A Boston-based startup is looking to help treat neurodegenerative disease with a smartphone-based digital therapeutic called Neuroglee.

This morning the startup got a boost when it closed a $10 million Series A round led by Openspace Ventures with participation from EDBI, Eisai Co and individual investors. 

“Various techniques have been demonstrated to slow or improve cognitive impairment in Alzheimer’s disease,” Aniket Singh Rajput, CEO of Neuroglee, told MobiHealthNews in an email.

“While the majority of this work has been demonstrated in the hospital setting in inpatient programs, we had a dream of bringing that type of therapy to patients in their own homes – especially to those patients who aren’t near a clinical center of excellence with this type of program.

"We will now be able to do that by working with patients’ clinicians across the country via our virtual care and digital therapy solutions.”

WHAT IT DOES 

Neuroglee Therapeutics is currently focusing on patients with mild cognitive impairments, such as early stage Alzheimer's. Its technology includes three main components: an app for patients, an app for caregivers and a web-based portal for clinicians. 

The patient app includes a slew of interventions, including reminiscence therapy, which uses images from a patient’s past to evoke emotions and memories, cognitive games, learning modules, and wellness modules that include mind and body exercises. 

“The digital patient tool employs engaging gamification techniques and cognitive tasks on a smartphone or tablet so that patients’ clinicians can remotely monitor their cognitive function and intervene using personalized cognitive rehabilitation techniques,” Rajput said in an email.

“Neuroglee’s machine-learning algorithms personalize each patient's therapy by automatically adjusting, or titrating, the therapeutic mobile-based activities based on several novel digital biomarkers tied to cognitive function, mood and behavior.”

Caregivers are able to access an app that allows them to monitor the patient’s care and track adherence, as well as communicate with the patient virtually. 

“An important aspect of Neuroglee’s platform is that it is not just for patients and professional clinicians, but also for patients’ families, who are most often the caregivers in the home,” Rajput said. “A concerning statistic is that 76% of the caregivers for people with Alzheimer’s disease report that their own health has worsened as they have cared for a family member.

"That is why Neuroglee has a separate caregiver module that helps them manage their family member with a neurodegenerative condition, but also offers education, support and tools for identifying and overcoming the stress, anxiety and other symptoms that can affect caregivers.”

Similarly, doctors and nurses will be able to access a dashboard that monitors a patient’s progress. The dashboard lets clinicians track a patient’s cognition over time. 

Currently Neuroglee is an investigational product in a proof of concept study. The startup plans to seek an FDA Breakthrough designation after the study is completed. 

The startup is teaming up with the Mayo Clinic to co-develop Neuroglee Connect, a clinical care program that will incorporate the Mayo Clinic’s Healthy Action to Benefit Independence & Thinking (HABIT) and Neuroglee’s “adaptive learning platform.” As part of the collaboration, patients will be able to tap into 24/7 health navigators and clinical care teams for assessments and interventions. 

WHAT IT’S FOR 

The company plans to use the new infusion of cash towards building its digital therapeutic. 

“​​The funding will primarily help us further develop our first line of virtual care solutions and digital therapeutics for treating mild cognitive impairment related to difficult-to-treat neurodegenerative conditions such as Alzheimer’s disease, while also advancing additional digital therapeutics in our pipeline.

"At the same time, the funding will help us complete the necessary research, verifications and documentation for earning a Breakthrough Device designation from the FDA for our digital therapeutic solution," Rajput said in an email. 

The company also plans to use the new cash to develop Neuroglee Connect and move its operations from Singapore to Boston. 

MARKET SNAPSHOT

This isn’t the first digital therapeutic to look at neurodegenerative conditions. In 2018, San Diego-based Dthera Sciences landed an FDA Breakthrough Device designation. However, by 2021, the company had dissolved. 

The company's CEO Ed Cox said that limited CMS reimbursement and numerous candidate-drug failures among potential partners severed Dthera’s commercialization plan. 

However, there are several digital therapeutics that have made it to the market. In 2017, Pear Therapeutics’ ReSET landed an FDA de novo to treat substance use disorder. Since then, Pear landed a number of other FDA clearances. Recently it went public through a $1.6 billion SPAC merger with Thimble Point Acquisition.