Algernon Pharmaceuticals is working to complete an intravenous formulation (IVF) that will be used in its Phase 1 DMT study investigating the compound’s efficacy as a treatment for stroke patients.
The study is aiming to identify the safety, tolerability and pharmacokinetics of DMT when administered as an intravenous bolus followed by prolonged infusion – durations that 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 naïve patients.
To develop the formulation for the study, Algernon Pharmaceuticals 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 company has confirmed that it had filed for a Clinical Trials of Investigational Medicinal Products application with the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), stating that the key feedback provided by the MHRA focussed on the IVF of DMT for administration.
Algernon Pharmaceuticals has said that 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, it has selected CHDR and the IVF work is in progress.
Data generated from the study will help the Algernon Pharmaceuticals to plan both its Phase 2 acute stroke and rehabilitation studies more effectively.
Algernon has filed provisional patents for new salt forms of DMT, in addition to formulation, dosage and method of use claims for ischemic stroke, and has also filed claims for combination therapy of DMT and stroke rehabilitation including Constraint Induced Movement Therapy.
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