Summary: Axsome Therapeutics’ Q1 2024 report highlights advancements in its slumber drugs pipeline, with good phase 3 outcomes for AXS-12 in narcolepsy therapy and earnings progress for Sunosi, reflecting solid economic performance and development in addressing sleep disorders. In addition, the business showcases promising developments in its neuroscience portfolio, which include ongoing medical trials for solriamfetol in ADHD, big depressive ailment, binge consuming condition, and shift get the job done dysfunction.
Essential Takeaways:
- Axsome Therapeutics claimed strong fiscal effects for Q1 2024, with full web merchandise revenue reaching $75 million, marking 160% 12 months-about-calendar year development. Sunosi, a critical product in Axsome’s industrial portfolio, contributed to this expansion with a revenue boost of 64% compared to the former yr.
- The business showcased progress in its rest medication pipeline, particularly with the announcement of favourable period 3 effects for AXS-12 in narcolepsy cure.
- Axsome is actively advancing its neuroscience portfolio, with the ongoing enhancement of solriamfetol for numerous disorders, which includes shift perform ailment.
Axsome Therapeutics declared its initial quarter 2024 company highlights and money outcomes, showcasing developments in its rest medicine portfolio, which includes optimistic period 3 success for AXS-12 in narcolepsy treatment and profits expansion for Sunosi.
Sunosi is approved to handle wakefulness for abnormal daytime sleepiness thanks to obstructive sleep apnea or narcolepsy.
“The initial quarter was marked by robust monetary overall performance for our on-current market items which are providing significant and differentiated cure alternatives for people living with melancholy, narcolepsy, and obstructive snooze apnea,” suggests Herriot Tabuteau, MD, CEO of Axsome Therapeutics, in a launch. “We also considerably state-of-the-art our modern neuroscience pipeline in the quarter. We introduced constructive stage 3 outcomes for AXS-12 in narcolepsy, a big stage towards making this new drugs out there to sufferers residing with this debilitating situation.”
Initially quarter 2024 economical highlights:
- Complete net solution income for the 1st quarter of 2024 was $75 million, symbolizing 160% year-more than-yr progress. Complete internet item earnings for the comparable period of time in 2023 was $28.8 million. All round complete revenue for the 1st quarter of 2023 was $94.6 million which included a a single-time $65.7 million upfront payment gained for the out-licensing of Sunosi commercialization legal rights in Europe and specific countries in the Center East and North Africa area.
- Sunosi internet item earnings was $21.6 million for the to start with quarter of 2024, consisting of $20.7 million in web product or service sales and $.9 million in royalty income associated with gross sales in out-certified territories, symbolizing 64% yr-above-12 months development. Sunosi web product income for the equivalent period of time in 2023 was $13.2 million, consisting of $12.9 million in net products income and $.3 million in royalty earnings.
Commercial highlights for Sunosi:
- Close to 42,000 prescriptions were being published for Sunosi in the US in the to start with quarter of 2024, representing a 1.6% lessen versus the fourth quarter of 2023.
- Sunosi maintains broad payer protection in the professional channel with 95% of life coated. Presently 83% of full life across all channels are coated.
Axsome’s Sleep Medication Advancement Pipeline
Axsome is advancing its neuroscience portfolio encompassing five late-phase, patent-guarded solution candidates for 10 psychiatric and neurologic problems, which have an affect on much more than 150 million men and women in the US by itself. Current and predicted development for important pipeline programs in snooze drugs is summarized underneath.
AXS-12
AXS-12 (reboxetine) is Axsome’s novel, oral, potent, investigational really selective norepinephrine reuptake inhibitor and cortical dopamine modulator for the therapy of narcolepsy. AXS-12 has been granted US Foods and Drug Administration Orphan Drug designation for the procedure of narcolepsy.
- Narcolepsy: In March 2024, Axsome announced beneficial topline success from the SYMPHONY trial, a stage 3, randomized, double-blind, multicenter, placebo-managed demo of AXS-12 in sufferers with narcolepsy. AXS-12 accomplished the most important endpoint by appreciably reducing the frequency of cataplexy attacks as in comparison to placebo in clients with narcolepsy. AXS-12 also diminished too much daytime sleepiness severity, improved cognitive function, lessened overall narcolepsy severity, and enhanced affected individual purpose and quality of everyday living, as when compared to placebo. AXS-12 was perfectly tolerated in the demo.
- A stage 3 open up-label protection extension demo of AXS-12 is at this time ongoing with completion expected in the fourth quarter of 2024.
- In March 2024, the organization also announced topline results from the CRESCENDO (Characterizing Client Views on Unmet Demands in Narcolepsy) study of 203 narcolepsy individuals with cataplexy (narcolepsy type 1) who are currently acquiring treatment method. The outcomes demonstrated superior rates of persistent symptoms with 77%, 64%, and 74% continuing to expertise cataplexy, abnormal daytime sleepiness, and cognitive impairment, respectively, regardless of becoming on existing treatments. CRESCENDO was carried out by a 3rd-celebration investigation agency that labored with Narcolepsy Network to assure individual privacy. Narcolepsy Community is a nationwide non-earnings affected individual assistance group for individuals with narcolepsy, idiopathic hypersomnia and similar rest issues.
Solriamfetol
Solriamfetol is Axsome’s dopamine and norepinephrine reuptake inhibitor and TAAR1 agonist in progress for the remedy of focus deficit hyperactivity dysfunction (ADHD), major depressive ailment, binge taking in dysfunction, and extreme sleepiness associated with shift work disorder.
- Shift do the job condition: The company is on track to initiate a period 3 trial of solriamfetol for the cure of abnormal sleepiness linked with change work problem in the 2nd quarter of 2024.
- ADHD: Axsome is conducting the Focus examine, a period 3, randomized, double-blind, placebo-managed, multicenter trial to evaluate the efficacy and safety of solriamfetol for the treatment method of ADHD in grownups. The company anticipates topline success from the Target analyze in the second 50 % of 2024.
- Significant depressive ailment: In March 2024, Axsome initiated the PARADIGM research, a phase 3, randomized, double-blind, placebo-managed, multicenter trial of solriamfetol for the procedure of significant depressive dysfunction. The company anticipates topline results from the PARADIGM review in 2025.
- Binge taking in condition: In March 2024, Axsome initiated the Interact study, a stage 3, randomized, double-blind, placebo-managed, multicenter demo of solriamfetol for the cure of binge having problem. The corporation anticipates topline outcomes from the Engage research in 2025.
Expected milestones:
- Clinical trial topline effects:
- Phase 3 open-label security extension demo of AXS-12 in narcolepsy (2H 2024)
- Medical demo initiations and progress:
- Section 3 trial of solriamfetol in change operate disorder, initiation (2Q 2024)
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