- Algernon Pharmaceuticals (AGN) subsidiary Algernon NeuroScience has dosed the first subject in its Phase 1 clinical study of an intravenous formulation of AP-188
- The trial is taking place at the Centre for Human Drug Research in Leiden
- The first part of the study will use a single-escalating dose design aimed at identifying a safe and tolerable dose that will not produce psychedelic effects
- The second part will test the effects of repeated administrations of this same dose
- In the end, there will be up to 60 healthy volunteers enrolled across the two parts of the study
- Algernon Pharmaceuticals is up 0.44 per cent, trading at C$2.29 at 11:20 pm EST
Algernon Pharmaceuticals (AGN) subsidiary Algernon NeuroScience dosed the first subject in its Phase 1 clinical study of DMT’s intravenous formulation of AP-188.
The purpose of the Phase 1 study is to identify the safety, tolerability, and pharmacokinetics of DMT when administered as an intravenous bolus followed by a prolonged infusion for durations which have never been studied clinically.
In addition to Algernon filling for patents for DMT pamoate and nicotinate, the company also filed claims for a combination therapy of DMT and stroke rehabilitation, including Constraint Induced Movement Therapy.
Taking place in the Netherlands, the trial is taking place at the Centre for Human Drug Research in Leiden.
“I am delighted that Algernon NeuroScience has begun their Phase 1 DMT study,” said Dr. Rick Strassman, author of DMT: The Spirit Molecule and Algernon consultant.
“I believe a prolonged infusion of a sub-psychedelic dose of this compound will be safe and may activate multiple neurodegenerative pathways, including elevations of BDNF,” continued Dr. Strassman.”
He added, “Such effects may prove beneficial in ischemic stroke patients acutely and in their rehabilitation.”
Algernon consultant Dr. David Nutt stated, “It appears from the pre-clinical data that DMT is promoting neuroplasticity, a key mechanism in recovery once the stroke has occurred, which is a new and exciting approach to stroke treatment.”
Professionals from the company seem to be excited about the findings and remain hopeful for future studies and results.
In addition, several pharmacodynamic measures believed to be associated with neuroplasticity, including both measurements of biochemical markers and electroencephalographic readings, will be recorded.
The first part of the study will use a single-escalating dose design aimed at identifying a safe and tolerable dose that will not produce psychedelic effects.
In contrast, the second part will test the effects of repeated administrations of this same dose.
Up to 60 healthy volunteers enrolled across the two parts of the study, which will include both psychedelic-experienced and psychedelic naïve patients.
Since there have already been several Phase 1 studies successfully conducted on DMT, the company is optimistic about safety risks and future findings.
According to the company, generated data will help plan a Phase 2 acute stroke and rehabilitation study more effectively.
Algernon NeuroScience is a private equity subsidiary of Algernon Pharmaceuticals and has been created to advance the Company’s DMT stroke research program.
Algernon Pharmaceuticals is a Canadian clinical-stage drug development and repurposing company investigating multiple drugs for unmet global medical needs.
Algernon Pharmaceuticals is up 0.44 per cent, trading at C$2.29 at 11:20 pm EST.
