Developer · AELIS · France

Aelis Farma S.A.

Clinical-stage biopharmaceutical company founded in Bordeaux, France in 2013, developing a novel class of CB1 receptor signaling-specific inhibitors (CB1-SSi) of the endocannabinoid system. Lead candidates are AEF0117 for cannabis use disorder and AEF0217 for cognitive disorders including those linked to Down syndrome.

aelisfarma.com ↗

2compounds
2programs
2indications
Phase 2lead asset

Phase distribution

  • Phase 22

Modality

  • Small molecule 2

Mechanism focus

Pipeline (2)

Deals & partnerships

  • Jun 8, 2021Option exerciseAelis Farma grants Indivior an exclusive option-license for AEF0117 in cannabis-related disordersStrategic collaboration and option-license agreement under which Aelis Farma granted Indivior an option to an exclusive worldwide license for AEF0117 (cannabis-related disorders, including addiction and psychosis). Indivior paid a $30M upfront; the deal provided for a $100M license fee on option exercise plus up to $340M in development/regulatory/commercial milestones and 12-20% royalties. After the Phase 2b CUD study missed its endpoints (reported Sept 2024), Indivior indicated it did not intend to exercise the option pending further analysis, leaving the license unexercised.AEF0117 (lixosicone)source ↗

Catalysts · 1 upcoming · 3 reported

Recently reported

  • 2025-03-26missed

    AEF0117 (lixosicone)forCannabis use disorderFull results

    Final SICA2 analysis: primary endpoint confirmed not met; 1 mg reduced days of cannabis use (-16% vs placebo, P=0.077) with a positive high-motivation subgroup (P=0.038).

    source ↗

  • 2024-11-18met

    AEF0217forDown SyndromeTopline data

    Positive Phase 1/2 in young adults with Down syndrome: safety primary met; AEF0217 0.2 mg improved several VABS adaptive-behavior domains and modified a CB1-dependent EEG target-engagement marker vs placebo.

    source ↗

  • 2024-09-03missed

    AEF0117 (lixosicone)forCannabis use disorderTopline data

    Phase 2b SICA2 missed its primary responder endpoint (cannabis use <=1 day/week) and key secondary abstinence endpoints.

    source ↗

Recent activity

  • Jan 12, 2026Phase changeAEF0217·Down SyndromePhase 2EMA Pediatric Committee (PDCO) delivered a positive opinion on the Pediatric Investigation Plan (PIP) for AEF0217 in Down syndrome, agreeing a stepwise pediatric program (birth to <18 years) and accepting the current formulation and preclinical/PK package.source ↗
  • Dec 22, 2025Phase changeAEF0217·Down SyndromePhase 2International Phase 2b dose-finding trial (NCT07334912; AEF0217-201) started; first patient first visit performed in December 2025 after initial regulatory approval, with recruitment underway across France, Italy and Spain (announced 2026-03-21).source ↗
  • Mar 26, 2025ReadoutAEF0117 (lixosicone)·Cannabis use disordermissedFinal SICA2 analysis: primary endpoint confirmed not met; 1 mg reduced days of cannabis use (-16% vs placebo, P=0.077) with a positive high-motivation subgroup (P=0.038).source ↗
  • Nov 18, 2024ReadoutAEF0217·Down SyndromemetPositive Phase 1/2 in young adults with Down syndrome: safety primary met; AEF0217 0.2 mg improved several VABS adaptive-behavior domains and modified a CB1-dependent EEG target-engagement marker vs placebo.source ↗
  • Oct 7, 2024Phase changeAEF0217·Down SyndromePhase 1/2Phase 1/2 trial (NCT05748405) completed (primary completion and completion date 2024-10-07). On 2024-11-18 Aelis announced positive results: the safety primary endpoint was met and AEF0217 0.2 mg improved several VABS adaptive-behavior domains and a CB1-dependent EEG target-engagement parameter vs placebo.source ↗
  • Sep 4, 2024Phase changeAEF0117 (lixosicone)·Cannabis use disorderPhase 2Indivior announced it does not expect to exercise its 2021 option to license AEF0117 following the Phase 2b primary-endpoint miss; rights remain with Aelis Farma.source ↗
  • Sep 3, 2024ReadoutAEF0117 (lixosicone)·Cannabis use disordermissedPhase 2b SICA2 missed its primary responder endpoint (cannabis use <=1 day/week) and key secondary abstinence endpoints.source ↗
  • Jun 22, 2023Phase changeAEF0117 (lixosicone)·Cannabis use disorderPhase 1Phase 1 SAD (NCT03325595) and MAD (NCT03443895) and Phase 2a human laboratory study (NCT03717272) reported together in Nature Medicine: AEF0117 was safe/well tolerated and reduced cannabis' positive subjective effects (19% at 0.06 mg, 38% at 1 mg vs placebo, P<0.04) and self-administration (1 mg, P<0.05), without precipitating withdrawal.source ↗
  • Dec 15, 2022Phase changeAEF0217·Down SyndromePhase 1/2First patient recruited into the Phase 1/2 trial (NCT05748405; AEF0217-102), a randomized, double-blind, placebo-controlled 4-week study in young adults with Down syndrome.source ↗
  • May 6, 2022Phase changeAEF0117 (lixosicone)·Cannabis use disorderPhase 2Phase 2b SICA2 (NCT05322941) initiated; first patient dosed reported June 2022.source ↗

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    Leadership & advisors (12)