Alkermes (NASDAQ:ALKS) executives said the company is entering a period of heightened execution as it advances its orexin agonist program into late-stage development, integrates Avadel and prepares for a planned leadership transition.
Speaking at the Goldman Sachs Global Healthcare Conference, Chairman and Chief Executive Officer Richard Pops said the past year has been “fantastically interesting” for Alkermes, citing progress in orexin agonists, the company’s acquisition of Avadel and the planned move that will see him transition to chairman while Chief Operating Officer Blair Jackson takes over as CEO.
Alixorexton Moves Into Phase 3
Jackson said Alkermes is now enrolling its Phase 3 Brilliance program for alixorexton, which includes two studies in narcolepsy type 1, or NT1, and one study in narcolepsy type 2, or NT2. The studies include both once-daily dosing and split dosing, which Jackson said could give physicians and patients flexibility across different disease presentations.
Jackson said the company is seeing a “tremendous response” from patients and physicians as Phase 3 enrollment begins, adding that Alkermes is “exactly where we had hoped to be” at this stage. He said European sites are coming online on a country-by-country basis and noted that some of the company’s strongest sites are outside the United States.
Pops said the company’s large Phase 2 program has helped prepare for Phase 3 because physicians can now discuss the trial with patients using an existing safety and efficacy data set. “The virtue of running a big phase II program is that it prepares you for phase III,” Pops said.
Executives Highlight Differentiation in Orexin Class
Jackson said Alkermes aims to differentiate alixorexton through a broad product profile, including multiple doses, once-daily and split-dose regimens, and potential use across NT1, NT2 and idiopathic hypersomnia. He contrasted that with Takeda’s orexin agonist, which he described as a “wonderful drug” but one that he said is more limited in dosing and indication breadth.
“Our goal with our TPP is to create a label that’s going to be hard for anyone else coming behind us to differentiate from,” Jackson said, referring to the target product profile.
Asked about the potential impact of a Takeda launch in NT1, Jackson said he does not expect it to materially affect Alkermes’ enrollment. Pops added that Alkermes would be “the biggest fans” of a strong Takeda launch if it helps educate patients and physicians about the orexin mechanism.
Additional Data Expected at SLEEP Conference
Pops said Alkermes plans to present a more complete analysis of its NT2 data at the SLEEP conference in Baltimore. He said the company will show longer-term extension data from the open-label phase, including durability over multiple weeks and new data on fatigue and cognition.
Jackson said the company has seen improvements in cognition and fatigue in its orexin agonist studies, including movement from severe baseline symptoms toward normalization over the study period. He said Alkermes views measures such as cognition and fatigue as important because patients with narcolepsy often describe their condition in terms of “brain fog” and fatigue, rather than clinical endpoints such as the Maintenance of Wakefulness Test, or MWT.
Jackson also said Alkermes will show data on cognition and fatigue over the course of the study and open-label extension, including responses among patients who switched from placebo to active drug.
On safety, Jackson said the open-label data are expected to show consistent tolerability. He cited transient insomnia and polyuria as adverse events that can occur but said they do not appear to emerge frequently during longer-term treatment. He also said ophthalmic exams, which were conducted in Phase 2 after vision-related adverse events, will not be part of Phase 3.
Idiopathic Hypersomnia and ADHD Programs Advance
Jackson said Alkermes is also enrolling a split-dose cohort in its ongoing Phase 2 study in idiopathic hypersomnia, with completion expected in the fourth quarter. He said disclosures from that program are expected to be similar to the company’s NT2 updates, but with the addition of split dosing. The endpoints for idiopathic hypersomnia include the Epworth Sleepiness Scale and the Idiopathic Hypersomnia Severity Scale, while MWT is also being collected.
Alkermes is also advancing Project Saturn, including ALKS 7290 in ADHD. Jackson said the company expects a Phase 1b study in ADHD patients in the fourth quarter and is preparing a Phase 2 dose-ranging study later this summer. He said the Phase 2 study is expected to include 300 patients and use the ACE-R test as a statistical measure.
Jackson said ADHD is, in Alkermes’ view, the most proximate opportunity for orexin agonism beyond sleep disorders, but emphasized that the company wants to explore whether the mechanism can provide benefits beyond existing ADHD therapies, including potential effects on cognition and fatigue.
Avadel Integration and CEO Transition
Jackson said the Avadel transaction has closed and has brought Alkermes the LUMRYZ oxybate asset, a commercial team experienced in sleep medicine and added preparation for a potential alixorexton launch. He said more than 90% of Avadel’s commercial business came over to Alkermes and is “pretty much integrated.”
Jackson said the acquisition gives Alkermes established relationships with physicians, nurses, payers and treatment centers in sleep medicine, which he said could help the company prepare for alixorexton if approved.
Pops, who is set to move into the chairman role in August after more than three decades with the company, said he is most proud that more than 200,000 patients are expected to receive Alkermes medicines this year. He pointed to the company’s work in serious mental illness and addiction, areas he said have not always received significant attention from larger pharmaceutical companies.
“If you can spend your professional energies doing things like that, at the end of the day, if you’re successful and it’s hard, it translates into people’s lives getting better,” Pops said. He added that he expects the transition to Jackson to occur “without a hitch.”
About Alkermes (NASDAQ:ALKS)
Alkermes plc is a biopharmaceutical company focused on developing innovative medicines to address unmet needs in the central nervous system (CNS). The company applies its proprietary drug delivery technologies and therapeutic expertise to advance treatments for addiction, schizophrenia, bipolar I disorder and depression. Alkermes’ portfolio includes both commercial products and a pipeline of investigational therapies designed to improve patient outcomes and support long-term disease management.
Alkermes’ commercial franchise features several approved products.
