Annovis Bio Files for FDA Orphan Drug Designation for ANVS401 for the Treatment of Alzheimer’s Disease in Persons with Down Syndrome

Annovis Bio Inc. (NYSE American: ANVS), a clinical-stage drug platform company addressing Alzheimer’s disease (AD), Parkinson’s disease (PD) and other neurodegenerative diseases, today announced it has filed an application with the U.S. Food and Drug Administration (FDA) to receive orphan drug designation for its lead drug candidate, ANVS401, for the treatment of AD in persons with Down syndrome (DS), referred to as DS-AD.

DS occurs in about 1 in 700 newborns and approximately 200,000 people in the U.S. have the condition. People with DS often experience a gradual decline in cognition as they age, which can lead to AD. Newer screening methods and publications estimate DS-AD begins in people in their late thirties, with measurable decline starting before 40 years of age. Remarkably, over 80% of those with DS over age 65 are demented due to AD. There are approximately 17,000 people living with DS-AD in the United States, making the condition an orphan indication.

With improved healthcare, the DS population is both growing and aging. However, with improved longevity comes a very high risk of AD. The percentage of DS patients with AD is growing faster than the percentage of AD patients in general. The condition results in significant suffering and financial burden for those who care for people with DS.

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