The proposed design is a randomized and double-blind trial of 200 dogs that will compare FSD201 dosed twice daily to a placebo for the treatment of canine inflammatory bowel disease
FSD Pharma Inc (NASDAQ:HUGE) (CSE:HUGE) said it has submitted to the US Food and Drug Administration an Investigational New Animal Drug Application (IND) for the use of FSD201 to treat gastrointestinal enteropathy in dogs.
The application has been accepted for review, the company added in a statement.
The proposed trial design is a randomized, double-blind, placebo-controlled, crossover, study comparing FSD201 (ultra micronized palmitoylethanolamide, or ultramicronized PEA) dosed twice daily for 30 days to a placebo for the treatment of canine inflammatory bowel disease.
READ: FSD Pharma in license agreement with Innovet Italia to develop FDA-approved drugs to treat gastrointestinal diseases in dogs and cats
FSD Pharma said the primary endpoint will be a validated diarrhea score, evaluated by both the treating veterinarian and the dog owner. The trial will be conducted at five-10 sites in the US, and will enroll up to 200 dogs.
In other company news, FSD Pharma thanked shareholders for the strong support it has received ahead of its upcoming Annual and Special Meeting of Shareholders.
On May 5, FSD Pharma announced that Institutional Shareholder Services Inc (ISS), a leading independent international corporate governance analysis and proxy advisory firm, had recommended that shareholders vote for all management director nominees and for the elimination of the dual-class share structure at the meeting.
Shareholders are urged to vote immediately to ensure their proxies are received by the proxy voting deadline – no later than 9 am (Toronto time) on May 12. Shareholders with questions or who require assistance voting their shares should contact the company's proxy solicitation agent Gryphon Advisors Inc at 1.833.292.5847 toll-free in North America (1.416.902.5565 by collect call) or by email at inquiries@gryphonadvisors.ca.
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