Click Therapeutics has nabbed FDA approval for its digital therapeutic Motivista, which now becomes the first authorized treatment for negative schizophrenia symptoms.
The therapy, formerly known as CT-155, has been handed 510(k) clearance from the FDA for the treatment of negative symptoms of schizophrenia. The go-ahead covers the therapeutic as an adjunct to clinician-managed antipsychotic therapy in patients 18-plus with clinically stable positive symptoms.
Negative symptoms of schizophrenia include social withdrawal, inability to feel pleasure and reduced emotional expression. Positive symptoms, meanwhile, include hallucinations and delusions.
Current antipsychotic medications have largely focused on the latter, leaving behind a large unmet need for precision psychiatry treatments that specifically target negative symptoms.
This makes Motivista the first FDA-authorized treatment indicated specifically for this group of schizophrenia patients in the U.S. and, the company believes, a strong contender in this underserved market.
The therapy works as a prescription digital therapeutic that is used on a smartphone via an app alongside standard care. It uses tailored goal setting, cognitive restructuring and social skills training to address a lack of drive and sociability.
Now comes the launch and marketing phase for the treatment, plans for which have changed in the past few months. Back in April, Click’s long-term partner for the therapy, Boehringer Ingelheim, restructured the marketing deal for what was then CT-155.
Under what the pair called a “strategic agreement,” announced in an April 9 statement, Boehringer handed over full product responsibility, including commercial and marketing authorization rights, to Click.
As part of the tactical shift, Boehringer also made a $50 million series D investment in the digital therapeutics company, as well as providing “dedicated commercial funding to help bring CT-155 to patients.” The same week, Click also announced it was cutting staff to focus on the commercialization of Motivista.
Speaking to Fierce just ahead of the approval, Richard DeNunzio, chief commercial officer at Click, said that after the Boehringer restructure, the company’s launch strategy “follows coverage.”
He said: “We expect to concentrate field presence, HCP education, provider support and advocacy engagement in states where patients can access Motivista. Because Medicaid covers a significant share of adults living with schizophrenia, state-level coverage decisions are pivotal.”
This will be a “targeted, state-by-state approach,” DeNunzio said, adding that as there is no approved pharmacotherapy for negative symptoms today, the company has seen “strong demand from both patients and providers," and it also anticipates "meaningful volume once coverage is established.”
David Benshoof Klein, founder and CEO of Click, added in an interview that his company will not be seeking another pharma company to help with commercialization. “Click will lead the launch and U.S. commercialization of Motivista,” he said.
“The scale and timing of the commercialization effort will follow coverage. As states establish access, we can deploy the appropriate field, education, provider-support, and distribution resources in those markets.”
No price tag has been added as yet.
“Because a large share of people living with schizophrenia rely on Medicaid, an out-of-pocket model would exclude many of the patients who need the treatment most,” DeNunzio explained.
“For patients with coverage, out-of-pocket cost sharing should look similar to what they expect for any covered prescription," he added. "That is why coverage matters so much.”
And the digital therapeutic's name? That blends motivation and vista. “The name was designed to feel as encouraging and inspirational as the product itself,” said Benshoof Klein. “It evokes a sense of internal drive, ‘motivation’, and a new outlook, ‘vista’, on what is possible."
Last year, Click received a groundbreaking green light from the FDA for the agency’s first prescription digital therapeutic aimed at preventing migraines.
Designed to be used alongside standard drug therapies, a randomized, sham-controlled trial of Click’s smartphone app showed it could significantly reduce an adult’s number of episodic migraine days per month.
Click also markets a depression therapy app developed with the drugmaker Otsuka and later acquired a diabetes-focused platform through its purchase of assets from the defunct digital treatment developer Better Therapeutics.
While Click has been showing positive results, other developers of prescription digital therapeutics, like Pear Therapeutics, have stumbled.
Pear filed for Chapter 11 bankruptcy in 2023 after experiencing trouble securing insurance reimbursements and revenue for its products that included FDA-cleared programs for opioid and substance use disorders, as well as insomnia.