FSD Pharma (CSE:HUGE, NASDAQ:HUGE) Inc announced that its wholly-owned Lucid Psycheceuticals Inc subsidiary has filed a provisional patent application on novel formulations of palmitoylethanolamide (PEA).
The Toronto-based biotechnology company said the new patent application is based on the results of completed preclinical animal toxicology studies and phase 1 clinical trial using FSD201 (ultramicronized PEA), sponsored by FSD Pharma (CSE:HUGE, NASDAQ:HUGE).
“New patent applications are a critical step for protecting our assets in the development of effective therapeutics targeting brain and inflammatory disorders,” Lucid Psycheceuticals CEO Dr Lakshmi Kotra said in a statement.
READ: FSD Pharma submits IND applications to FDA and Health Canada for Phase 2 clinical trial of FSD-201 to treat an inflammatory disorder
“Novel, high-quality treatments and intellectual property are important to us as an innovation-driven company, and I am very pleased with our team’s performance to stay on target towards the key milestones in 2022, including the planned Phase 2 trial of FSD201,” Kotra added.
FSD Pharma noted it is diligently pursuing the clinical development of FSD201 for various indications, including its previously-announced submission of an Investigational New Drug application with the US Food and Drug Administration (FDA) and Health Canada detailing a planned Phase 2 clinical trial of FSD201 for the treatment of a yet-to-be-disclosed inflammatory disorder.
The company added that it is fortifying its intellectual property position through additional novel formulations using PEA with superior biopharmaceutical profiles to serve patients in need.
As well, FSD Pharma reported that it presented its preclinical toxicology results on FSD201 at the 32nd Annual Symposium of the International Cannabinoid Research Society held in Galway, Ireland on June 25-30, 2022, in a scientific peer setting.
The poster presentation titled, "Preclinical Safety Pharmacology and Toxicology of FSD201, A Palmitoylethanolamide Composition,” provided support for the clinical development of FSD201, revealing well-tolerated doses of FSD201 in two different animal species, the company said.
FSD Pharma is a Toronto-based biotechnology company with three drug candidates in different stages of development.
Contact Sean at sean@proactiveinvestors.com