Algernon Pharmaceuticals Inc revealed that it has had a positive meeting with UK regulator, the MHRA, and aims to file a clinical trial authorisation (CTA) application for a Phase 1/2a study of DMT to treat stroke as soon as possible.
The drug-repurposing company is advancing AP-188 (N,N-Dimethyltryptamine, or DMT), a psychedelic compound, as a potential treatment for stroke and had a scientific advice meeting with the United Kingdom Medicines and Healthcare Products Regulatory Agency (UK MHRA).
The Phase 1 part of the study at Hammersmith Medicines Research in London, UK is earmarked to begin in January next year, added Algernon.
"In addition, and based on the feedback received, the company is also considering focusing on DMT as a possible treatment for acute stroke for the Phase 2a part of the study, in addition to investigating DMT as an adjunctive treatment for stroke rehabilitation therapy," the company said.
READ: Algernon Pharmaceuticals reports positive pre-clinical data on DMT candidate to treat stroke
Christopher J. Moreau, CEO of Algernon Pharmaceuticals, summed up: "We were very encouraged by today’s meeting with the UK MHRA.
"The feedback we received was very helpful and we look forward to working with the agency as we move forward with the important work of investigating DMT as a possible therapy for stroke patients globally."
Algernon submitted a pre-investigational new drug (IND) request to the US regulator - the Food and Drug Administration (FDA) - in March this year.
And, in June 2021, it revealed that all of the required permits and licenses for the drug's manufacture had been received.
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