Mr. Moreau is a seasoned business professional in the life sciences sector with a strong background in biotechnology research, business development and a deep expertise in the capital markets. Mr. Moreau was previously President& CEO and Director of a publicly traded company focussed on the research& development of screening tests for prostate cancer, skin cholesterol and type 2 diabetes. He has raised in excess of $30 million from the capital markets and has over 30 years of senior management experience in private &publicly traded company environments.
How did you first become interested in psychedelics and see DMT as an opportunity for new, novel medical treatments?
In December of 2021, a large shareholder in Algernon approached me and asked if I was aware of the investor interest and activity in the psychedelic space because he thought Algernon should get involved in some way.
I met with my Science and research team and said “let’s have a look but we won’t proceed unless there is a pure pharma play available.” By a pharma play, I mean a clear indication, potential regulatory approval ( label for an indication) and a solid intellectual property position, all of which we now have with our DMT for stroke research program.
What is the mission of Algernon Pharmaceuticals?
To investigate and develop drugs for indications with unmet clinical needs for the treatment of global disease indications.
Why did you choose to pursue DMT as your lead candidate for stroke treatment?
When we started to look at the literature, DMT was shown to increase neuroplasticity in a number of preclinical research studies. In addition there was what I would call a seminal study of DMT in a rat stroke model which showed that DMT reduced infarct volume in the brain ( area of damage) and provided almost a full recovery of motor function with significance. That study charted the course for our DMT clinical stroke research program.
What clinical scientific validation have you seen that demonstrates that DMT has the potential to be a powerful tool for stroke treatment and rehabilitation?
Some of the Studies:
1. PsychedelicsIncreased Arbor Complexity After 72-hour Treatment In Vitro*
* Ly et al. CellReports (2018) 23:3170-82
2. Cortical Neurons When Treated With DMT for 24HR a 2X Increase in BDNF Protein was Observed.
* Ly et al. CellReports (2018) 23:3170-82
3. Application of BDNF to Cortical Neurons Showed a Dose-Dependent Response on Neuritogenesis.
* Ly et al. CellReports (2018) 23:3170-82
4. FollowingStroke in Rats, Rehabilitation Significantly Improved Skilled Reaching Ability,but Blocking BDNF Synthesis Reduced this Improvement
*Ploughman et al.Stroke (2009) 40:1490-1495
5. Ina Meta-Analysis Subjects (62 Studies) with Stroke (n=1856) Showed Lower BDNFLevels Compared with Healthy Controls (n=1191)
*Mojtabavi et al(2022)
6. DMTShows Preclinical Benefits at Sub-Psychedelic Doses – IN VIVO
*Ly et al. CellReports (2018) 23:3170-82
7. Effect of DMT on Motor Function RecoveryUtilizing the Serial ‘Staircase Testing’
*Nardai et al,Experimental Neurology 327 (2020) 1132452
8. InfarctVolume 24 Hrs. After Were SignificantlyLower in DMT Treat Animals Compared to Controls
*Nardai et al,Experimental Neurology 327 (2020) 113245
What role do Dr. Strassman and Professor Nutt play at Algernon and in your DMT research?
As consultants to Algernon, they play a vital role as scientific and medical sounding boards providing input and guidance for our research plans and programs. They also participate in media interviews answering questions about Algernon’s programs and share their personal views on the DMT science and the data. This also provides Algernon with a great deal of credibility globally because they are so highly respected.
What leading scientists have you brought onto the team with expertise on strokes?
Dr. Dennis Choi MD, PhD
Dr. Choi is Professor of Neurology at Stony Brook University, having previously chaired that department and served as Director of the Neurosciences Institute there. Other prior positions have included Director of the Brain ScienceInstitute at the Korea Institute of Science and Technology, Vice President forAcademic Health Affairs at Emory University, Executive Vice President forNeurosciences at Merck Research Labs, and Head of Neurology at WashingtonUniversity Medical School.
Dr. Anthony Rudd
Anthony Rudd, MB,BChir, FRCP, CBE is an emeritus professor of Stroke Medicine at Kings CollegeLondon and recently retired as a consultant stroke physician at Guy’s and StThomas’ Hospital. He was the London Stroke Clinical Director from 2010-2019 andthe National Clinical Director for Stroke for NHS England from 2013-2019, wherehe oversaw dramatic improvements in the paradigm of NHS stroke treatment.
