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Alzheimer's Disease Drug Trial Concludes Early Due to COVID-19 Concerns

By Cory Renauer - Mar 20, 2020 at 2:29PM

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Axsome Therapeutics is wrapping up a late-stage clinical trial early to ensure patient safety during the coronavirus pandemic.

The pharmaceutical industry has been moving fast to respond to the coronavirus pandemic -- but not all companies have been adjusting in the same ways.

For Axsome Therapeutics (AXSM 6.11%), adapting to COVID-19 has meant concluding patient participation early in the late-stage study of its lead drug candidate, AXS-05, in patients with Alzheimer's disease agitation. The changes to the study's protocols were made in compliance with new guidance from the Food and Drug Administration. 

But beyond the fact that it sped up the study, it also said the trial's top-line results, which had been expected in the third quarter, will be ready early in the second quarter.  

Healthcare provider holding up a gloved hand.

Image source: Getty Images.

Right now, people 65 and older should be self-isolating at home, which makes it hard for them to participate in clinical trials. Luckily, this was a short five-week study to see if patients taking AXS-05, a combination of bupropion and dextromethorphan, would outperform patients given a placebo on the Cohen-Mansfield Agitation Inventory (CMAI) test.

At the time of its announcement, Axsome had already completed randomizing hundreds of patients into groups, and more than 90% of patients enrolled had completed five weeks of treatment and observation.

A sign of confidence

Axsome didn't have to tell investors that it was nearly finished with the study, and it could have delayed publishing its data for months. The decision to unblind the data earlier is a strong sign the company feels good about AXS-05.

At the moment, Alzheimer's disease affects about 5 million Americans, and roughly 45% of them report states of agitation. While this is a large potential patient population, it's not the only sizeable group that Axsome hopes will be helped by AXS-05. A different study of the drug in treatment-resistant depression is expected to produce pivotal results by the end of March.

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