Pharmaceutical company Indivior PLC (Nasdaq: INDV) (LSE: INDV) reported on Wednesday that the clinical Phase 2B study conducted by Aelis Farma on AEF0117, aimed at treating Cannabis Use Disorder (CUD), did not meet its primary or secondary endpoints. The trial, which included treatment-seeking participants with moderate to severe CUD, evaluated the efficacy of AEF0117 at dosages of 0.1, 0.3, and 1 mg once daily over 12 weeks.
The primary endpoint, reducing cannabis use to ≤1 day per week, and secondary endpoints, including complete abstinence or reduction to ≤2 days per week, were not achieved. These results highlight the ongoing challenges in treating severe CUD and the need for further research to better understand patient subpopulations.
As a result of the trial's outcomes and the lack of significant differentiation from placebo, Indivior does not currently plan to exercise its option to license the global rights to AEF0117 under its strategic collaboration with Aelis Farma.
Indivior, headquartered in Richmond, VA, is committed to developing treatments for substance use disorders (SUD) and related mental health conditions. Despite this setback, the company continues to focus on expanding its portfolio of treatments for opioid use disorder (OUD) and other chronic conditions associated with SUD. Indivior's products are available in over 30 countries, and the company employs more than 1,000 people worldwide.
Adicet Bio secures FDA Fast Track Designation for ADI-001 to treat refractory SLE
Acrivon Therapeutics receives FDA Breakthrough Device designation for ACR-368 OncoSignature assay
Vistagen secures US patent for AV-101 in neuropathic pain treatment
Thermo Fisher Scientific launches international registry for adolescent alopecia areata
hVIVO successfully completes RSV antiviral trial for Shionogi
Valneva secures UK approval for world's first chikungunya vaccine
Alys Pharmaceuticals' IND for ALY-101 approved in US and Canada
NeuroTherapia's Phase 2 Alzheimer's disease trial receives European regulatory approval
NFL Biosciences confirms superior safety profile of NFL-101 in new toxicity study
Avirmax Biopharma completes first cohort of Wet AMD clinical trial
PhaseV collaborates with Alimentiv to address challenges in GI clinical trials
HOPE Therapeutics and NRx Pharmaceuticals select BTIG as financial advisor
Helix unveils clinico-genomic dataset of over 15,000 patients treated with GLP-1 agonists
Roquefort Therapeutics sells Lyramid for USD10.8m equity deal with Pleiades Pharma