- FSD Pharma (CSE:HUGE) reveals it has submitted to the ethics review committee in Australia a Phase-1 Multiple Ascending Doses Clinical Trial Application for Lucid-21-302 MS treatment
- The application is a crucial step necessary for permission to initiate the multiple ascending dose trial
- The MAD trial follows the Phase 1 single dose trial recently completed by the company
- Shares of FSD Pharma are unchanged at C$0.52
FSD Pharma (CSE:HUGE) has revealed it has submitted a Phase-1 Multiple Ascending Doses Clinical Trial Application for Lucid-21-302 MS treatment to the ethics review committee in Australia.
In a news release, the Toronto-based company stated its application is a crucial step necessary for permission to initiate the multiple ascending dose (MAD) trial, which will follow the Phase 1 single-dose trial recently completed by FSD Pharma.
The MAD trial follows the Phase 1 single dose trial recently completed by the company.
“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,” Andrzej Chruscinksi, vice president of scientific and clinical affairs at FSD Pharma, said in a statement. “We are very optimistic about the potential of Lucid-21-302 as a first-in-class, non-immunomodulatory treatment for (multiple sclerosis) as it progresses to the next phase of clinical development.”
Lucid-21-302 is a first-in-class, non-immunomodulatory, neuroprotective compound with a unique mechanism of action to treat multiple sclerosis (MS).
It is a patented New Chemical Entity that has been shown in preclinical models to prevent demyelination, a cause of MS and other neurogenerative diseases characterized by damage to the myelin sheath surrounding nerve fibers in the central nervous system.
In a previous Phase-1 single ascending dose study, Lucid-21-302 was proven to be safe and well-tolerated in healthy adults who took a dose range of 50-300 mg once orally.
FSD Pharma is a biopharmaceutical company that operates through two segments: biotechnology and strategic investments.
Its biotechnology segment is focused on furthering the research and development of FSD Pharma’s two primary drug candidates consisting of Lucid-MS and Lucid-PSYCH, as well as the development of UNBUZZD.
Shares of FSD Pharma Inc. (CSE:HUGE) are unchanged at C$0.52.
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