Clinical stage biopharmaceutical company Axsome Therapeutics (AXSM) announces positive outcome for ADVANCE-1 trial associated with the treatment of Alzheimer’s disease. Shares of Axsome Therapeutics jumped about 180% in the pre-market trading on Monday.
An independent data monitoring committee (IDMC) analyzed and recommended the continuation of AXS-05, an investigational drug to treat central nervous system disorders, in the ADVANCE-1 trial. Axsome’s AXS-05 drug has got FDA’s Fast Track designation for the treatment of Alzheimer’s disease agitation.
“The positive recommendation by the IDMC to continue the ADVANCE-1 trial is an important milestone for the Alzheimer’s disease agitation program and we look forward to the continued development of AXS-05 for this indication,” said CEO Herriot Tabuteau.
In the last week of December, Axsome provided a clinical update for the year 2018. The company anticipates to start Phase 3 trial of its migraine treatment drug AXS-07 in the current quarter. The New York-based firm also anticipates initiating Phase 2 trial of AXS-12 study for the treatment of narcolepsy in January 2019, with topline results in the first half of 2019.
According to Alzheimer’s Association, Alzheimer’s disease is the sixth leading cause of death in the US and one in three seniors dies with Alzheimer’s or another dementia. It is estimated that 5.7 million Americans are living with Alzheimer’s and this figure is projected to increase to nearly 14 million by 2050.
Axsome stock, which closed down 0.75% at $2.63 on Friday, achieved a new 52-week high in the morning trading session. The stock had dropped 28% in the last three months and 53% in the last 12 months.