Alkermes' orexin 2 receptor agonist ALKS 7290 shows symptom reductions in Phase 1b ADHD trial
核心洞察
Alkermes reported that ALKS 7290 (搜索), an orexin 2 receptor (搜索) agonist, produced clinically meaningful improvements in ADHD symptoms in adults after 14 days of treatment.
In the double-blind, placebo-controlled Phase 1b study of 50 adults, median Adult ADHD Investigator Symptom Rating Scale scores fell 14.0 points at 20 mg and 19.0 points at 50 mg.
Alkermes said ALKS 7290 (搜索) is the first orexin 2 receptor (搜索) agonist to demonstrate clinically meaningful symptom improvements in adults with ADHD.
Alkermes reported positive Phase 1b results for ALKS 7290 (搜索), an investigational orexin 2 receptor (搜索) agonist for adults with attention-deficit hyperactivity disorder (搜索), with symptom improvements observed after 14 days of treatment. The company said the findings demonstrated clinical proof of concept and that ALKS 7290 is the first orexin 2 receptor agonist to show clinically meaningful improvements in ADHD symptoms in adults.
Orexin agonists have been recognized for their ability to treat rare sleep disorders. The new data represent the first indication that the drug class may also benefit people with ADHD.
Trial Design and Dosing
The double-blind, placebo-controlled Phase 1b study enrolled 50 adults with ADHD. Participants received ALKS 7290 (搜索) at total daily doses of either 20 mg or 50 mg, or placebo, over a 14-day treatment period. The trial assessed safety and tolerability alongside exploratory measures of change in ADHD symptoms from baseline. The drug was evaluated in both healthy volunteers and adults with ADHD.
Symptom Score Reductions
On the Adult ADHD Investigator Symptom Rating Scale, participants receiving ALKS 7290 (搜索) showed median symptom score reductions of 14.0 points at the 20 mg dose and 19.0 points at the 50 mg dose by day 14. The median baseline score was approximately 39 points, indicating moderate to severe symptoms. At the 50 mg dose, the 19-point reduction brought symptoms into the mild range.
The reported figures indicate improvements from baseline in both active-treatment groups. They do not establish the magnitude of the treatment effect relative to placebo.
ALKS 7290 (搜索) also produced improvements on the Clinical Global Impression-Severity Scale, which assesses the overall severity of a patient's condition. At day 14, median scores had declined by 1.0 point in the 20 mg group and 2.0 points in the 50 mg group. According to Alkermes, these changes corresponded to a reduction in symptom severity from markedly or moderately ill to mildly ill.
Safety and Tolerability
Alkermes reported no serious treatment-emergent adverse events during the study. Most adverse events were mild. The most frequently reported events included insomnia, increased urinary frequency, dizziness, changes in sustained attention, urinary urgency and constipation. Two participants in the placebo group discontinued the study, while no participants receiving ALKS 7290 (搜索) withdrew. The company said the drug was generally well tolerated at all doses tested.
Next Steps
Alkermes is currently enrolling patients in a Phase 2 study of ALKS 7290 (搜索) in adults with ADHD, with data expected in 2027. The next stage of development will evaluate the drug's efficacy and safety in a larger patient population and further investigate the Phase 1b findings. The company noted that larger and longer-duration studies will be needed to establish the drug's efficacy and safety.