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Dthera Sciences Gets Regulatory Win in Alzheimer’s, But Not For a Drug

Dthera Sciences Gets Regulatory Win in Alzheimer’s, But Not For a Drug

The company recently announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation to their non-pharmacological Alzheimer’s treatment, DTHR-ALZ.

While major pharmaceutical companies are exiting the challenging Alzheimer’s disease drug development race, San Diego-based digital therapeutics company Dthera is making headway. The company recently announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation to their non-pharmacological Alzheimer’s treatment, DTHR-ALZ.

According to Dthera, they are only the second digital therapeutics company in history to be granted breakthrough status for a device by the regulator. While the company’s prescription DTHR-ALZ product isn’t designed to directly treat Alzheimer’s disease, it could help mitigate symptoms of depression and agitation associated with the neurodegenerative disease.

“Alzheimer’s disease is a significant and rapidly growing public health crisis, and, among the 10 leading causes of death in the US, it is the only one that cannot be prevented, cured or slowed,” said Edward Cox, CEO of Dthera Sciences. “We commend the FDA for recognizing this significant unmet medical need as well as the critical importance of providing innovative new treatments to patients with Alzheimer’s and their caregivers. While we feel this ground-breaking recognition validates Dthera’s mission to positively impact the lives of those effected by the disease, it also represents a meaningful advance for the entire digital therapeutic sector.”

DTHR-ALZ delivers reminiscence therapy to patients with Alzheimer’s using an artificial intelligence system to tailor the therapy based on biofeedback collected from the patient. Reminiscence therapy uses all five senses to help patients with Alzheimer’s discuss memories and past experiences, and is recognized by the Alzheimer’s Association as a potentially effective, evidence-based intervention for the disease.

Despite the fact that reminiscence therapy has shown some promise in clinical trials, it is not widely offered to patients with dementia due to its demands on caregiver time and resources. If approved, DTHR-ALZ has the potential to reduce the time investment required for reminiscence therapy to allow more patients to have more frequent access to this psychosocial intervention.

“This Breakthrough designation has provided us with a remarkable opportunity to expedite the development of our digital therapeutic device,” said Dr. Martin Culjat, VP of Scientific and Regulatory Affairs at Dthera Sciences. “We feel deeply honored that the FDA has confirmed DTHR-ALZ meets the requirements for this designation, and we are eager to work together with the FDA throughout this process.”

It’s estimated that 5.7 million individuals in the US have Alzheimer’s disease, with care costs totalling $277 billion in 2018. As the population ages, this number could jump to over $1 trillion by 2050 if no new therapeutic options become available in the next 30 years.