CT-152 (Rejoyn?) is FDA Cleared

Today is a monumental day for Click, and I could not be more thrilled to share this news with you. Rejoyn?, originally developed as CT-152, is now THE FIRST prescription digital therapeutic to receive FDA clearance for the treatment of Major Depressive Disorder (MDD) symptoms. Rejoyn? is indicated as a prescription digital therapeutic for the treatment of Major Depressive Disorder (MDD) symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD age 22 years and older who are on antidepressant medication. It is intended to reduce MDD symptoms. As first in its device type, Rejoyn? was also assigned a new product code by FDA: “SAP - computerized behavioral therapy to treat major depressive disorder.”

This FDA clearance represents an example of how digital therapeutics are positioned to help define the future of clinical care. The MIRAI study validated Rejoyn’s? novel treatment approach and was central to the FDA filing. It is one of the largest studies completed to date on a digital therapeutic and one of the very few to evaluate a digital therapeutic’s effectiveness in a blinded comparison to a sham app that was designed to match the treatment in time, attention, and participant expectation of therapeutic effect.

The robust randomized controlled trial provided consistent evidence of effectiveness from both clinician and patient perspectives giving confidence in the benefit of Rejoyn? as an adjunctive option for the treatment of MDD symptoms. The effectiveness was supported by a demonstrated safety profile with no treatment-emergent adverse events assessed as related to Rejoyn? in the trial. Together the clinical trial data demonstrate that Rejoyn? offers a novel adjunctive therapeutic option to treat MDD symptoms for adult patients who are experiencing an inadequate response to their antidepressant medication. And importantly, the Rejoyn? data show that a prescription digital therapeutic can demonstrate a benefit beyond what patients were able to achieve with their existing antidepressant medication.

Quite simply, Rejoyn? has the potential to help shift the course of mental health treatment by being the first to introduce the concept of a prescription digital therapeutic for the adjunctive treatment of MDD symptoms into the clinical mainstream at scale. We believe this product could mark a turning point toward a future in which clinically validated prescription software is a routine part of the standard of care.

I’m incredibly proud of the teams at Click, Otsuka and Mount Sinai who worked together to achieve today’s news, which is the culmination of years of effort. Congratulations to all involved!??

This news comes at a very exciting time for our industry given the FDA Draft Guidance released last September on Prescription Drug Use-Related Software (PDURS) formally clarified that any added clinically meaningful benefit from the use of software together with a drug can be added directly to the drug label, right in the package insert. Soon, combination products developed using PDURS will unlock drug-like reimbursement via existing access pathways and extend the benefits of digital therapies to any therapeutic area with unmet behavioral, neurological, or cognitive needs where the drug alone may not be enough.

The future ahead is an exciting one, that if approached right, will enable a vibrant and evolving ecosystem of digital treatment options for patients. We are passionate about this vision and could not be more excited to make this future a reality. We are grateful for our collaborators, dedicated investors, and many exceedingly talented colleagues who have made today’s news possible. And if you haven’t already, we invite you to please join us – the opportunity to improve patient care with digital therapeutics is just beginning.?

You can read more about the clinical data for Rejoyn? in the Clinician Brief Summary; a link is provided below.

https://rejoynhcp.com/Clinician-Brief-Summary.pdf

You can read more about the FDA Clearance in the press release; a link is provided below.

https://www.otsuka-us.com/news/rejoyn-fda-authorized

With warm regards,?

David Benshoof Klein

CEO, Click Therapeutics

INDICATION and SAFETY INFORMATION for Rejoyn?

INDICATION:?

Rejoyn? is a prescription digital therapeutic for the treatment of Major Depressive Disorder (MDD) symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD age 22 years and older who are on antidepressant medication. It is intended to reduce MDD symptoms.

SAFETY INFORMATION:?

Rejoyn? is not intended to be used as a standalone therapy or a substitute for medication. Patients should continue their current treatment as directed. Rejoyn? does not monitor the patient’s symptoms or clinical status and cannot send or receive alerts or warnings to the prescriber.?

Patients should be clearly instructed that if they believe their depression is worsening or if they have feelings or thoughts of harming themselves or others, to contact a healthcare professional, dial 911, or go to the nearest emergency room immediately.