Alkermes Reports Promising Findings from Vibrance-2 Study of Alixorexton for Narcolepsy Type 2

Alkermes Unveils Promising Outcomes from Vibrance-2 Phase 2 Study

Alkermes plc has recently shared encouraging topline results from its Vibrance-2 phase 2 study, exploring the efficacy of Alixorexton, a novel oral orexin 2 receptor agonist, in participants suffering from Narcolepsy Type 2 (NT2). This marks a significant milestone as Alixorexton is the first medication of its kind to show effectiveness in a large-scale phase 2 clinical trial for individuals with this challenging condition.

Key Findings from the Study

The Vibrance-2 study randomized 93 participants suffering from NT2 to receive either Alixorexton or a placebo over an eight-week period. The results demonstrated significant improvements compared to the placebo group on two primary endpoints: the Maintenance of Wakefulness Test (MWT) and the Epworth Sleepiness Scale (ESS).

Clinical Significance

Participants receiving Alixorexton exhibited meaningful enhancements in wakefulness and reductions in excessive daytime sleepiness, both critical aspects of managing narcolepsy symptoms. For instance, those on the 14 mg and 18 mg doses showed statistically significant improvements in their mean sleep latency on the MWT. Meanwhile, improvements on the ESS reflected a notable decrease in daytime sleepiness for patients at the 18 mg dosage, reinforcing its potential as an effective therapeutic option.

Safety Profile

Alixorexton demonstrated a favorable safety profile throughout the treatment period, with most adverse events being classified as mild to moderate in severity. Notably, there were no serious treatment-emergent adverse events reported, and no concerning safety signals were noted in vital signs or renal and hepatic function tests. Common side effects in participants included pollakiuria, insomnia, dizziness, and headaches, but the overall tolerability of the drug was commendable, with approximately 95% of participants completing the trial.

The Bigger Picture

The findings from Vibrance-2 are particularly promising, as NT2 is characterized by varied symptom severity and treatment responses, with many patients having normal orexin levels. Historically, treatments focused on orexin deficiency have not addressed the broader spectrum of symptoms seen in narcolepsy patients effectively.

Dr. Emmanuel Mignot, an expert in sleep medicine, highlighted the importance of these results, noting that they represent a breakthrough for a patient population in need of effective treatment options. Craig Hopkinson, Chief Medical Officer at Alkermes, reiterated that the vibrancy of these findings signifies a crucial advance not just for their drug development program but for the narcolepsy community nationwide.

Next Steps for Alixorexton

Looking ahead, Alkermes plans to initiate a global phase 3 program for Alixorexton starting in early 2026, further exploring its potential as a once-daily treatment. The company is expected to present detailed findings at upcoming scientific meetings, including patient-reported outcomes on fatigue and cognition.

In conclusion, the Vibrance-2 study results are an important advancement in the understanding and treatment of narcolepsy, offering hope to many patients suffering from this debilitating condition. As the research progresses, there is a renewed sense of optimism for these individuals who often face significant challenges in their daily lives due to excessive sleepiness and interruptions in their sleep-wake cycle.