Pre-IND U.S. FDA & CTA- Health Canada
Based on historical data showing that several DMT Phase 1 studies have already been conducted, the Company believes that it will be able to use this data to seek approval to begin its own Phase 1 study without having to complete certain toxicology work.
In order to confirm its regulatory plans, Algernon’s goal is preparing to submit a pre-IND (Investigational New Drug) meeting request with the U.S. FDA in calendar Q1 of 2021, and to present all elements of the Company’s clinical program design in order to receive their guidance and advice.
The Company also intends to submit a Clinical Trial Application (CTA) to Health Canada in order to obtain additional insight and options for the Company’s planned clinical research program.
U.S. FDA Breakthrough Therapy Designation
Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).
The Company plans to file an application with the U.S. FDA for a Breakthrough Therapy designation as soon as possible.