Algernon Pharmaceuticals Inc. (CSE:AGN, OTCQB:AGNPF) has provided an update on its planned phase 1 clinical human study of AP-188 (dimethyltryptamine or DMT), a hallucinogenic tryptamine drug, for use in stroke treatment.
The company said it is currently working to complete the intravenous formulation (IVF) that will be used in the phase 1 DMT study and announced that it has retained the Centre for Human Drug Research (CHDR) and its affiliated pharmacy at the Leiden University Medical Center in the Netherlands to complete the work.
The plan is for the study to begin in September, Algernon said.
READ: Algernon Pharmaceuticals includes novel salt forms of DMT as part of its intellectual property patent applications
The company had previously announced that it had filed for a Clinical Trials of Investigational Medicinal Products (CTIMP) application with the UK Medicines and Healthcare Products Regulatory Agency (UK MHRA) via the combined review service, which provides for a single application route for both clinical trial authorization and ethics approval.
The original plan was to complete the IVF in the onsite pharmacy at Hammersmith Medicines Research (HMR) in London, prior to the phase 1 DMT study beginning. However, to meet the specifications requested by the UK MHRA, it was determined that a new vendor would be needed that had additional technical cGMP-suite capabilities.
After working to identify qualified vendors that could perform the needed work in the required time period, Algernon selected CHDR. In addition to its fill finish cGMP-suite services, CHDR is also a world class clinical trial center, performing approximately 60 early-phase clinical studies per year, the company noted.
The primary focus of the planned Phase 1 DMT study is to investigate prolonged intravenous infusion of DMT, for durations which have never been clinically studied.
The first part of the study will use a single-escalating dose design while the second part will test the effects of repeated administrations of the highest safe dose. There will be up to 60 healthy volunteers enrolled across the two parts of the study, which will include both psychedelic experienced and psychedelic naive patients.
Algernon said the resulting data generated will help it plan both its phase 2 acute stroke and rehabilitation studies more effectively.
DMT is a hallucinogenic tryptamine drug producing effects similar to those of other psychedelics like LSD, ketamine, psilocybin and psilocin. Algernon has filed provisional patents for new salt forms of DMT, in addition to formulation, dosage and method of use claims for ischemic stroke.
It has also filed claims for combination therapy of DMT and stroke rehabilitation including Constraint Induced Movement Therapy.
Algernon is a drug re-purposing company that investigates safe, already approved drugs, including naturally occurring compounds, for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets.
Contact the author at jon.hopkins@proactiveinvestors.com