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Axsome has Major Upcoming Catalysts, Find Out Here!

18 Jan Axsome has Major Upcoming Catalysts, Find Out Here!

Axsome Therapeutics, Inc. (NASDAQ: AXSM) uses its chiral chemistry and formulation capabilities to identify, isolate and stabilize chirally pure enantiomers for developing drug candidates for the treatment of central nervous system (CNS) disorders with large unmet needs. Its proprietary MoSEIC™ technology can increase the solubility and absorption of drug molecules, while its metabolic inhibition technology can increase the bioavailability and prolong the half-life. The company uses its in-depth knowledge of synthesis and analysis for narrowing target drug molecules.

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The Company has some major catalysts lined in 2021; we take a look at them below

AXS-05 – Major Depressive Disorder
Axsome Therapeutics is gearing up to submit its new drug application for AXS-05, a combination of bupropion and dextromethorphan for the treatment of major depressive disorder (MDD) in January 2021. The Company has reported positive results from an open-label Phase 2 COMET-SI trial with patients suffering from depressive disorder (MDD) who have suicidal ideation (SI). The candidate has demonstrated rapid reduction in of suicidal ideation, rapid functional improvement, and rapid, substantial, and durable improvements in overall depressive symptoms. 

AXS-05, a glutamate receptor modulator and a sigma-1 receptor agonist, has more than 93 issued U.S. and international patents providing protection until 2040, with the Company holding worldwide rights. It was awarded the Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of MDD in March 2019.

Herriot Tabuteau, MD, Chief Executive Officer of Axsome, opined

“The results of the COMET-SI trial suggest that AXS-05, as an oral NMDA receptor antagonist, may provide unique benefits to patients by potentially rapidly and durably improving not only suicidal thoughts but also functional impairment associated with depression. These positive effects expand on and are consistent with the differentiated clinical profile of AXS-05 observed in our completed controlled trials in patients with major depressive disorder.”

Major Depressive disorder is caused due to biological and psychological factors and can result in persistent depression, impairing sleep, behavior and quality of life. According to a report by GlobalData, the global major depressive disorder market is expected to reach $5.8 billion by 2025, growing at a CAGR of 6.1%, from $3.2 billion in 2015. Data from the 2017 National Survey on Drug Use and Health (NSDUH) suggests that nearly 11 million U.S. adults aged 18 or older had at least one major depressive episode with severe impairment. Bupropion is a popular treatment options for MDD, which will help the Company make inroads into the clinics without much resistance.

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AXS-07 – Migraine
AXS-07, a combination of AXS-07, MoSEIC™ meloxicam and rizatriptan is a rapidly absorbed, multi-mechanistic medicine with increased solubility, speed of absorption and durability of action. The candidate has demonstrated rapid onset of action, superior efficacy, sustained pain relief and pharmoeconomic benefits in clinical trials .The Company intends to file for an NDA in Q1, 2021 with the FDA, utilizing the 505(b) (2) regulatory development pathway.

Herriot Tabuteau, MD, Chief Executive Officer of Axsome, commented,

“The rapid and substantial efficacy of AXS-07 now observed in three separate trials indicates that AXS-07 may provide unique benefits to patients with migraine and help address the current unmet need for more effective treatments. These data further support our planned NDA filing of AXS-07 in the acute treatment of migraine in the first quarter.”

Migraine is a genetic predisposition to moderate-to-severe headaches caused due to stress, physiological factors such as lack of sleep, hunger and environmental triggers such as sensitivity to lights and sounds or hormonal changes in case of women. It manifests in the form of throbbing pain in the head, nausea, photophobia, excessive sweating etc. The International Classification of Headache Disorders system gives a differentiation between various kinds of migraines and headaches for easy diagnosis and treatment.

It is considered to be the third most prevalent disease in the world, affecting over 37 million in the U.S alone. It costs over $36 billion in lost productivity and incurs an estimated $5.4 billion in treatment costs. A report by Grand View Research predicts that the Global Migraine Therapeutics market will be worth over USD 7.8 billion by 2025 growing at a CAGR of 18.0%.

The current treatment options for migraine consist of generic triptans and other off-label drugs that have adverse side effects and are by and large ineffective. These come with side-effects such as drowsiness, memory related issues and weight gain.

AXS-05 – Alzheimer
AXS-05, a combination of bupropion and dextromethorphan, is its lead candidate for treatment of agitation associated with Alzheimer’s. The drug combines Dextromethorphan which is an NMDA receptor antagonist, sigma-1 receptor agonist, and inhibitor of the serotonin and norepinephrine transporters along with Bupropion that increases the bioavailability of dextromethorphan, and is a norepinephrine and dopamine reuptake inhibitor, and a nicotinic acetylcholine receptor antagonist.  In August 2020, the Company had a Breakthrough Therapy meeting with the FDA, which led to the initiation of ACCORD (Assessing Clinical Outcomes in Alzheimer’s Disease Agitation), a Phase 3  trial to evaluate the efficacy and safety of AXS-05 in the treatment of Alzheimer’s disease (AD) agitation. Topline results from the trail are expected to be announced in H2, 2022.

Alzheimer’s is the sixth leading cause of death in the U.S, a disease that causes irreversible degeneration of the brain cells and affects a person’s cognitive and behavioral abilities such as impaired judgment, deteriorating memory and personality changes with the gradual loss of motor abilities and speech.

According to some compelling statistics made available by Alzheimer’s Association over 5.8 million Americans are affected by this disorder and the numbers will most likely reach 14 million by 2050, with a new diagnosis being made every 65 seconds. The healthcare cost of Alzheimer’s and other Dementia related ailments will be over $290 billion in 2019, these numbers are likely to escalate further to over $1.1 trillion by 2050.

report by transparency market research predicts that the global market for Alzheimer’s will reach US$6.4 billion by 2025, growing at a CAGR of 7.5%, from US$3.6 billion in 2017. The rise in ageing population, increased awareness about the benefits of combined therapy, a favorable regulatory and government support environment are some of the factors that will contribute to the growth of the market.

Axsome Therapeutics (NASDAQ: AXSM)

Market Cap: $2.87B; Current Share Price: 76.75 USDChart
Data by YCharts

Key Takeaways

  • The Company has two major catalysts in 2021, filing of NDA for AXS-05 in MDD and another in migraine (AXS-07), expected to be filed in Q1, 2021. Launching a new drug is not easy however the candidates are using drug combinations that are popularly used and have combined it with their unique technology to deliver superior efficacy.
  • Axsome intends to initiate a phase 3 trial in narcolepsy for its lead candidate AXS-12(reboxetine), a highly selective and potent norepinephrine reuptake inhibitor. Reboxetine has a proven safety record in Europe as well as 40 countries worldwide, where it is currently approved for depression. The clinical results from preclinical and preliminary studies point to the efficacy of AZS-12, by significantly reducing narcoleptic episodes in hypocretin (orexin)-deficient mice. In addition, patients in a pilot trial experienced improving daytime sleepiness with reduced cataplexy.
  • The Company will be meeting with the FDA in the first quarter of 2021 to discuss its plan for AXS-14 in fibromyalgia.
  • Launch readiness activities are in full swing, with the development of Digital-Centric Commercialization (DCC™) platform that intends to leverage real-time data, sophisticated analysis and seamless integration to provide optimized customer engagement.
  • As per its Q3, 2020 financial results, the Company had $202.4 million in cash and cash equivalents and a loan facility of $225M, which would help fund its trials and other operational expenses until 2024.
  • Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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