Newleos Therapeutics has dosed the first participant in its Phase Ib clinical study evaluating NTX-2001, a partial agonist of trace amine-associated receptor 1 (TAAR1), for alcohol use disorder (AUD).
The double-blind, placebo-controlled, randomised trial is being conducted in collaboration with Yale School of Medicine.
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It is assessing reductions in alcohol consumption, cravings, tolerability, pharmacokinetics, and safety of NTX-2001 in individuals with AUD.
The initiation of the Phase Ib trial follows substantial preclinical and clinical data supporting the TAAR1 mechanism and NTX-2001.
The therapy has previously been studied across eight trials in healthy participants and those with schizophrenia or schizoaffective disorder, involving around 645 participants.
These studies assessed efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics. NTX-2001 was consistently found to be safe and well-tolerated.
Recruitment is ongoing for participants aged 21 to 60 years with a current AUD diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria, confirmed by the Mini-International Neuropsychiatric Interview (MINI).
Participants are randomised to receive NTX-2001 or a placebo daily for around two weeks within a ten-week study period, which includes screening and follow-up, and visiting the clinic four times.
The primary endpoint is the number of drinks consumed during an alcohol drinking paradigm (ADP), with secondary endpoints covering adverse events, vital signs, and laboratory tests.
NTX-2001 is a selective partial agonist of TAAR1, a G protein-coupled receptor found in brain regions that modulate dopaminergic circuits linked to reward and satiety.
The ongoing proof-of-concept study in the US utilises the ADP to model drinking behaviour and evaluates NTX-2001’s safety, tolerability, and pharmacokinetics.
Newleos co-founder and chief medical officer Federico Bolognani said: “As the first time a TAAR1 partial agonist has been evaluated in the clinic for alcohol use disorder, this study of NTX-2001 represents an important milestone for Newleos and for the field of addiction medicine.
“Because addiction almost always involves dopamine dysregulation, success in this Phase Ib study would also be a critical first step in the development of a drug that could treat a wider array of addictive disorders.”
