FSD Pharma Signs the Agreement With iNGENu CRO To Conduct a Clinical Study To Assess the Safety and Pharmacokinetics of Multiple Ascending Doses of Lucid-21-302 (Lucid-MS) in Healthy Adults
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Insights
The initiation of a Phase 1 multiple ascending dose study for Lucid-21-302 by FSD Pharma represents a pivotal step in the drug development pipeline, particularly given the compound's novel approach to treating multiple sclerosis (MS). The focus on neuroprotection and demyelination prevention suggests a potential shift from the current immunomodulatory treatments that dominate the MS therapeutic market. This could have significant implications for market dynamics, as a successful drug in this category might not only expand treatment options but also disrupt existing market shares of established MS drugs.
From an investor's perspective, the progression to a new phase of clinical trials typically signals confidence in a compound's potential and can positively influence a company's valuation. However, it's important to note that drug development is inherently risky and the majority of compounds fail to make it to market. The safety and tolerability profile shown in the prior Phase 1 study is encouraging, yet efficacy data, which is critical for regulatory approval and market success, is still to be determined.
For stakeholders, the short-term benefits include the potential rise in stock value based on the optimism of the drug's prospects. Long-term, the success of Lucid-21-302 could lead to revenue generation and possibly a stronger competitive position for FSD Pharma within the biotech sector. However, the long and costly process of drug development, coupled with the uncertainty of clinical trial outcomes, presents a significant risk.
Lucid-21-302's non-immunomodulatory and neuroprotective characteristics are of particular interest in the field of MS research. The current landscape of MS treatments largely revolves around immunomodulatory agents that modify the immune system's response. A neuroprotective compound like Lucid-21-302 that targets demyelination independently of the immune system could offer a complementary or alternative therapeutic pathway. This is noteworthy because it addresses a different aspect of MS pathology, potentially leading to more comprehensive care for patients.
It's essential to consider the implications of a successful treatment on the patient population. If Lucid-21-302 proves to be effective, it could mean a significant improvement in quality of life for MS sufferers. This would not only be a win for patients but could also lead to increased demand for the drug and a positive reception from the medical community, which can greatly influence market uptake.
However, the current announcement relates only to safety and pharmacokinetics, which are preliminary but important steps in drug development. The efficacy, which will be evaluated in later-stage trials, will be the true test of the drug's potential impact on the market and the MS patient community.
The strategic collaboration with iNGENu CRO Pty Ltd for the clinical study of Lucid-21-302 is a significant business move for FSD Pharma. Partnering with a contract research organization (CRO) can accelerate the drug development process, reduce costs and provide access to specialized expertise. For investors, this partnership could signal a savvy approach to resource management and a commitment to advancing the company's pipeline efficiently.
Investment in biotech companies, especially those in the early stages of drug development, is often speculative. While the announcement of a new clinical trial phase can generate excitement and potentially increase investor interest, it is important to maintain a balanced view of the risks and timelines involved. The biotech sector is known for its volatility and the outcomes of clinical trials can have dramatic effects on a company's stock performance.
Looking at industry norms, the progression from a single ascending dose study to a multiple ascending dose study is a standard trajectory in drug development. However, the unique mechanism of action of Lucid-21-302, if proven effective, may set a new precedent in the treatment of neurodegenerative diseases, which could be a game-changer for FSD Pharma and its investors in the long run.
TORONTO, ON / ACCESSWIRE / March 27, 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 announced that through its subsidiary, HUGE Biopharma Australia Pty Ltd., it entered into agreement with iNGENu CRO Pty Ltd on March 26, 2024 to conduct "A Phase 1, Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of Lucid-21-302 in Healthy Adult Participants".
"We are very pleased to formalize this agreement and to collaborate with iNGENu to conduct this clinical study," said Zeeshan Saeed, Co-Chairman and CEO of FSD Pharma. "This clinical study builds on our prior Phase 1 study of Lucid-21-302 and represents an important next step in our mission to develop novel therapeutics for the treatment of MS."
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 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 a prior Phase 1 single ascending dose study, Lucid-21-302 was shown to be safe and well-tolerated in the dose range of 50-300 mg p.o. administered once to healthy adults, with no difference in pharmacokinetics between the fed and fasted states.
"Over the next several days and weeks, our R&D team will closely work with iNGENu to start this clinical study swiftly." added Dr. Andrzej Chruscinski, Vice-President, Scientific and Clinical Affairs at FSD Pharma. "We are very eager to complete this clinical trial as efficiently as possible, and are encouraged by the strong data from the prior Phase 1 single ascending dose study supporting the safety and tolerability of Lucid-21-302."
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.
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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.
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