AEF0117 / Aelis Farma, Indivior - LARVOL DELTA

Aelis Farma Announces the Final Analysis of the Landmark Phase 2B Clinical Trial in Cannabis Use Disorder (CUD) with the CB1-SSi AEF0117 (Businesswire) - P2 | N=333 | NCT05322941 | Sponsor: Aelis Farma | "AEF0117 was well-tolerated with no safety concerns identified, notably, AEF0117 did not cause the psychiatric side effects...In the overall study population, the highest dose of AEF0117 (1mg) induced a non-statistically significant increase in the proportion of responders (+100% vs placebo) reaching the primary endpoint (cannabis use ≤1 day per week) and achieving abstinence (+200%); In the subgroup of patients (24%) with a high commitment to quit their cannabis use (measured by the Motivation to quit ladder), the effects of AEF0117 1mg were amplified for the primary (cannabis use ≤1 day per week) and secondary (abstinence and cannabis use ≤2 days per week) qualitative endpoints (+228% vs placebo in all cases) and for the number of days of cannabis use (-55% vs placebo; P=0.038) as well as for the amount of cannabis smoked per day (-76% vs placebo; P=0.029)."

P2b data • Substance Abuse

DDI: Drug-Drug Interaction Between THC and AEF0117 (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Aelis Farma | Trial completion date: Feb 2025 ➔ Jun 2025 | Trial primary completion date: Feb 2025 ➔ Jun 2025

Trial completion date • Trial primary completion date

DDI: Drug-Drug Interaction Between THC and AEF0117 (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Aelis Farma | Initiation date: Sep 2024 ➔ Dec 2024

Trial initiation date

DDI: Drug-Drug Interaction Between THC and AEF0117 (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Aelis Farma | Trial completion date: Oct 2024 ➔ Jan 2025 | Initiation date: Jun 2024 ➔ Sep 2024 | Trial primary completion date: Oct 2024 ➔ Jan 2025

Trial completion date • Trial initiation date • Trial primary completion date

SICA 2: Effect of AEF0117 on Treatment-seeking Patients With Cannabis Use Disorder (CUD) (clinicaltrials.gov) - P2 | N=333 | Completed | Sponsor: Aelis Farma | Active, not recruiting ➔ Completed

Trial completion • Substance Abuse

The Effect of Food on the Oral Bioavailability of AEF0117 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=24 | Terminated | Sponsor: Aelis Farma | Active, not recruiting ➔ Terminated; Study was initially paused due to a research hold of the institution. However, the study will not continue as the sample size of patients collected prior to the pause allowed for adequate data analysis of the study endpoints.

Trial termination • Substance Abuse

DDI: Drug-Drug Interaction Between THC and AEF0117 (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Aelis Farma

New P1 trial

The Effect of Food on the Oral Bioavailability of AEF0117 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=32 | Active, not recruiting | Sponsor: Aelis Farma | Trial completion date: Mar 2024 ➔ Jun 2024 | Trial primary completion date: Mar 2024 ➔ Jun 2024

Trial completion date • Trial primary completion date • Substance Abuse

The Effect of Food on the Oral Bioavailability of AEF0117 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=32 | Active, not recruiting | Sponsor: Aelis Farma | Recruiting ➔ Active, not recruiting | Trial primary completion date: Aug 2023 ➔ Feb 2024

Enrollment closed • Trial primary completion date • Substance Abuse

Effect of AEF0117 on Treatment-seeking Patients With Cannabis Use Disorder (CUD): SICA 2: SPECIFIC SIGNALING INHIBITOR IN CANNABIS ADDICTION (clinicaltrials.gov) - P2 | N=330 | Active, not recruiting | Sponsor: Aelis Farma | Recruiting ➔ Active, not recruiting | Phase classification: P2b ➔ P2 | Trial completion date: Nov 2023 ➔ Apr 2024 | Trial primary completion date: Aug 2023 ➔ Apr 2024

Enrollment closed • Phase classification • Trial completion date • Trial primary completion date • CNS Disorders • Psychiatry • Substance Abuse

Signaling-specific inhibition of the CB receptor for cannabis use disorder: phase 1 and phase 2a randomized trials. (PubMed, Nat Med) - P1, P2 | "In volunteers with CUD, AEF0117 was well tolerated and did not precipitate cannabis withdrawal. These data suggest that AEF0117 is a safe and potentially efficacious treatment for CUD.ClinicalTrials.gov identifiers: NCT03325595 , NCT03443895 and NCT03717272 ."

