Click Therapeutics, Inc.

We are proud to share that npj Digital Medicine (Nature Portfolio) has published our manuscript, "Integrated Analysis of Two Randomized Controlled Trials of a Digital Therapeutic for Episodic Migraine Prevention.” The burden of migraine makes effective preventive care a top priority. CT-132 is an FDA-authorized prescription digital therapeutic (PDT) for the preventive treatment of episodic migraine. The integrated post-hoc analysis of two Phase III trials (ReMMi-D and ReMMiD-C, N=678) demonstrates that this adjunctive treatment significantly reduces monthly migraine days (MMDs). Data also show improvements in migraine disability and migraine-related quality of life measures. Key Results: • Effectiveness: Significant reduction in monthly migraine days (p=0.003). • Flexibility: Clinical benefits were observed for patients using a variety of medications for migraine, including those taking CGRP inhibitors. • Safety: No device-related adverse events reported. Thank you to our authors, Shaheen E Lakhan, MD, PhD, FAAN, Mariya Petrova, LMHC, PhD, Cassandra Snipes, Alex Kuka, PhD, Tim Peters-Strickland, Olya Besedina, Laura Taraboanta, Viveca Livezey, MD, FAAN Austin Speier, Merle Diamond, Stewart Tepper and all who contributed to this incredible milestone. Read the full publication here: https://lnkd.in/eMP4E6z6 Important Safety Information Indications for Use: CT-132 is a prescription digital therapeutic indicated for the preventive treatment of episodic migraine in patients 18 years of age and older. It is intended for adjunctive use alongside acute and/or other preventive treatments.

Click Founder and CEO, David Benshoof Klein, will be speaking at the US Pharma and Biotech Summit, presented by FT Live in collaboration with Endpoints News on May 14th! David will share how Click is introducing Over-the-Counter Digital Therapeutics (ODTx), a category designed to bridge the gap between consumer wellness and medical-grade software. By transforming passive biometric data into actionable treatment, ODTx serves as the industry’s "missing link." The session will further examine the ways consumer health technology is reshaping healthcare delivery and access, and explore the path forward for wearables and apps to provide meaningful intervention and system value. Check out the full event agenda here: https://lnkd.in/e6Z6fHMM #DigitalTherapeutics #ClickTherapeutics #FTPharma

PDURS is Pharma’s Most Valuable Asset for "Beyond the Pill" Success 📱🚀 In a new collaborative piece for IQVIA, Steven Lee and Nick Mageras dive into why Prescription Drug Use-Related Software (PDURS) is the ultimate game-changer for the life sciences industry and how digital innovations can be used to supplement how outcomes are delivered to power successful pharmaceutical brands. PDURS unlocks a significant opportunity for innovation in therapy delivery. It bridges the gap between digital innovation and commercial impact to capture immense value for the entire healthcare ecosystem. Despite increasing innovation, drug development in the U.S. has remained consistently limited to around 50 drug approvals a year. This pace has not kept up to offset the massive $300 billion revenue loss projected by 2030 as 8,000 global patents expire. Additionally, payers are increasingly demanding greater clinical and economic value from the drugs they already fund. Software-driven clinical benefits can now be integrated directly into a drug’s FDA-authorized package insert. This Software-Enhanced Drug™ approach allows Pharma to: • Elevate Patient Care: Treat the whole patient by delivering clinical outcomes that address challenges exacerbated by health behaviors, mental health or treatment side effects. • Differentiate on Efficacy: Claim new or improved clinical outcomes that pharmacotherapy alone cannot achieve. • Defend Market Share: Use SaMD-based IP to protect franchises beyond LOE (Loss of Exclusivity). Click Therapeutics, Inc. has been paving the way to deliver software-as-a-medical-device with the development rigor needed to meet the regulatory and clinical requirements of the pharmaceutical industry. The development of our digital therapeutics for adjunctive use to standard of care pharmacotherapy already mirrors the evidentiary bar PDURS is designed to meet. Give your medicine the digital upgrade it deserves. Because at Click, we know that 1 + 1 = 3. Read the full insights here: https://lnkd.in/efKFWH6y #DigitalTherapeutics #PharmaInnovation #PDURS #SoftwareEnhancedDrugs #HealthTech #ClickTherapeutics #IQVIA

