- Algernon sought direction from the FDA regarding the design and scope of the company’s preclinical and early phase stroke clinical programs
- The FDA is in agreement with the company’s planned preclinical efficacy experiments and offered guidance with regards to supportive preclinical safety studies
- Algernon is planning to be the first company in the world to test DMT in human clinical trials for stroke
- Algernon is a clinical-stage pharmaceutical development company
- Algernon Pharmaceuticals Inc. (AGN) is up 6.45 per cent, trading at C$0.165 per share at 10:25 am ET
Algernon Pharmaceuticals (AGN) has received positive feedback from the FDA regarding its DMT stroke clinical research program.
AP-188 (“N,N-Dimethyltryptamine” or “DMT”), a known psychedelic compound that is part of the tryptamine family, as an adjunct to physical therapy in the rehabilitation of stroke.
In a Pre-IND request submitted earlier this year, Algernon sought direction from the FDA regarding the design and scope of the company’s preclinical and early phase stroke clinical programs. The FDA is in agreement with the company’s planned preclinical efficacy experiments and offered guidance with regards to supportive preclinical safety studies. In addition, the FDA provided valuable input into the design of the company’s planned Phase 1 clinical trial, which will be conducted through Hammersmith Medicines Research in the UK, in Q4 2021.
“On February 1, 2021, Algernon announced that it was planning to be the first company in the world to test DMT in human clinical trials for stroke, and that is an objective we are aggressively pursuing,” said Christopher J. Moreau CEO of Algernon Pharmaceuticals.
“While we will begin with investigating DMT as an adjunct to physical therapy in the rehabilitation of stroke patients, we are currently engaged in preclinical research that will inform us on our planned Phase 2 for ischemic stroke as well.
Algernon will file an additional Pre-IND meeting request with the FDA for its planned ischemic stroke program when its preclinical research program is complete.”
Algernon has filed new provisional patents for new forms of DMT, in addition to formulation, dosage and method of use claims for ischemic stroke. The company has also filed claims for combination therapy of DMT and Constraint-Induced Movement Therapy.
Algernon is a clinical-stage pharmaceutical development company that investigates safe, approved drugs for new disease applications.
Algernon Pharmaceuticals Inc. (AGN) is up 6.45 per cent, trading at C$0.165 per share at 10:25 am ET.
