dose study of Lucid-21-302 demonstrated its safety and tolerability in healthy adults, paving the way for further clinical development.

What is the next step for Lucid-21-302 after the Phase-1 clinical trial application?

FSD Pharma aims to advance Lucid-21-302 into an optimally designed phase-2 clinical trial following the Phase-1 clinical trial application submission.