Digital Therapeutics in Pediatric Behavioral Health — A unique opportunity to improve the standard of care and lifelong outcomes

 By Brent Vaughan, CEO and Co-Founder, Cognoa

 

We are experiencing a mental health crisis:one person in every four in the world will develop one or more behavioral conditions during their lifetime. Today in the U.S., one in five children have a diagnosable behavioral health disorder and only 21% of those children receive needed treatment. Mental and behavioral health conditions are chronic conditions. The impacts – if left untreated, misdiagnosed, or if access to appropriate treatment is delayed – span a lifetime, affect families and whole communities, and create greater economic and healthcare costs and burdens on society.

 

In mental and behavioral health, timing matters. This relates to the concept of neuroplasticity, which is, in general terms, the ability of the brain to change and rewire itself. One of the most heightened states of neuroplasticity is during our first years of life, when over a million new neural connections are formed every second. The brain circuits that are continuously used become “stronger”, while the connections that are less used are “pruned” away. These connections have come into focus as a target of disruption in disorders ranging from autism to schizophrenia.

 

While the advantages of early intervention are well researched, access to timely care is a persistent challenge. Parents who develop behavioral concerns and/or notice developmental delays do so at around 13 months of age, yet they often are forced to wait one to three years to receive the proper diagnosis and treatment for their child due to growing shortages of behavioral health specialists, leading to long wait times and the under-utilization of treatment. Today’s standard of care often misses the critical early intervention years, when treatments have the greatest opportunity to change lives and improve clinical and economic outcomes.

 

Over the last few years, we have indeed seen a spike in mental health innovations, with digital technologies being developed to give people greater access to care. But are we innovating to treat underlying states and causes of conditions, or are we largely stuck addressing symptoms?

 

Optimal treatments delivered during the key windows of synaptic plasticity can positively impact how the brain develops by reinforcing beneficial synaptic pathways to create lifelong improvements. This is why early childhood is the most critical developmental period in our lives. This is why pediatric behavioral health interventions are the greatest opportunity to impact and improve mental and behavioral health. And this is why Cognoa is a pediatric behavioral health company, focused on delivering scalable, accessible, earlier treatments.

 

Digital therapeutics and medicines are uniquely suited in pediatrics to become the first-line-of-care and primary interventions because of their superior safety profile versus pharmaceutical interventions. Machine learning-based digital therapeutics can enable physicians to come to faster, more accurate clinical decisions and continuously monitor improvements and responses to therapies, resulting in more personalized care. When these personalized interventions can be delivered over ubiquitous platforms, such as mobile phones, that work in conjunction with face-to-face, in-office treatments, they can overcome barriers to timely care, getting the right treatments to the right patients, at the right time.

Cognoa is first addressing autism first. Autism is a complex disorder with significant overlap with many other mental health disorders.

Autism is a behavioral condition where the unmet needs are quite clear. The average age of autism diagnosis has remained unchanged for over 15 years,  at 4 years, 4 months, missing the early intervention window (Cognoa’s machine learning algorithms have been clinically validated to identify autism in children as young as 18 months). Recent studies reinforce the current crisis in autism care. Last month, a study published in Pediatrics found that the most commonly used screener by pediatricians, the M-CHAT, was less effective in identifying autism than previously reported. Another study found that more than two-thirds of children flagged for autism were not referred to a specialist for treatment.

The value of early intervention in autism has been demonstrated in studies, showing that earlier diagnosis and treatment can enable up to 25% of high functioning autism patients to progress beyond their original diagnosis, and over 75% of children with autism to participate in mainstream education, as opposed to special education classrooms.

 

In order to reach every child and truly affect the standard of care, Cognoa believes the best approach is to empower parents and primary care physicians – those closest to the patient and to the child’s development. Pediatricians are the trusted family physicians who parents turn to first with developmental concerns and questions. We are developing digital therapeutics and medicines that will empower primary care physicians to confidently and accurately identify behavioral conditions and developmental delays early and prescribe treatments years sooner than today’s standard of care.

 

Underscoring the critical gap in care, Cognoa is the only digital therapeutics company with two FDA Breakthrough Device designations. Breakthrough designation provides priority review by the FDA and was awarded to Cognoa’s products because of their potential to provide more effective treatment or diagnosis for chronic conditions for which no approved alternative exists. Building upon our previous successful clinical studies, we recently announced the launch of a pivotal study of Cognoa’s autism digital diagnostic aid; the results of which we intend to submit as the basis of a premarket submission to the FDA in 2020. The Cognoa autism digital diagnostic has the potential to become the first cleared medical device to help diagnose autism. It is intended to enable pediatricians and physicians in primary care settings to make an autism diagnosis in children as young as 18 months, so that children can receive earlier treatment.

In tandem, Cognoa is developing a digital therapeutic for autism. Designed for mobile devices to be used at home with parents as an adjunct to standard behavioral therapy, the autism digital therapeutic targets a mechanism of action that addresses the underlying cause of the autistic behavior by reinforcing the appropriate pathways involved in facial and emotion recognition and improving social-emotional reciprocity in children with autism between the ages of 3 and 8 years. The therapeutic utilizes augmented reality and targets the core deficit of social-emotional reciprocity in ASD, with children showing gains in social initiation, facial engagement, emotion recognition, and social responses.

 

To support patient and physician access, Cognoa and its national pharmacy partner EVERSANA are working together to enable the routine prescription, dispensing and coverage by insurers and health plans of Cognoa’s digital therapeutics and medicines, so that these solutions can be available to every pediatrician and all children can benefit.

Cognoa is a pediatric behavioral health company, because we believe the most sustainable approach to reducing mental health conditions, associated illnesses, and costs to the healthcare system and communities is by enabling the systematic earlier identification of behavioral conditions so that children can receive earlier treatments when it matters most. Our two lead breakthrough products address the unmet needs in autism, and our pipeline also addresses additional, highly related pediatric behavioral health conditions including ADHD and anxiety.

If we want to make the most meaningful improvements and change the lives of families and children’s futures, we must innovate to create much more proactive approaches to behavioral healthcare, with a delivery system that is scalable and accessible to reach every child and family.

 

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