Opinion: Drugs Are Becoming ‘Smarter.’ Here’s How

We all know that the pharma world has been taken by storm by the newest generation of obesity treatments; they are a hot topic in many companies’ earnings calls, executive interviews and strategy presentations. Pharma’s embrace of such waves of innovation is not new. It also occurred when immunotherapy first arrived, along with gene therapies for rare disease, and we see it each time the next blockbuster drug class is identified.

I predict another such wave will shortly arrive in the form of the digitization of pharma pipelines. Soon, each drug will have a “smart” dosage that combines a digital therapeutic with traditional pharmacotherapy—a software-enhanced drug. I have long held the belief that digital therapeutics will be prescribed alongside drugs to improve patient outcomes, leading me to found Click Therapeutics back in 2012 to develop, validate and commercialize software as prescription medical treatments for people with unmet medical needs. We have seen compelling indicators recently, including new clinical data and pharma companies expressing interest in integrating digital solutions into their overall portfolios, that indicate the standard of care will start to shift.

Pharma has an immense opportunity to digitize its pipelines. These software-enhanced drug therapies will respond and adapt to patients, whether through personalized digital treatments based on the needs and responses of each patient, responsive side effect management or adaptive dose titration. For example, a patient starting on GLP-1 therapy who self-reports a higher tolerance for side effects may engage in a more rapid dose titration accompanied by digital tools to ease side effect management. Another patient with less tolerance for side effects may escalate their dose more slowly, but therefore engage in more intensive digital behavioral therapy to supplement the slower biochemical effects.

Due to the immense value that software-enhanced drugs can offer to patients, I predict that pharmaceutical company pipelines will soon be evaluated by prescribers, payers and investors not only on the basis of their molecular assets but also for those assets’ digital counterparts.

PfizerForAll, a digital platform that launched in August, is designed to provide patients with seamless access to healthcare and wellness resources. Similarly, LillyDirect, a digital healthcare experience launched early in 2024, provides disease management resources and personalized support for patients in the U.S. living with obesity, migraine and diabetes. As pharma continues to grow its relationships with patients through digital channels, it will be a natural transition for companies to create patient-centric digital experiences that work in combination with their drug offerings.

Recent developments driving growth in this area make the advanced, AI-supported digitization of pharma pipelines inevitable. Specifically, the FDA’s draft guidance on Prescription Drug Use-Related Software (PDURS), issued in September 2023, enables “added benefit claims” tied to the use of software with drugs.

In other words, any added clinical benefit from the use of software with a drug can be featured right on the drug label, in the package insert. These combination therapies can thus be introduced as new e-formulations of both existing and in-development drugs, unlocking a clear pathway to market. The end result is that physicians will soon be able to offer medications that integrate a digital therapeutic. Payers may be more likely to cover software-enhanced drugs, as these treatments can provide real-time outcomes data and cost-offset insights that enable tailored treatments and more effective value-based care models.

Partnerships to develop software-enhanced drug therapies are already underway. Teva UK, working with tech-bio company Closed Loop Medicine, has invested in the development of personalized medicines, which will combine software as a medical device with Teva’s existing pipeline of drugs. Remepy is a new company that plans on developing combination products that combine traditional drugs with its digital treatments in therapeutic areas such as mild cognitive impairment (MCI) and Parkinson’s disease.

At Click Therapeutics, we recently announced the launch of a product that combines Click’s clinically validated digital therapeutic technology with pharmacotherapy, enabling pharma companies to create Software-Enhanced Drug treatments. This builds on our existing expertise in co-developing digital therapeutics with global pharmaceutical innovators. In collaboration with Otsuka, we developed Rejoyn, the first prescription digital therapeutic authorized by the FDA for the adjunctive treatment of major depressive disorder symptoms in adults ages 22 and older on antidepressant medication. In addition, CT-155, our investigational prescription digital therapeutic (PDT) designed to treat the negative symptoms of schizophrenia and co-developed by Boehringer Ingelheim, received Breakthrough Device designation from the FDA at the end of last year. These collaborations have laid the foundation for further opportunities between digital therapeutics developers and pharma companies.

The new generation of software-enhanced drugs will go far beyond what pharma has achieved with digital to date, leveraging the full potential of PDTs. Clinically efficacious molecules are made more desirable by adding the benefits of a cognitive or behavioral health component in the form of an accompanying PDT. These combination products will engage not only biochemical targets but also behavioral, cognitive and neurological ones in order to achieve superior clinical outcomes.

Evidence is critical to unlocking PDTs’ novel benefits. For example, in September, Click announced it met the primary endpoint—reduction in monthly migraine days—in the pivotal randomized, double-blind, controlled, decentralized trial of CT-132, our investigative prescription digital therapeutic for the preventive treatment of episodic migraine. Patients in the trial continued taking their existing migraine medications while using CT-132. At completion of the study, CT-132 showed a statistically significant reduction in monthly migraine days following 12 weeks of treatment compared to sham, with the treatment arm experiencing about three fewer monthly migraine days by end of treatment. It’s this level of validation that the system—pharma, payers, patients, regulators and others—is looking for.

Emerging clinical data on the use of PDTs in patients on background pharmacotherapy support their efficacy above and beyond what drugs alone can achieve. And since PDTs may add clinical benefits that both patients and prescribers value, they could open a gateway for pharma to build long-term, trusted relationships with each, driving persistence on treatment, portfolio loyalty and reduced switching as well as detailed, longitudinal real-world data insights. Software-enhanced drugs could thus provide value that goes far beyond a digital companion to offer a return on investment that is on par with a new formulation or even a new molecular entity.

With the FDA’s publication of the PDURS guidance, new opportunities have emerged. Drug-software combination products offer a new kind of treatment, one that is personalized to patients, improves outcomes and opens the door to building meaningful, long-term digital relationships. And given their applicability to entire pharma pipelines, PDTs will add value not only to this wave of innovation, but also to the next, and the next and the next.