Alkermes has reported positive top-line findings from a Phase Ib proof-of-concept study of ALKS 7290, a new investigational orexin 2 receptor agonist, being developed for adults with attention-deficit hyperactivity disorder (ADHD).
The study assessed the tolerability, safety, pharmacodynamics, and pharmacokinetics in both healthy volunteers and adults with ADHD, with a focus on early signals of clinical effect.
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The therapy was generally well tolerated at all doses evaluated in the study, which enrolled 88 healthy volunteers and 50 adults with ADHD.
In the patient cohort, participants underwent a two-week washout period before being randomised to receive either 20mg or 50mg daily doses of ALKS 7290, administered in split doses, or placebo for a period of 14 days.
On exploratory endpoints, adults with ADHD treated with ALKS 7290 experienced dose-dependent and clinically meaningful improvements in symptom severity as measured by the Adult ADHD Investigator Symptom Rating Scale (AISRS) and Clinical Global Impression-Severity Scale (CGI-S) at day 14.
Median reductions from baseline were reported as 14.0 points for the 20mg group and 19.0 for the 50mg group on the AISRS. For the CGI-S, corresponding reductions were 1.0 and 2.0 points for the 20mg and 50mg dose groups, respectively.
Evaluation of electroencephalogram-based biomarkers and cognitive performance tests indicated that ALKS 7290 produced treatment effects across domains such as processing speed, working memory, and sustained attention.
Safety assessments found no serious treatment-emergent adverse events, and the majority of adverse events were mild.
The most frequently observed events included constipation, dizziness, insomnia, micturition urgency, pollakiuria, and change in sustained attention.
No participants receiving ALKS 7290 discontinued treatment, whereas two discontinuations occurred in the placebo group.
Alkermes chief medical officer and research and development executive vice-president Craig Hopkinson said: “Results from this Phase I study of ALKS 7290 represent an important milestone in the advancement of our orexin portfolio and support our strategy to explore the potential of orexin biology beyond hypersomnolence disorders.
“This exploratory, first-in-patient study was designed to provide early insights into the potential of orexin 2 receptor agonism as a novel treatment for adults with ADHD, and we are excited to see the emerging clinical profile of ALKS 7290.”
A Phase II trial assessing once-daily and split dosing of ALKS 7290 in adults with ADHD is currently enrolling, with a target of around 312 participants.
ALKS 7290 is designed to target the orexin system, which is implicated in regulation of wakefulness, attention, cognition, and mood.
In May, Alkermes reported positive top-line data from the Phase III REVITALYZ study, assessing the investigational use of extended-release Lumryz (sodium oxybate) oral suspension in adults with idiopathic hypersomnia.
