clinical trial authorisation (CTA) application for a Phase 1/2a study using DMT for stroke treatment as soon as possible. The pharmaceutical business is developing AP-188 (N,N-Dimethyltryptamine, or DMT), which is a psychedelic substance, as a possible stroke therapy and recently met with the United Kingdom Medicines and Healthcare Products Regulatory Agency (UK MHRA) for scientific guidance.
According to Algernon, the Phase 1 segment of the trial, which will be conducted at Hammersmith Medicines Research in London, UK, is scheduled to start in January 2022. The company discussed its future research areas and possible treatment options for stroke. It said, “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”.
Christopher J. Moreau, CEO of Algernon Pharmaceuticals, expressed delight over the positive results from UK MHRA. He said, “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.”
Earlier in March, Algernon filed a pre-investigational new drug (IND) request to the US regulator, the Food and Drug Administration (FDA). Accordingly, it stated in June 2021 that the firm has obtained all the necessary permissions and licenses for the production of the drug.
