Axsome Presents Q1 Results, Advances in Sleep Medicine Pipeline

Summary: Axsome Therapeutics’ Q1 2024 report highlights advancements in its sleep medicine pipeline, with positive phase 3 results for AXS-12 in narcolepsy treatment and revenue growth for Sunosi, reflecting strong financial performance and progress in addressing sleep disorders. Additionally, the company showcases promising developments in its neuroscience portfolio, including ongoing clinical trials for solriamfetol in ADHD, major depressive disorder, binge eating disorder, and shift work disorder.

Key Takeaways:

• Axsome Therapeutics reported robust financial results for Q1 2024, with total net product revenue reaching $75 million, marking 160% year-over-year growth. Sunosi, a key product in Axsome’s commercial portfolio, contributed to this growth with a revenue increase of 64% compared to the previous year.
• The company showcased progress in its sleep medicine pipeline, particularly with the announcement of positive phase 3 results for AXS-12 in narcolepsy treatment.
• Axsome is actively advancing its neuroscience portfolio, with the ongoing development of solriamfetol for various disorders, including shift work disorder.

Axsome Therapeutics announced its first quarter 2024 business highlights and financial outcomes, showcasing advancements in its sleep medicine portfolio, including positive phase 3 results for AXS-12 in narcolepsy treatment and revenue growth for Sunosi.

Sunosi is approved to treat wakefulness for excessive daytime sleepiness due to obstructive sleep apnea or narcolepsy.

“The first quarter was marked by strong financial performance for our on-market products which are delivering important and differentiated treatment options for patients living with depression, narcolepsy, and obstructive sleep apnea,” says Herriot Tabuteau, MD, CEO of Axsome Therapeutics, in a release. “We also significantly advanced our innovative neuroscience pipeline in the quarter. We announced positive phase 3 results for AXS-12 in narcolepsy, a major step toward making this new medicine available to patients living with this debilitating condition.”

First quarter 2024 financial highlights:

• Total net product revenue for the first quarter of 2024 was $75 million, representing 160% year-over-year growth. Total net product revenue for the comparable period in 2023 was $28.8 million. Overall total revenue for the first quarter of 2023 was $94.6 million which included a one-time $65.7 million upfront payment received for the out-licensing of Sunosi commercialization rights in Europe and certain countries in the Middle East and North Africa region.
• Sunosi net product revenue was $21.6 million for the first quarter of 2024, consisting of $20.7 million in net product sales and $0.9 million in royalty revenue associated with sales in out-licensed territories, representing 64% year-over-year growth. Sunosi net product revenue for the comparable period in 2023 was $13.2 million, consisting of $12.9 million in net product sales and $0.3 million in royalty revenue.

Commercial highlights for Sunosi:

• Approximately 42,000 prescriptions were written for Sunosi in the US in the first quarter of 2024, representing a 1.6% decrease versus the fourth quarter of 2023.
• Sunosi maintains broad payer coverage in the commercial channel with 95% of lives covered. Currently 83% of total lives across all channels are covered.

Axsome’s Sleep Medicine Development Pipeline

Axsome is advancing its neuroscience portfolio encompassing five late-stage, patent-protected product candidates for 10 psychiatric and neurologic conditions, which affect more than 150 million people in the US alone. Recent and anticipated progress for key pipeline programs in sleep medicine is summarized below.

AXS-12

AXS-12 (reboxetine) is Axsome’s novel, oral, potent, investigational highly selective norepinephrine reuptake inhibitor and cortical dopamine modulator for the treatment of narcolepsy. AXS-12 has been granted US Food and Drug Administration Orphan Drug designation for the treatment of narcolepsy.

• Narcolepsy: In March 2024, Axsome announced positive topline results from the SYMPHONY trial, a phase 3, randomized, double-blind, multicenter, placebo-controlled trial of AXS-12 in patients with narcolepsy. AXS-12 achieved the primary endpoint by significantly reducing the frequency of cataplexy attacks as compared to placebo in patients with narcolepsy. AXS-12 also reduced excessive daytime sleepiness severity, improved cognitive function, reduced overall narcolepsy severity, and improved patient function and quality of life, as compared to placebo. AXS-12 was well tolerated in the trial.
• A phase 3 open-label safety extension trial of AXS-12 is currently ongoing with completion anticipated in the fourth quarter of 2024.
• In March 2024, the company also announced topline results from the CRESCENDO (Characterizing Patient Perspectives on Unmet Needs in Narcolepsy) survey of 203 narcolepsy patients with cataplexy (narcolepsy type 1) who are currently receiving treatment. The results demonstrated high rates of persistent symptoms with 77%, 64%, and 74% continuing to experience cataplexy, excessive daytime sleepiness, and cognitive impairment, respectively, despite being on current treatments. CRESCENDO was conducted by a third-party research firm that worked with Narcolepsy Network to ensure patient privacy. Narcolepsy Network is a national non-profit patient support organization for people with narcolepsy, idiopathic hypersomnia and related sleep disorders.

Solriamfetol

Solriamfetol is Axsome’s dopamine and norepinephrine reuptake inhibitor and TAAR1 agonist in development for the treatment of attention deficit hyperactivity disorder (ADHD), major depressive disorder, binge eating disorder, and excessive sleepiness associated with shift work disorder.

• Shift work disorder: The company is on track to initiate a phase 3 trial of solriamfetol for the treatment of excessive sleepiness associated with shift work disorder in the second quarter of 2024.
• ADHD: Axsome is conducting the FOCUS study, a phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of ADHD in adults. The company anticipates topline results from the FOCUS study in the second half of 2024.
• Major depressive disorder: In March 2024, Axsome initiated the PARADIGM study, a phase 3, randomized, double-blind, placebo-controlled, multicenter trial of solriamfetol for the treatment of major depressive disorder. The company anticipates topline results from the PARADIGM study in 2025.
• Binge eating disorder: In March 2024, Axsome initiated the ENGAGE study, a phase 3, randomized, double-blind, placebo-controlled, multicenter trial of solriamfetol for the treatment of binge eating disorder. The company anticipates topline results from the ENGAGE study in 2025.

Anticipated milestones:

• Clinical trial topline results:
  • Phase 3 open-label safety extension trial of AXS-12 in narcolepsy (2H 2024)
• Clinical trial initiations and progress:
  • Phase 3 trial of solriamfetol in shift work disorder, initiation (2Q 2024)

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