Axsome Therapeutics ( AXSM Quick Quote AXSM - Free Report) announced that the first patient has been enrolled in the ADVANCE-2 phase III study evaluating its lead candidate, AXS-05, for treating Alzheimer’s disease (AD) agitation.
AXS-05 is an oral investigational N-methyl-D-aspartate (NMDA) receptor antagonist with multimodal activity. The company is developing the candidate for various central nervous system (CNS) disorders.
Alzheimer’s disease is the most common form of dementia. It is a progressive neurodegenerative disorder causing cognitive decline and other behavioral and psychological symptoms, including agitation. Agitation as a symptom is reported by approximately 70% of AD patients. Presently, there is no FDA-approved treatments for AD agitation.
ADVANCE-2 phase III study is a randomized, double-blinded, placebo-controlled study conducted on approximately 350 patients for five weeks to determine the safety and efficacy of AXS-05 in AD agitation. The primary efficacy measure is the Cohen-Mansfield Agitation Inventory (CMAI).
The target market represents a massive opportunity. If the study progresses well, a potential label expansion of AXS-05 will majorly boost Axsome’s portfolio.
Shares of Axsome have returned 62% in the year-to-date period against the
industry’s decline of 21.7% Image Source: Zacks Investment Research
AXS-05, marketed by the trade name Auvelity, was approved by the FDA for the treatment of Major depressive disorder (MDD) in August, making it the first approved drug in Axsome’s portfolio. AXSM intends to launch Auvelity in the United States in the fourth quarter of 2022, post which the company is likely to generate revenues from the sale of the drug.
Axsome is also developing AXS-05 to aid smoking cessation treatment, and a phase II study on the same indication has been completed.
Axsome also has a late-stage pipeline candidate AXS-07 in its portfolio being developed for CNS disorders. Only last week, the company enrolled its first patient in the EMERGE phase III study evaluating AXS-07 as a potential treatment for acute migraine to bring more clarity to the candidate’s clinical profile.
AXS-07 is also on the verge of a FDA approval. Its new drug application (NDA) of AXS-07 for the acute treatment of migraine received a complete response letter (CRL) from the FDA on chemistry, manufacturing, and controls (CMC) grounds. But the company intends to refile its NDA post a CMC clean-up guided by an FDA consultation.
Other pipeline candidates of Axsome include AXS-12 and AXS-14, which are being evaluated for multiple CNS disorders.
Zacks Rank and Stocks to Consider
Currently, Axsome has a Zacks Rank #3 (Hold).
Some better stocks in the same sector are
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