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Click SE

Medicine just got a digital upgrade: Software-Enhanced Drugs™

Click SE™ solutions combine software with pharmacotherapy to create software-enhanced drug™ treatment options, targeting the unique needs of a specific medication to deliver added clinical benefit to patients.

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Combining drug and software,
creating added clinical benefit.

Click SE™: Creating a new standard of care

Click SE™ portfolio is pioneering a more personalized and patient-centric approach to treatment, seamlessly combining software with pharmacotherapy to create software-enhanced drug™ treatments.

Why this Matters

01

New PDURS Guidance from FDA means the time is now to pursue the potential of drug-software combination treatments.

Recent FDA Guidance states that added clinically meaningful benefit from the use of software with a drug can be added directly into the drug label, providing a clear regulatory pathway for integrating software with existing drug products.

02

Clinical data increasingly demonstrate that software-enhanced drug™ therapies close gaps in treatment and improve health outcomes for patients.

Results from two phase 3 randomized, controlled studies of CT-132 demonstrate clinically meaningful added benefit of software plus drug compared to drug alone.

03

The digitization of pharma pipelines enables a new type of continuous value creation, which can add to patient benefit over time.

Unlike stand-alone drugs, software improves over time, allowing for ongoing value creation for patients and providers. And since software-enhanced drug™ formulations apply across multiple indications in a portfolio, this creates a unique opportunity for entire pipelines to benefit from this new wave of innovation.

Defining The FutureofClinical Care.

It’s monumental for this space and could change the conversation for Pharma from “What’s your digital therapeutic strategy?” to “What’s your strategy to use digital therapeutics to improve the drug labels of your bestselling drugs?”

Click Therapeutics
Hear David Benshoof Klein, Founder & CEO, on the opportunities enabled by software-enhanced drug™ formulations.

We believe that software-enhanced drug™ formulations will change the pharmacotherapy landscape as we know it.

  • Improve formulary positioning and prescriber preference with superior clinical outcomes.
  • Enable the creation of measurable, data-driven value-based contracts for high-cost innovative therapies.
  • Build personal relationships with patients that can persist over time.
  • Collect de-identified real world data to generate new population-level insights.
  • Empower patients to be at the center of their own treatment by helping them take charge of their condition.
  • Deliver combined therapeutic impact on both biochemical targets (drugs) and neurocircuits and behavior (software).
  • Increase durability of treatment through long-lasting behavior change.
  • Transfer pharmacological outcomes (e.g., cognition, metabolic health) to adjacent domains (e.g., problem solving, daily function).
  • Pursue outcomes currently inaccessible to drug (e.g., mood, fatigue).
  • Accelerate clinical study recruitment and improve clinical study designs using data-driven insights.
  • Unlock a new domain of R&D to improve software-based drug™ treatment over time for continuous value creation.
  • Offer providers a new way to interact with and understand their patients.
  • Generate digital biomarkers to guide clinical decision making and clinical research.
  • Providing patients with new clinical benefits not targetable by drug.
  • Boosting persistence on treatment through engaging digital experience.
  • Drive significant incremental economic value to the healthcare system.
  • Provide patients with a differentiated treatment experience delivering superior health outcomes.
  • Creating rich, longitudinal real-world datasets optimized for AI/ML and population insights.

Why Click SE™

Click’s commitment to develop software as a medical device, only available by prescription, has uniquely positioned us to drive direct value through Click SE™ services and products.
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  1. Deep Experience Developing Regulated Treatments

    We have the required regulatory and quality controls and expertise in-house to develop software-enhanced drug™ therapies, globally.

  2. End-to-End Capabilities

    We have a cohesive development approach from strategic ideation through product development and clinical validation that integrates the best of biotech and software development.

  3. Shared Interest with our Partners and Stakeholders

    Because we are a digital biotech, not a contract manufacturer or a consulting firm, we are committed to the long-term success of our products and the industry.

  4. Proprietary Platform Approach

    We have spent over a decade building an ISO 13485-compliant platform that lets us develop new products efficiently, while still customizing to the needs of each patient population.

  5. The Partner-of-Choice

    We have a record of success in partnering with pharma, with ongoing collaborations with Otsuka, Boehringer-Ingelheim, and Indivior to develop regulated treatments in a variety of therapeutic areas.

