Otsuka, Click Therapeutics get FDA clearance for prescription digital therapeutic

Otsuka Pharmaceuticals and Click Therapeutics announced that Rejoyn, a smartphone-based prescription digital therapeutic for major depressive disorder (MDD), scored FDA clearance to be used as an adjunct to clinician-managed care. 

Rejoyn is a six-week remote treatment program to help enhance cognitive control of emotion through a combination of clinically-validated cognitive emotional training and brief therapeutic exercises. 

The prescription digital therapeutic is expected to be released in the second half of 2024 and available for patients 22 years and older who are taking an antidepressant medication. 

“Rejoyn has a neuromodulatory mechanism designed to act like physical therapy for the brain by delivering personalized, consistent brain-training exercises designed to help improve connections in the brain regions affected by depression,” Dr. Brian Iacoviello, assistant professor in the department of psychiatry at Icahn School of Medicine at Mount Sinai and scientific advisor at Click Therapeutics, said in a statement. 

“When stronger and more balanced connections are created, the regions of the brain responsible for processing and regulating emotions are better able to work together and symptoms of depression can improve.“

THE LARGER TREND

Otsuka and Click first partnered in 2021 for a clinical trial, which resulted in the Rejoyn app. Named the Mirai study, the goal was to measure digital therapeutics intervention effectiveness in adults with MDD. 

The same year, the Japan-based company collaborated with data science and digital health firm Holmusk for a three year collaboration. The partnership employed data analytics and AI on real-world data to drive a deeper understanding of unmet patient needs and real-world outcomes. 

A year later, Click Therapeutics partnered with Boehringer Ingelheim to co-develop and commercialize digital therapeutics for adult patients with schizophrenia. The deal garnered Click approximately $460 million in funds, and, in January, the FDA granted the pair breakthrough designation for a smartphone app CT-155. 

In 2021, Click raised $52 million in Series B funding, and the next year, secured a $15 million loan from Silicon Valley Bank, a year before the bank imploded making it the third largest bank failure in U.S. history. 

Click closed a $20 million loan from HSBC Innovation Banking last year, with the proceeds used to retire the company’s previous term loan. The company said it would use the remaining balance to advance its prescription pipeline. 

Click Therapeutics was one of four bidders to win the assets of prescription digital therapeutics company Pear Therapeutics, which filed for bankruptcy last year. During an auction for the PDTx company’s assets last year, Click obtained all Pear’s platform patents, excluding those related to the ISF assets, for $70,000.