AELIS FARMA raises €11 million to accelerate the clinical development of a paradigm-shifting new class of drugs for treating cannabis addiction and cognitive disorders

• CB1-SSi, the new class of drugs developed by AELIS FARMA, targets the cannabinoid system with a breakthrough approach discovered by the Company’s founder and CEO (Science 2014 ^[1]).
• The most advanced CB1-SSi, AEF0117, currently in a Phase II study at Columbia University (NY, USA), is being developed for the treatment of cannabis addiction and cannabis-induced psychosis.
• The second CB1-SSi, AEF0217, will enter clinical trials in 2020 for the treatment of cognitive deficits in Down syndrome (Trisomy 21).

Bordeaux, December 13, 2019 – AELIS FARMA, a biotechnology company specialized in the treatment of brain disorders, announces today the completion of a €11 million financing round from the Region Nouvelle Aquitaine, Inserm Transfert Initiative, Bpifrance and the ACI, NACO and Aelis Innovation (a fund of IRDI Soridec Gestion) regional funds. This financing round, combined with €9 million in research grants from various organizations, including the National Institute on Drug Abuse of the NIH, will allow AELIS FARMA to complete by 2020, its first Phase II clinical trials for the treatment of cannabis-related disorders.

“AELIS FARMA’s is built around a breakthrough in neuropharmacology that can finally provide treatments for serious conditions with no available therapies today. This financing round provides the necessary resources to pursue the development of our two first-in-class drugs. AEF0117 is currently in Phase II at Columbia University in NY for the treatment of cannabis addiction and cannabis induced-psychosis, two health issues rapidly growing because of cannabis legalization in many countries. Our second drug, AEF0217, which will enter clinical trials in 2020, aims to treat cognitive deficits, and notably those associated with Down syndrome. We are anticipating US marketing approval for the most-advanced drug, AEF0117, by 2025”, says Dr. Pier Vincenzo Piazza, co-founder and CEO of AELIS FARMA.

Signaling Specific inhibitors of the CB1: a new pharmacological class for treating brain diseases

AELIS FARMA was founded in 2014 to develop the Signaling Specific inhibitors of the CB1 receptor (CB1-SSi), a new class of drugs discovered by the research group of Dr. Pier Vincenzo Piazza during his tenure as Director of the Neurocentre Magendie in Bordeaux, one of the major Neuroscience institute of Inserm (the French NIH).

CB1-SSi target the main receptor of the cannabinoid system, the CB1, which is implicated in numerous disorders of the nervous system (addiction, psychosis, cognitive deficits) and of peripheral organs (fibrosis, myopathies, diabetes). CB1-SSi, which have never been tested in humans before, allow to selectively block the cellular pathway overactivated during a disease state but do not modify normal physiological activities. Because of this unique mechanism of action CB1-SSi are efficacious in preclinical models of addiction, psychosis and cognitive deficits and have demonstrated an excellent safety profile in toxicology studies in animals and Phase I studies in humans. This is a notable difference from the inhibitors available today, antagonists, which, blocking all cellular activities of the CB1, induce significant side effects that have led to the discontinuation of their development.

€11 million raised to accelerate clinical development in cannabis addiction

This financing round, bring to €12.5 million the total capital raised by AELIS FARMA from previous and new investors – the Region Nouvelle Aquitaine, Inserm Transfert Initiative, Bpifrance, the ACI and NACO regional funds and Aelis Innovation, a fund of IRDI Soridec Gestion.

Strong of these resources, combined with €9 million provided by various non-dilutive financing, the company is performing two clinical studies in cannabis-related disorders. The first, a Phase II trial in collaboration with Columbia University (NY, USA), is analyzing AEF0117’s effects on 64 patients with cannabis addiction. The second will assess the effects of AEF0117 on the psychotic symptomatology induced by cannabis. Results from these studies are expected by the end of 2020.

The market of cannabis-related disorders is rapidly growing with an estimated 12 million individuals worldwide and 4.5 million in the US diagnosed with Cannabis Use Disorders (CUD), the definition of cannabis addiction in the main diagnostic manual for psychiatric diseases the DSM5.

A strong and diverse pipeline targeting emerging therapeutic area
AELIS FARMA develop a second drug candidate, AEF0217, that will enter Phase I clinical trials in 2020. AEF0217 aims to improve cognitive abilities in subjects with Down syndrome. Cognitive deficits in Down syndrome, for which there is currently no treatment, have major social and economic consequences for the patients, their families and society. AEF0217 has been able to reverse cognitive impairments in the most stringent preclinical model of Down’s syndrome and has also shown efficacy in animal models of ageing-related cognitive impairments.

AELIS FARMA pipeline is enriched by a screening platform that provides a continuous flow of new drug candidates. Given the involvement of the CB1 in multiple disorders, these new CB1-SSi offer the possibility of developing potential treatments for certain myopathies, fibrotic and metabolic diseases.

[1] “Pregnenolone can protect the brain from cannabis intoxication.” (Science, January 3, 2014)

About Aelis Farma:

AELIS FARMA is a clinical-stage biotechnology company founded in 2014 as a spin-off of the Neurocentre Magendie in Bordeaux, one of the major Neuroscience institute of INSERM (the French National Institute of Health and Medical Research). AELIS FARMA’s mission is to develop a new pharmacological class, the Signaling Specific inhibitors of the CB1 receptor (CB1-SSI) that have been discovered by the research team of Dr. Pier Vincenzo Piazza, the Company’s CEO, during his tenure as director of the Magendie Institute. For this discovery Dr. Piazza has been awarded the Grand Prix of INSERM and the Grand Prix of Neurology of the French Academy of Science, that are among the most prestigious French scientific award.

CB1-SSi have potential application for the treatment of numerous disorders. The Company is currently developing two first-in-class drug candidates: AEF0117, and AEF0217.

AEF0117, which targets cannabis related disorders (addictions and psychosis), is currently being studied in a Phase II trial in cannabis addicts performed at Columbia University (NY, USA). The effects of AEF0117 on cannabis-induced psychotic symptomatology will also be evaluated in an exploratory study in 2020.

AEF0217, which is being developed for the treatment of cognitive impairments, will enter Phase I clinical trials in 2020 and will be tested as a therapy of cognitive deficits in Down syndrome.

AELIS FARMA has 12 staff members, headquarters at the Neurocentre Magendie in Bordeaux and has received financial support from the Nouvelle-Aquitaine region, Inserm Transfert Initiative, Bpifrance, ACI, NACO and Aelis Innovation regional funds.