| 2026-07-16 |
Aelis Farma |
Results Aelis Farma receives a positive recommendation from the Independent Data Monitoring Committee to continue the Phase 2b study of AEF0217 in people with Down syndrome without modification aelisfarma.com ↗
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| 2026-01-12 |
Aelis Farma |
Regulatory Aelis Farma receives a positive opinion from EMA Pediatric Committee on the Pediatric Investigation Plan for AEF0217 in Down syndrome aelisfarma.com ↗
The EMA’s Pediatric Committee (PDCO) has delivered a favorable consensus opinion on the Pediatric Investigational Plan (PIP) of Aelis Farma’s first-in-class drug candidate AEF0217 for the treatment of adaptive behavior and cognitive impairments associated with Down syndrome. |
| 2025-12-02 |
Aelis Farma |
Regulatory Aelis Farma obtains regulatory approval of the Phase 2B trial with AEF0217 in people with Down syndrome aelisfarma.com ↗
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| 2023-06-12 |
Aelis Farma |
Results Preclinical data demonstrating the efficacy of AEF0217 in a genetic mouse model of autism spectrum disorder has been presented at the 2nd European Conference on Phelan-McDermid Syndrome aelisfarma.com ↗
The results showed the ability of AEF0217 to statistically significantly reverse behavioral, cognitive and motor deficits observed in a genetic mouse model of Phelan-McDermidSyndrome. |
| 2022-11-15 |
Aelis Farma |
Results Aelis Farma announces positive results from its safety trials in healthy volunteers and the authorization to start the first trial in people with Down syndrome with AEF0217, its drug candidate for the treatment of cognitive disorders aelisfarma.com ↗
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| 2021-11-29 |
Aelis Farma |
Results Aelis Farma announces good results from its first administration in humans for AEF0217, its first drug candidate for the treatment of cognitive disorders in Down syndrome aelisfarma.com ↗
The administration of AEF0217, using a dose in the expected therapeutic range, has good tolerability and demonstrates encouraging safety and plasma exposure characteristics for further clinical development. |