Alkermes Shares Rise 6.5% After Positive Phase 1b Results for ADHD Drug ALKS 7290

Alkermes plc (NASDAQ:ALKS) shares gained 6.5% on Monday after the company reported positive Phase 1b clinical trial results for ALKS 7290, an investigational treatment for adults with attention-deficit hyperactivity disorder (ADHD).

The company said the findings demonstrated clinical proof of concept, with improvements in ADHD symptoms observed after 14 days of treatment.

According to Alkermes, ALKS 7290 is the first orexin 2 receptor agonist to demonstrate clinically meaningful improvements in ADHD symptoms in adults.

The drug was generally well tolerated across the doses evaluated in both healthy volunteers and adults with ADHD.

Phase 1b Trial Evaluates Two Doses of ALKS 7290

The double-blind, placebo-controlled study enrolled 50 adults with ADHD.

Participants received ALKS 7290 at total daily doses of either 20 mg or 50 mg, or a placebo, over a 14-day treatment period.

The trial assessed safety and tolerability alongside exploratory measures of changes in ADHD symptoms from baseline.

On the Adult ADHD Investigator Symptom Rating Scale, participants receiving ALKS 7290 demonstrated 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.

These results indicate improvements from baseline in both active-treatment groups. The reported figures do not, however, establish the magnitude of the treatment effect relative to placebo.

Improvements Also Recorded in Clinical Severity Scores

ALKS 7290 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.

The findings provide preliminary evidence supporting further investigation of the drug, although larger and longer-duration studies will be needed to establish its efficacy and safety.

No Serious Treatment-Emergent Adverse Events Reported

Alkermes reported no serious treatment-emergent adverse events during the study.

Most adverse events were mild. The most frequently reported 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 withdrew.

The company said the drug was generally well tolerated at all doses tested.

Phase 2 Study Underway With Results Expected in 2027

Alkermes is currently enrolling patients in a Phase 2 study of ALKS 7290 in adults with ADHD.

Data from that trial are expected in 2027.

The next stage of development will provide an opportunity to evaluate the drug’s efficacy and safety in a larger patient population and further investigate the findings from the Phase 1b programme.

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