Algernon Pharmaceuticals Inc said it has filed a scientific advice meeting request with the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for a Phase 1/2a stroke study with its DMT-based drug candidate, AP-188.
The company said the MHRA encourages companies to seek scientific advice before beginning clinical trials in the UK. These meetings are similar to the Pre-Investigational New Drug Application (Pre-IND) meetings offered by the US Food and Drug Administration.
DMT, or N,N-dimethyltryptamine, is a known psychedelic compound that is part of the tryptamine family.
READ: Algernon Pharmaceuticals "very excited" by preclinical data on DMT candidate
Through the MHRA process, the company said it will confirm that its chemistry, manufacturing and controls information, pre-clinical data, and Phase 1/2a clinical plans are appropriate for submission of a Clinical Trial Authorisation (CTA) application for a study with DMT in the UK, which is planned for the fourth quarter of this year.
It said the Phase 1 portion will investigate the safety, dose, and pharmacokinetics of DMT, while the Phase 2a part will additionally examine the use of DMT as an adjunctive treatment to Constraint-Induced Movement Therapy for the treatment of upper-limb dysfunction in stroke patients.
During the Phase 1 study of DMT, it will also be able to evaluate if a sub hallucinogenic dose of DMT could be used for the treatment of hemorrhagic stroke patients in addition to patients who have suffered an ischemic stroke. This would be a significant discovery and could lead to a clinical trial to evaluate if patients would benefit from DMT shortly after their stroke has occurred, it added.
The company recently confirmed, in its own in vitro preclinical study, that DMT increased the growth of cortical neurons by 40% with statistical significance in one arm of the study, when compared to control. Algernon also reported that the increased growth was achieved with a sub hallucinogenic dose.
“We are pleased to initiate formal discussions of our clinical plans for DMT with the MHRA,” Algernon Pharmaceuticals CEO Christopher Moreau said in a statement.
“The MHRA’s familiarity with DMT means the agency is well-positioned to advise the company on its clinical research program,” he added.
Algernon is a drug re-purposing company that investigates safe, already approved drugs for new disease applications, moving them into new human trials, developing new formulations and seeking new regulatory approvals in global markets.
Contact the author at stephen.gunnion@proactiveinvestors.com