Alkermes plc (NASDAQ:ALKS) on Monday released topline results from the randomized double-blind treatment period of the Vibrance-1 phase 2 study evaluating alixorexton in patients with narcolepsy type 1 (NT1).
Narcolepsy is a chronic neurological disorder that disrupts the body’s ability to regulate sleep-wake cycles. It’s characterized by excessive daytime sleepiness and sudden, uncontrollable sleep attacks.
Alixorexton, formerly ALKS 2680, is an investigational, oral orexin 2 receptor (OX2R) agonist in phase 2 development as a once-daily treatment for NT1, narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH).
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In Vibrance-1, alixorexton met the primary endpoint across all doses tested, demonstrating statistically significant, clinically meaningful, and dose-dependent improvements in wakefulness on the Maintenance of Wakefulness Test (MWT) from baseline compared to placebo.
In addition to achieving normative wakefulness across all dose groups on the MWT (mean sleep latency >20 minutes), once-daily alixorexton demonstrated robust and clinically meaningful improvements compared to placebo on patient-reported outcomes related to excessive daytime sleepiness and other key symptoms such as fatigue and cognition.
Alixorexton was generally well tolerated at all doses tested. These data support rapid initiation of a global phase 3 program of alixorexton in patients with NT1.
Key Secondary Endpoints
Epworth Sleepiness Scale (ESS): At all doses tested, alixorexton drove statistically significant and clinically meaningful improvements from baseline in excessive daytime sleepiness compared to placebo on the Epworth Sleepiness Scale at week six (p<0.0001 at all doses).
Weekly Cataplexy Rates (WCR): Alixorexton numerically improved weekly cataplexy rates across all doses compared to placebo at week six and achieved statistical significance at the 6 mg dose (p=0.005).
Alixorexton demonstrated consistent and clinically meaningful improvements across several patient-reported outcome measures of symptoms important to patients, including:
Narcolepsy Severity Scale (NSS): Across all doses tested, alixorexton demonstrated clinically meaningful improvements from baseline in narcolepsy symptom severity as compared to placebo at week six (p<0.001 at all doses).
British Columbia Cognitive Complaints Inventory (BC-CCI): Across all doses tested, alixorexton demonstrated clinically meaningful improvements from baseline in cognitive complaints compared to placebo at week six (p<0.0001 at all doses).
PROMIS (Patient-Reported Outcomes Measurement Information System)-Fatigue: Across all doses tested, alixorexton demonstrated clinically meaningful improvements from baseline in fatigue as compared to placebo at week six (p<0.01 at all doses).
Alixorexton was generally well tolerated across all doses tested in the randomized double-blind period of the Vibrance-1 study.
No treatment-emergent serious adverse events (TEAEs) were reported. Most TEAEs were mild to moderate in severity and generally consistent with the events observed across the Alixorexton phase 1 program in healthy volunteers and patients.
No treatment-related safety signals were observed in hepatic and renal parameters, vital signs, or ophthalmic exams.
Vibrance-2 and Vibrance-3, phase 2 studies evaluating the safety and efficacy of alixorexton in adults with NT2 and IH, respectively, are ongoing.
In April 2024, Alkermes revealed topline results from the narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH) cohorts of a phase 1b, proof-of-concept study evaluating ALKS 2680 for narcolepsy.
ALKS 2680 data demonstrated clinically meaningful and statistically significant improvements from baseline in mean sleep latency on the Maintenance of Wakefulness Test compared to placebo at all doses tested.
Price Action: ALKS stock is trading lower by 7.24% to $27.11 at last check Monday.
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