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R&D Portfolio and Pipeline
Drug candidates
Indications
Discovery
Preclinical Development
Clinical Phase 1
Clinical Phase 2
Clinical Phase 3
Patent
AEF0117
for cannabis-related
disorders
disorders
AEF0217
for cognitive
disorders
disorders
New<br>CB<sub>1</sub>-SSi
for other cannabinoid-
dependent diseases
dependent diseases
AEF0117
for cannabis-related disorders
Stage:
Clinical phase 2
AEF0117
for cannabis-related disorders
Stage:
Clinical phase 2
AEF0117
for cannabis-related disorders
AEF0217
for cognitive disorders
Stage:
Clinical phase ½
AEF0217
for cognitive disorders
Stage:
Clinical phase ½
AEF0217
for cognitive disorders
Stage:
Discovery
New
CB1-SSi
CB1-SSi
for other cannabinoid-dependent diseases
Stage:
Discovery
New
CB1-SSi
CB1-SSi
for other cannabinoid-dependent diseases
Stage:
Discovery
New
CB1-SSi
CB1-SSi
for other cannabinoid-dependent diseases
AEF0117
for cannabis-related
disorders
disorders
AEF0117 has an open FDA IND and entered a phase 2b clinical trial in the United States in Q2 2022.
AEF0117 is a new molecular entity (NME) developed by Aelis Farma to treat the harmful effects of excessive cannabis use.
AEF0117's major characteristics:
•
High potency in inhibiting the effects of cannabis’ active ingredient, THC, in several animal species including primates without side effects on normal behavior.
•
Favorable ADMET profile, with good oral absorption, brain access, long half-life and no toxic or adverse effects identified to date (Therapeutic index >13,000)
•
Good pharmacokinetic, safety and efficacy profile in healthy volunteers and cannabis addicts.
The clinical development of AEF0117 is supported by grants from NIDA-NIH (National Institute on Drug Abuse of the National Institute of Health, US).
AEF0217
for cognitive
disorders
disorders
AEF0217 has successfully completed the Phase 1 clinical program and will enter Phase 1/2 study in subjects with Down syndrome before end of 2022 in Europe.
AEF0217 is the second drug candidate developed by Aelis Farma. It is specifically designed for the treatment of cognitive deficits.
AEF0217's major characteristics:
•
High potency in reversing cognitive deficits in validated translational models of Down syndrome, Fragile X syndrome and aging related cognitive impairments without identifiable behavioral side effects even in fragile trisomic and aged mice.
•
Very favorable ADMET profile, with good oral absorption, brain access, long half-life and a good tolerability (therapeutic index = 640).
•
Good pharmacokinetic, safety and efficacy profile in healthy volunteers
Clinical development of AEF0217, for which its first therapeutic indication is the cognitive deficits in Down syndrome, is supported by a grant from the EU (Horizon Programme H2020; Improving Cognition in Down syndrome, Grant N° 899986).
New
CB1-SSi
CB1-SSi
for other cannabinoid-
dependent diseases
dependent diseases
Aelis Farma’s platform provides new Signaling Specific inhibitors of the CB1 receptor.
New CB1-SSi are New Molecular Entities (NME) with an original structure and improved pharmacodynamic properties, which will provide drug candidates for the treatment of other CB1-dependent diseases, including several orphan diseases.