Journal • P1 data • P2a data • Substance Abuse

The Effect of Food on the Oral Bioavailability of AEF0117 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Aelis Farma | Trial completion date: Jun 2023 ➔ Dec 2023 | Trial primary completion date: May 2023 ➔ Aug 2023

Trial completion date • Trial primary completion date • Substance Abuse

Study of [4-14C] AEF0117 Following a Single Oral Dose in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: Aelis Farma | Active, not recruiting ➔ Completed | Trial completion date: Aug 2023 ➔ Feb 2023

Trial completion • Trial completion date • Substance Abuse

Study of [4-14C] AEF0117 Following a Single Oral Dose in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=8 | Active, not recruiting | Sponsor: Aelis Farma | Recruiting ➔ Active, not recruiting

Enrollment closed • Substance Abuse

The Effect of Food on the Oral Bioavailability of AEF0117 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Aelis Farma | Not yet recruiting ➔ Recruiting

Enrollment open • Substance Abuse

Study of [4-14C] AEF0117 Following a Single Oral Dose in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=8 | Recruiting | Sponsor: Aelis Farma | Not yet recruiting ➔ Recruiting

Enrollment open • Substance Abuse

Clinical Research on Novel Pharmacologic and Immunologic Approaches to Treating Cannabis Use Disorder and Opioid Use Disorder (ACNP 2022) - "Haney will present Phase 1-2a studies testing the pregnenolone analogue, AEF0117, a signaling specific inhibitor of the cannabinoid type 1 receptor...D’Souza, will describe findings from a near-completed multi-site Phase 2b trial testing the effects of PF-04457845, an orally active, longacting, potent, and selective inhibitor of fatty acid amide hydrolase (FAAH), the primary enzyme degrading the endocannabinoid, anandamide...Comer will present the safety, immunogenicity, and preliminary efficacy data from a Phase 1a/1b study to evaluate an opioid vaccine targeting oxycodone in non-treatment-seeking participants with OUD, as well as preclinical data that were used to support the clinical research. Snyder will present unpublished data describing the preclinical pharmacological profile of ITI-333 in animal models of opioid withdrawal and craving and the clinical translation of ITI-333 into Phase I SAD study."

Clinical • Addiction (Opioid and Alcohol) • Substance Abuse

Effect of AEF0117, a Signaling-Specific Inhibitor of the CB1 Receptor, on the Reinforcing and Subjective Effects of Smoked Cannabis (ACNP 2022) - "Conclusions AEF0117 safely and robustly attenuated the positive subjective and reinforcing effects of cannabis in participants with CUD. Favorable pharmacokinetic and safety profiles combined with the human laboratory data support an upcoming Phase 2b, placebo-controlled multi-site clinical trial testing AEF0117 in patients seeking treatment for CUD."

Clinical • Substance Abuse

Study of [4-14C] AEF0117 Following a Single Oral Dose in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: Aelis Farma

New P1 trial • Substance Abuse

The Effect of Food on the Oral Bioavailability of AEF0117 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Aelis Farma

New P1 trial • Substance Abuse

Effect of AEF0117 on Treatment-seeking Patients With Cannabis Use Disorder (CUD): SICA 2: SPECIFIC SIGNALING INHIBITOR IN CANNABIS ADDICTION (clinicaltrials.gov) - P2b | N=330 | Recruiting | Sponsor: Aelis Farma | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Psychiatry • Substance Abuse

Effect of AEF0117 on Treatment-seeking Patients With Cannabis Use Disorder (CUD): SICA 2: SPECIFIC SIGNALING INHIBITOR IN CANNABIS ADDICTION (clinicaltrials.gov) - P2b | N=330 | Not yet recruiting | Sponsor: Aelis Farma

New P2b trial • CNS Disorders • Psychiatry • Substance Abuse

Effect of AEF0117 on Subjective Effects of Cannabis in CUD Subjects (clinicaltrials.gov) - P2; N=29; Completed; Sponsor: Aelis Farma; Active, not recruiting ➔ Completed; N=48 ➔ 29; Trial completion date: Jul 2020 ➔ Jan 2021

Clinical • Enrollment change • Trial completion • Trial completion date • Substance Abuse

Effect of AEF0117 on Subjective Effects of Cannabis in CUD Subjects (clinicaltrials.gov) - P2; N=48; Active, not recruiting; Sponsor: Aelis Farma; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed