Alkermes Plc (ALKS) recently announced positive topline data from its Phase II Vibrance-1 trial of alixorexton (formerly ALKS 2680) in patients with narcolepsy type 1 (NT1). The Vibrance-1 trial is a global, randomized, double-blind, placebo-controlled multiple dose trial, notes John McCamant, editor of Medical Technology Stock Letter.
Patients (n=92) were randomized 1:1:1:1 to receive treatment with either alixorexton at one of four dose levels (4mg, 6mg, or 8mg, all administered QD) or placebo for a six-week treatment period. Overall, we are encouraged by the totality of alixorexton’s efficacy data in this larger patient set (92 versus 10 patients in the prior Phase Ib).
Alkermes Plc (ALKS)
Alixorexton demonstrated statistically significant and clinically meaningful improvements on patients’ sleep latency (per the MWT, where wakefulness above the normative range of 20 minutes was achieved) and self-reported subjective sleepiness (per ESS) at all doses. We look forward to full details at the World Sleep Conference (Sept. 5-10) to better understand the totality of alixorexton’s clinical profile and ensuing commercial opportunity.
Importantly, the safety data showed alixorexton to be generally well-tolerated among patients across all doses tested (no treatment-related SAEs reported, and most TEAEs mild to moderate in severity). No treatment-related safety signals were observed in hepatic and renal parameters, vital signs, or ophthalmic exams.
Plus, over 95% of patients who participated in the six-week double-blind portion of the study continued on to the ongoing seven-week open-label extension, which we find to be encouraging. There were limited details around visual disturbances, which have been a key point of debate for investors.
Recommended Action: Buy ALKS.