Dr. Robert Simister
Robert Simister MA MBBS PhD FRCP is a consultant neurologist and stroke physician as well as anhonorary senior lecturer at University College London, where he also serves asthe Clinical Lead for the Comprehensive Stroke Service and the ClinicalDirector of Stroke Medicine and Acute Neurology. Since 2019, he has been theJoint Clinical Director for the London Stroke Clinical Network.
Dr. Wolf, PT, PhD,FAPTA,
Dr. Wolf is a professor in the Department of Rehabilitation Medicine, Emory University School of Medicine, where he explores novel interventions to improve extremity use inpatients with stroke as well as mechanisms of cortical reorganization and inter-joint coordination associated with such changes. He is a world expert in physical therapy, a prolific and innovative researcher and leader who has made seminal contributions to patient care, and a highly sought-after lecturer and teacher who has been a valued mentor to students, residents and faculty.
Whatis AP-188? Is it a novel compound developed by Algernon?
AP-188 is a novel salt form of (“N,N-dimethyltryptamine” or “DMT”), the Company included in its intellectual property filings.
What are the novel salt forms of DMT you’ve created and how will adding pamoate or nicotinate offer more neuroprotective benefits?
Algernon’s novel salt forms of DMT include nicotinate and pamoate which are commonly used counter ions when producing salts.
A novel salt form of a drug is a new and separate structure from the original compound and is considered a new composition of matter, anchoring the Company’s novel patent filings. Many drug compounds’ core structures can be paired with another compound to form a salt. Different salts can improve the core drug in sever always, including improved efficacy, safety/tolerability, and stability.
Nicotinic Acid(Vitamin B) Promotes Neuroplasticity and BDNF Expression and PamoicAcid Activates GPR35 and Protects Against Ischemia by RecruitingMonocyte-Derived Macrophages.
Can you talk more about your Phase I clinical trial on DMT using AP-188?
Phase 1 DMT Stroke Study Summary
The purpose of the study is to identify the safety, tolerability, and pharmacokinetics of DMT when administered as an intravenous bolus followed by prolonged infusion, for durations which have never been studied clinically. 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, while the second part will test the effects of repeated administrations of this 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.
What other organizations or teams are you working with to help advance your clinical trials?
Founded in 1986, the CHDR is an independent institute that specializes in cutting-edge early-phase clinical drug research. During the pandemic of 2021 the CHDR completed renovations to greatly increase their clinical capacity while also being responsible for 77 scientific publications.
CHDR’s custom-built facility is situated in the heart of theLeiden Bio Science Park within Leiden University (LUMC) campus adjacent to the medical school and GMP pharmacy. CHDR’s long-standing partnership with the LUMC facilitates direct access to an extensive knowledge base in Leiden, as well as access to different patient populations for trial recruitment. This partnership as well as the combined expertise of two board certified neurologists and post-doctorate clinical scientists with neuroscientific backgrounds will be valuable assets as Algernon’s DMT program moves forward. In addition, they have performed multiple clinical trials with psychedelic substances, including DMT, and have a suite of rooms specifically created for that purpose.
The Company had initially retained the CHDR and its affiliated pharmacy at the Leiden University Medical Center in the Netherlands, to develop the IVF that will be used in its Phase 1 DMT study. After working with the CHDR team, it was decided to move forward with an ethics and clinical trial application in Netherlands as well to move Algernon’s DMT stroke research program forward as quickly as possible.
Whydid you choose to focus on a sub-psychedelic dose of DMT? Are there risks forstroke patients taking a hallucinogen?
When you have had a stroke, you have suffered a brain injury and typically with that comes some mental confusion and severe anxiety. Sending a stoke patient into a hallucinogenic state would not be comfortable and could even be dangerous. There is no “spirit guide to help inform them of the upcoming experience and so it would be a very fear fill ride into the unknown. Many stroke treatments in the clinical phase have failed because they caused hallucinations with patients jumping out of hospital beds and getting injured.
How does DMT promote healing and growth in the brain?
DMT increases the production of brain derived neurotrophic factor (BDNF) a known neuronal growth factor that promotes neuroplasticity, an important process that helps the brain heal after an injury like a stroke.