Alkermes reported encouraging top‑line Phase Ib results for ALKS 7290, an orexin‑2 receptor agonist being studied for adults with ADHD. In a trial of 88 healthy volunteers and 50 patients, ALKS 7290 was generally well tolerated and produced dose‑dependent symptom improvements at day 14 (AISRS median reductions: 14.0 for 20 mg, 19.0 for 50 mg). EEG biomarkers and cognitive tests suggested benefits in processing speed, working memory and sustained attention. A larger Phase II study of roughly 312 participants is now recruiting.
Alkermes' ALKS 7290 Delivers Promising, Dose‑Dependent ADHD Signals in Phase Ib Trial
Adults with ADHD treated with ALKS 7290 experienced dose-dependent
Alkermes has reported positive top-line results from a Phase Ib proof-of-concept trial of ALKS 7290, an investigational orexin‑2 receptor agonist being developed for adults with attention‑deficit/hyperactivity disorder (ADHD).
Study Design
The randomized study evaluated tolerability, safety, pharmacodynamics and pharmacokinetics in 88 healthy volunteers and 50 adults with ADHD. Patients completed a two‑week medication washout before randomization to receive either 20 mg or 50 mg per day (administered in split doses) or placebo for 14 days.
Clinical Signals
On exploratory endpoints at day 14, ALKS 7290 produced dose‑dependent, clinically meaningful improvements in ADHD symptoms. Median reductions from baseline on the Adult ADHD Investigator Symptom Rating Scale (AISRS) were 14.0 points for the 20 mg group and 19.0 points for the 50 mg group. Corresponding median improvements on the Clinical Global Impression–Severity scale (CGI‑S) were 1.0 and 2.0 points, respectively.
Biomarkers and Cognitive Effects
Electroencephalogram (EEG)–based biomarker assessments and cognitive performance testing indicated treatment effects across processing speed, working memory and sustained attention, supporting pharmacodynamic activity consistent with orexin‑2 receptor agonism.
Safety
ALKS 7290 was generally well tolerated across doses. There were no serious treatment‑emergent adverse events and the majority of adverse events were mild. The most frequently reported events included constipation, dizziness, insomnia, urinary urgency (micturition urgency and pollakiuria) and changes in sustained attention. No participants receiving ALKS 7290 discontinued treatment; there were two discontinuations in the placebo arm.
Craig Hopkinson, Chief Medical Officer and Executive Vice‑President for Research and Development at Alkermes, 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 evaluating once‑daily and split dosing of ALKS 7290 in adults with ADHD is currently enrolling, with a planned enrollment of approximately 312 participants. ALKS 7290 targets the orexin system, which is implicated in the regulation of wakefulness, attention, cognition and mood.
In May, Alkermes also reported positive top‑line data from the Phase III REVITALYZ study of extended‑release Lumryz (sodium oxybate) oral suspension in adults with idiopathic hypersomnia.
Reporting based on a Clinical Trials Arena article published by GlobalData.
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