Learn more

The Future of Smart Drugs: FDA’s New Guidance on Digital Therapeutics Could Revolutionize Pharma and Patient Care

Click Therapeutics

By Randall Stanicky

Chief Financial Officer

08.02.2024

PDURSClick SESoftware-Enhanced Drugs

The FDA’s PDURS Guidance: What Manufacturers Need to Know

Click Therapeutics

By Austin Speier

Chief Strategy Officer

08.01.2024

PDURSClick SESoftware-Enhanced Drugs

Regulating SaMD: Q&A With David Klein, Founder and CEO of Click Therapeutics

Click Therapeutics

Interview with David Benshoof Klein

Founder and CEO

10.10.2023

PDURSClick SESoftware-Enhanced Drugs

FDA Guidance May Jumpstart Digital Therapeutics Market from Oliver Wyman

Click Therapeutics

Interview with David Benshoof Klein

Founder and CEO

PDURSClick SESoftware-Enhanced Drugs

The Future of Smart Drugs: FDA’s New Guidance on Digital Therapeutics Could Revolutionize Pharma and Patient Care

Click Therapeutics

By Randall Stanicky

Chief Financial Officer

08.02.2024

PDURSClick SESoftware-Enhanced Drugs

The FDA’s PDURS Guidance: What Manufacturers Need to Know

Click Therapeutics

By Austin Speier

Chief Strategy Officer

08.01.2024

PDURSClick SESoftware-Enhanced Drugs

Regulating SaMD: Q&A With David Klein, Founder and CEO of Click Therapeutics

Click Therapeutics

Interview with David Benshoof Klein

Founder and CEO

10.10.2023

PDURSClick SESoftware-Enhanced Drugs

FDA Guidance May Jumpstart Digital Therapeutics Market from Oliver Wyman

Click Therapeutics

Interview with David Benshoof Klein

Founder and CEO

PDURSClick SESoftware-Enhanced Drugs

Collaborations

Redefining treatment innovation through collaborations

Click SE™ solutions are positioned to begin development of software-enhanced versions of both in-development and marketed drugs today, offering a new source of value to our collaborators and the patients they support.

A partner of choice, Click Therapeutics, works with mission aligned pharmaceutical partners to identify, develop, validate, and commercialize software-enhanced drug™ treatments. Click Therapeutics understands that it takes time and expertise to build clinically rigorous and highly engaging evidence-based treatments that deliver measurable clinical benefit to patients.

Ask us how we can help you get started today to prepare your organization for the future.

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Q&A

  • PDTs deliver evidence-based treatments directly to a patient via their smartphone in the form of a mobile app. With PDTs, the software is the treatment. PDTs are prescribed by a physician to treat a disease or condition, and as such are clinically validated and FDA-regulated, much like a medicine. PDTs can be used independently or in combination with traditional pharmaceutical treatments.
  • Click SE™ solutions offer a new approach to medicine, which combines software with pharmacotherapy to create software-enhanced drug™ treatments. We work with pharma to create “SE” (software-enhanced) formulations of their pipeline and marketed drugs that offer added clinical benefit. Click SE™ solutions build on Click’s proprietary AI-enabled platform and our deep experience developing regulated prescription digital therapeutic treatments with global pharmaceutical innovators.
  • Software-enhanced drug™ therapies target the unique needs of a medication and patient population to deliver added clinical benefit. Compared to other PDURS solutions, these treatments are differentiated by a high level of clinical rigor and offer patients an engaging and personalized treatment experience to achieve superior clinical outcomes, which are measured in clinical studies with gold standard endpoints and listed in the drug label.
  • In September 2023, the FDA released a new guidance document titled Regulatory Considerations for Prescription Drug Use-Related Software (PDURS). This guidance outlines how the FDA intends to apply its drug labeling authorities to software outputs associated with prescription drugs or drug-device combination products, covering a full spectrum of use cases. It provides clarity on when certain types of software can only be described in promotional labeling or when it is appropriate to include in the FDA-required labeling such as the package insert.
  • FDA specifies that evidence of added clinically meaningful benefit from the use of software with a drug compared to use of the drug alone (from one or more adequate and well-controlled clinical studies) can be included in the drug label. To meet this standard and deliver maximal value of PDURS to patients, pharma can prioritize software that complies with the requirements for software-as-a-medical-device (SaMD), can withstand regulatory scrutiny in premarket authorization filings, and consistently offer best-in-class engagement and clinical outcomes.
  • Click Therapeutics designs prescription digital therapeutics to deliver clinically meaningful benefits to patients. These therapeutic outcomes can be assessed by gold standard measures and can impact primary or secondary efficacy endpoints, safety, tolerability, or side effect management. For more information on how Click Therapeutics has demonstrated this benefit, see data from Click’s preventive migraine investigational prescription digital therapeutic here.
  • Click Therapeutics utilizes market and user research to develop prescription digital therapeutics that meet the needs of patients, providers and payers, ensuring maximal value delivery for the health system, whether offered independently or in combination with medication. Software-enhanced drug™ solutions can offer additional value by differentiating biomedical treatments in competitive therapeutic areas and extending franchise value with ongoing, iterative software releases that add new benefit for patients over time.
  • By introducing a new “SE” formulation, a pharma manufacturer can create a new treatment with a unique efficacy and safety profile, enabled by the proprietary software-based technologies and methods included in the digital therapeutic component of the treatment. This SE formulation - because it is digital - can be improved over time, yielding improved patient benefit as well as new intellectual property via novel R&D, technology platform improvements and real world learnings.

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