Alkermes Positive Phase 1b Results for Clinical Proof-of-Concept for ALKS 7290 in ADHD

 ALKS 7290 is the First Orexin 2 Receptor Agonist to Demonstrate Clinically Meaningful Improvements in ADHD Symptoms in Adults —

— ALKS 7290 Was Generally Well Tolerated at All Doses Tested in Healthy Volunteers and Adults With ADHD —

— Phase 2 Study of ALKS 7290 in Adults With ADHD is Enrolling, Data Expected in 2027 —

Alkermes plc (Nasdaq: ALKS) today announced positive topline results from a phase 1 proof-of-concept study evaluating ALKS 7290, the company’s novel, investigational orexin 2 receptor (OX2R) agonist in development for the treatment of attention-deficit hyperactivity disorder (ADHD). The study evaluated the safety and tolerability (primary objective) and pharmacokinetics (PK) and pharmacodynamics (PD) of ALKS 7290 in healthy volunteers (n=88) and in adults with ADHD (n=50). In the phase 1 study, ALKS 7290 was generally well tolerated at all doses tested in healthy volunteers and adults with ADHD. In adult participants with ADHD, ALKS 7290 demonstrated dose-dependent, clinically meaningful improvements on exploratory endpoints evaluating change from baseline on established clinical scales, the Adult ADHD Investigator Symptom Rating Scale (AISRS) and Clinical Global Impression-Severity Scale (CGI-S), at day 14 of treatment. These findings represent the first clinical evidence of the effects of an orexin receptor agonist in the treatment of ADHD and further support the dose range selected for the ongoing phase 2 study evaluating the efficacy and safety of ALKS 7290 in adults with ADHD.

The phase 1b study enrolled 50 adults with ADHD in a double-blind, placebo-controlled, parallel-group trial with two cohorts. Following a two-week washout of existing ADHD medications, participants were randomized (4:1, active:placebo) within each cohort to receive ALKS 7290 (total daily dose of 20 mg (n=20) or 50 mg (n=20), administered in split doses) or placebo (n=10) for 14 days of inpatient treatment. In addition to safety, tolerability and PK and PD effects, the study evaluated change from baseline across a range of exploratory endpoints to begin to characterize the effects of ALKS 7290 on symptoms of ADHD. The study was not designed or powered to detect statistically significant differences between treatment groups.

https://www.biospace.com/press-releases/alkermes-announces-positive-phase-1b-results-demonstrating-clinical-proof-of-concept-for-alks-7290-in-adults-with-attention-deficit-hyperactivity-disorder-adhd