Welcome
"I am delighted and proud to present Aelis Farma to the financial community, a company founded on the discovery of a new natural defense mechanism of the brain. This mechanism protects the brain from the effects of a pathological hyperactivity of the CB1 receptor of the endocannabinoid system. The CB1 receptor, one of the main receptors in the brain, is involved in several diseases that are without treatment today. This major discovery, made with my team at Inserm (the French national institute of health), has enabled us to develop a new class of drugs, the CB1-SSi, which seems able to treat behavioral pathologies without causing side effects on normal behavior. This is a real first for treatments of brain diseases. Thanks to the experience of our team, we have succeeded in bringing two CB1-SSi to the clinical stage in a mere 8 years, thereby benefitting from long periods of exclusivity.
The first CB1-SSi, AEF0117, is designed to treat cannabis addiction and other disorders related to excessive cannabis use. The results generated to date have enabled us to conclude a major partnership with an international leader in the field of addiction, the Indivior group, which will accelerate the development and market access of AEF0117.
Our second drug candidate, AEF0217, should enable, for the first time, the treatment of several cognitive deficits including those associated with Down syndrome (Trisomy 21).
These two development programs, which target areas of high unmet therapeutic needs, have generated strong interest from the international medical and academic communities. We believe that we can successfully address these unmet medical needs, and thanks to the new compounds generated by our innovative platform, many others, thereby delivering a true paradigm shift in the treatment of brain diseases.”
Dr. Pier Vincenzo Piazza,
co-founder and CEO of Aelis Farma
Who are we?
Aelis Farma Management Team
Founder Leadership Trio: from Academia to Clinical POC in less than 7 years
Pier Vincenzo PIAZZA
CEO
MD, PhD
Scientist and Entrepreneur
- Formerly Head of Neurocentre Magendie at INSERM
- Grand Prix INSERM and Grand Prix of Neurology French Academy of Science for CB1-SSi
Valérie SCAPPATICCI
CFO
MBA
20 Years in Finance, Audit and Control Functions
- Formerly Associate Director at EY
- Accounting tailored to R&D needs
Stéphanie Monlezun
COO
PhD
15 Years in Pharmaceutical R&D
- From R&D project leader to COO in 6 years
- A 360° vision of drug development
Our mission
Aelis Farma is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative drug candidates targeting major disorders of the Central Nervous System (CNS) for which there is no current therapeutic solution.
A very innovative approach
To treat brain diseases thanks to a new class of drugs: Signaling Specific inhibitors of the CB1 receptorThe drug candidates developed by Aelis Farma belong to a new proprietary pharmacological class: the Signaling Specific inhibitors of the CB1 receptor (CB1-SSi), which seems to enable the treatment of brain diseases without inducing side effects on normal behavior.
The CB1 receptor is one of the most expressed neurotransmitter receptors in the brain1. It plays a very important role in the regulation of physiology and behavior2 and its pathological hyperactivity is involved in several diseases of the brain (cognitive deficits, addiction, psychosis, autism, Attention Deficit Hyperactivity Disorder - ADHD3).
To date, only one pharmacological class, antagonists, has been tentatively used to treat CB1 hyperactivity. However, antagonists tend to completely block the activity of the CB1 and consequently induce significant side effects, which make their clinical use difficult, if not impossible, thereby leaving many patients without treatment4.
The drug candidates developed by Aelis Farma are not antagonists but belong to a new proprietary pharmacological class: the Signaling Specific inhibitors of the CB1 receptor (CB1-SSi).
These molecules, which are the result of decades of academic research conducted by the Company’s co-founder and CEO, Dr. Pier Vincenzo Piazza, previously Director of the Inserm Magendie Neurocentre in Bordeaux, mimic a natural mechanism that the brain uses to fight hyperactivity of the CB1 receptor. This major discovery was published in Science5, one of the most prestigious scientific journals. The clinical trials performed to date by Aelis Farma have been able to show that CB1-SSi, thanks to their innovative mechanism of action never tested in humans before, are not only effective, but also well tolerated, and could provide therapeutic solutions to many diseases that are currently without treatment.
1 Busquets-Garcia et al., 2018a
2 Piazza et al., 2017
3 National Academies of Sciences, Engineering, and Medicine, 2017
4 Christensen et al. Efficacy and safety of the weight-loss drug rimonabant: a meta-analysis of randomised trials, Lancet. 2007.
5 “Pregnenolone can protect the brain from cannabis intoxication.” (Science, le 3 janvier 2014).
ADVERSE EFFECTS
PATHOLOGICAL STATE
GOOD TOLERABILITY
- Two first-in-class drug candidates at clinical stage for indications with high unmet medical needs
- AEF0117 to treat the harmful effects of excessive cannabis use
AEF0117 successfully completed a phase 2a study confirming its potential for the treatment of cannabis use disorders (addiction and psychosis), pathologies that are increasing rapidly in the context of the wave of legalization in Western countries
A phase 2b clinical trial, including approximately 330 patients and for which the protocol has been discussed with the FDA, will start in the second quarter of 2022 in the United States. This study will evaluate the efficacy of AEF0117 in the treatment of cannabis addiction. The coordinator and principal investigator of the study will be Prof. Frances Levin of Columbia University.
- AEF0217 to treat cognitive deficits in Down syndrome (Trisomy 21)
AEF0217 could become the first treatment for cognitive deficits caused by a hyperactivity of the CB1 receptor, such as those associated with Down syndrome (Trisomy 21), a genetic condition concerning an estimated 0.8 million people in the major Western countries6 and Japan. To date, there is no medical treatment for the cognitive deficits associated with Down syndrome, which constitutes a significant unmet medical need and a significant burden on the persons, their families, and healthcare systems.
AEF0217 is currently being evaluated in phase 1 clinical studies in healthy volunteers, with no major adverse effects reported to date in the first three patient cohorts. The drug is expected to enter clinical studies in Down syndrome subjects, which could provide the first proof of efficacy, in the fourth quarter of 2022.
1 The European Union, the United States, Canada and Australia.
- Aelis Farma's diversified portfolio of drug candidates
Given the involvement of the CB1 receptor in numerous pathologies and the strength of its diverse and exclusive library of CB1-SSi, Aelis Farma is also developing a portfolio of new CB1-SSi with differentiated pharmacological properties.
The immediate priority of these programs is orphan indications, such as 22q11 deletion syndrome or certain autism spectrum disorders (ASD), but also non-orphan indications such as attention deficit hyperactivity disorder (ADHD). Aelis Farma intends to initiate the development of a new drug candidate in one of these indications by the end of 2023.
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Contacts
Aelis Farma
Neurocentre Magendie
146, rue Léo Saignat
33 077 Bordeaux, France
NewCap
Investor Relations
Dusan Oresansky / Emmanuel Huynh
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