Alkermes plc (NASDAQ: ALKS) reported exploratory positive data from a Phase 1b study of ALKS 7290, an investigational orexin 2 receptor agonist being developed for the treatment of attention-deficit hyperactivity disorder in adults.
The Phase 1 program evaluated safety, tolerability and pharmacokinetics across two groups: 88 healthy volunteers and 50 adults with ADHD. ALKS 7290 was generally well tolerated at all doses tested.
In the Phase 1b study, 50 adults with ADHD were randomized to receive either 20 mg or 50 mg of ALKS 7290 total daily dose or placebo for 14 days, following a two-week medication washout period. The study was not designed or powered to detect statistically significant differences between treatment groups.
On the Adult ADHD Investigator Symptom Rating Scale, a 54-point measure with a baseline median score of approximately 39, both doses demonstrated dose-dependent improvements by Day 14. The 20 mg dose yielded a median reduction of 14.0 points from baseline, while the 50 mg dose produced a median reduction of 19.0 points. On the Clinical Global Impression-Severity Scale, the 20 mg dose resulted in a median reduction of 1.0 and the 50 mg dose a reduction of 2.0.
The most common treatment-emergent adverse events were insomnia, pollakiuria, dizziness, change in sustained attention, micturition urgency and constipation. Most adverse events were mild in severity, and no serious treatment-emergent adverse events were reported. Two participants in the placebo group discontinued the study; no participants receiving ALKS 7290 discontinued.
Alkermes said a Phase 2 study evaluating ALKS 7290 in adults with ADHD is currently enrolling approximately 312 participants. The first participant was dosed in September 2026, and data is expected in 2027.