Fierce was one of my favorite conferences from last year. The subject matter diversity and intimacy of the event fostered real, refreshing conversations with fellow innovators. I’ll be back at Fierce Biotech next week. If you’re going to be there and want to chat about the intersection of tech and biotech, let’s connect! Fierce Life Sciences Events

📱⚕️From Insight to Intervention: Why Over-the-Counter Digital Therapeutics (ODTx) are the Next Step for LLMs and Wearables Wearables and LLMs are increasingly improving our grasp of the "what" of health data. But without a clinical "how" to action it, that data remains an untapped resource. In their latest op-ed for MedCity News, Austin Speier and Steven Lee put a stake in the ground: The industry’s next leap isn't more tracking or analytics - it's intervention. Over-the-Counter Digital Therapeutics (ODTx) are the key to closing this gap. By combining consumer-grade accessibility with biotech-level rigor, ODTx converts raw insights into evidence-based software treatments. At Click Therapeutics, Inc., we aren't just watching the data; we’re redefining medicine by turning it into action. The future of digital medicine is here. Read why ODTx is the next step for the wearable landscape: https://lnkd.in/dYJU3SPG #digitaltherapeutics #digitalhealth #wearables #healthai

Thank you Nasdaq, for highlighting and celebrating our latest milestone in Times Square! Last week, Click Therapeutics, Inc. and Boehringer Ingelheim announced a $50M Series D investment and a new strategic agreement to advance the commercialization of CT-155. As an investigational prescription digital therapeutic, CT-155 is designed to treat negative symptoms of schizophrenia in adults. This is a pivotal step forward in our mission to redefine the standard of care through clinically validated digital medicine. We are proud to continue bringing safe, impactful, and transformative treatments to patients in need. #DigitalTherapeutics #PrescriptionDigitalTherapeutics

Today, Click Therapeutics, Inc. and Boehringer Ingelheim announced a Series D investment and strategic agreement to advance the commercialization of CT-155, an investigational prescription digital therapeutic for the treatment of the negative symptoms of schizophrenia in adults aged 18 years and older. Under the agreement, Boehringer will transfer full product responsibility, including all commercial and marketing authorization rights, to Click Therapeutics. To support this transition, Boehringer has made a $50M Series D strategic investment and provided dedicated commercial funding to help bring CT-155 to patients, if cleared by the FDA. CT-155 was co-developed by Boehringer and Click. "Boehringer Ingelheim’s selection of Click to deliver CT-155 to patients is powerful validation of our vision and the capabilities we have spent over a decade building," said David Benshoof Klein, CEO and founder of Click Therapeutics. "We are eager to take the lead with CT-155 and are focused on getting this FDA-designated Breakthrough Device to patients after clearance by the FDA.” Read the full release: https://lnkd.in/eiFVuF-4 #Schizophrenia #DigitalTherapeutics #PrescriptionDigitalTherapeutics

The Click team was in Florence, Italy to attend the Schizophrenia International Research Society (SIRS) Congress last week! Our Head of Product Management, Daniel Rimm, took the stage to present "Bridging the Translational Gap: Principles and Process in DTx for Schizophrenia," in which he shared Click’s approach to turning robust clinical methodology into digital tools that can reach patients when they need it, wherever they are. We're proud to be part of this community and grateful to our partners for the collaboration driving this work forward.

Click Therapeutics SVP of Clinical Development and Evidence Generation, Viveca Livezey, MD, FAAN, was interviewed by Healthcare Brew's Caroline Catherman to discuss how we're building rigorously validated digital treatments, and why, in the era of AI, clinical guardrails are more necessary than ever. Dr. Livezey shares how her team translates principles from cognitive neuroscience and behavioral science into smartphone-based treatments, each held to rigorous clinical standards consistent with those for traditional medical interventions. Every trial is designed around endpoints that reflect how a patient feels, functions, and survives. As Dr. Livezey says, “The future isn’t about limiting AI in healthcare—it’s about ensuring it’s developed and deployed responsibly as a clinically grounded tool that extends care, rather than replaces it.” Read the full interview below: https://lnkd.in/eHCfseam #DigitalTherapeutics #DigitalHealth #HealthTech #HealthcareAI #AI