Aelis Farma announces the positive results of safety studies in healthy volunteers and the authorization to initiate the first study in people with Down syndrome with its drug candidate AEF0217 aimed at the treatment of cognitive disorders
• AEF0217 is being developed to be the first treatment for cognitive deficits caused by hyperactivity of the CB1 receptor, and as a first indication those associated with Down syndrome (trisomy 21) which constitute a major unmet medical need to date.
• The single and multiple dose escalation study of AEF0217 demonstrated the safety, tolerance and good bioavailability of AEF0217 in healthy volunteers.
• Based on these favorable results, the AEMPS (Spanish Agency for Medicines and Medical Devices) has authorized a phase 1/2 study in adults with trisomy 21. This study will assess the safety, tolerance and plasma exposure while providing potential preliminary indications of AEF0217 activity.
• The first inclusions in the phase 1/2 study are expected by the end of the year.
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