Drugs are becoming “smarter.” Here's how

We all know that the pharmaceutical world has been taken by storm by the latest generation of obesity treatments; They are a hot topic in many companies' phone calls, executive interviews and strategy presentations. The acceptance of such waves of innovation by pharmaceutical companies is not new. This also happened when immunotherapy first came to market, along with gene therapies for rare diseases, and we see it every time the next blockbuster drug class is identified.

I expect another wave of this kind to arrive soon in the form of digitalization of pharma pipelines. Soon, every drug will have “smart” dosing that combines a digital therapeutic with traditional pharmacotherapy – a software-enabled drug. I have long believed that digital therapeutics should be prescribed alongside medications to improve patient outcomes. That's why I founded Click Therapeutics in 2012 to develop, validate and commercialize software as a prescription medical treatment for people with unmet medical needs. We have seen compelling indicators recently, including new clinical data and pharmaceutical companies expressing interest in integrating digital solutions into their overall portfolios, that suggest the standard of care is beginning to change.

Pharma has a huge opportunity to digitize its pipelines. These software-driven drug therapies respond and adapt to patients, whether through personalized digital treatments based on each patient's needs and responses, responsive side effect management, or adaptive dose titration. For example, a patient starting GLP-1 therapy and self-reporting a higher tolerance to side effects may perform faster dose titration, accompanied by digital tools to facilitate side effect management. Another patient with a lower tolerance to side effects may increase their dose more slowly, but therefore receive more intensive digital behavioral therapy to complement the slower biochemical effects.

Because of the immense value that software-enabled medicines can provide to patients, I expect that pharmaceutical company pipelines will soon be evaluated by prescribers, payers and investors based not only on their molecular assets, but also on the digital counterparts of those assets .

A digital transition

PfizerForAll, A digital platform launched in August aims to give patients seamless access to health and wellness resources. Similar, LillyDirecta digital health experience launching in early 2024, provides disease management resources and personalized support for patients in the U.S. suffering from obesity, migraines and diabetes. As the pharmaceutical industry continues to expand 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 advanced, AI-powered digitalization of pharma pipelines essential. In particular, the FDA's draft guidance on Prescription medication use software (PDURS), issued in September 2023, allows for “additional benefit claims” related to the use of software with medications.

In other words, any additional clinical benefit from using software with a drug can be reported directly on the drug label in the package insert. These combination therapies can therefore be introduced as new e-formulations of both existing and under-development drugs, providing a clear path to market launch. The end result is that doctors will soon be able to offer medicines that integrate a digital therapeutic. Payers may be more likely to adopt software-enabled medicines because these treatments can provide real-time outcomes data and cost adjustment insights that enable tailored treatments and more effective value-based care models.

Partnerships to develop software-based drug therapies already exist. Teva UK has invested in the development of personalized medicines in collaboration with technology bio company Closed Loop Medicine, which will combine software as a medical device with Teva's existing drug pipeline. Remepy is a new company that aims to develop combination products that combine traditional medications 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 therapy technology with pharmacotherapy, enabling pharmaceutical companies to develop software-assisted 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 approved by the FDA for the adjunctive treatment of symptoms of major depressive disorder in adults 22 years of age and older taking antidepressants. Additionally, CT-155, our prescription digital therapeutic (PDT) co-developed by Boehringer Ingelheim to treat the negative symptoms of schizophrenia, received Breakthrough Device designation from the FDA late last year. These collaborations have laid the foundation for further opportunities between digital therapeutics developers and pharmaceutical companies.

An increase in clinical outcomes

The new generation of software-enabled medicines will go far beyond what the pharmaceutical industry has previously achieved through digital means and realize the full potential of PDTs. Clinically effective molecules become even more desirable with the addition of the benefits of a cognitive or behavioral health component in the form of a concomitant PDT. These combination products target not only biochemical, but also behavioral, cognitive and neurological targets to achieve better clinical outcomes.

Evidence is critical to unlock the novel benefits of PDTs. For example in September: Click announced It met the primary endpoint of reduction in monthly migraine days in the pivotal, randomized, double-blind, controlled, decentralized study of CT-132, our investigational prescription digital drug for the preventive treatment of episodic migraine. Patients in the study continued to take their existing migraine medications while using CT-132. At the end of the study, CT-132 demonstrated a statistically significant reduction in monthly migraine days after 12 weeks of treatment compared to sham treatment, with the treatment arm having approximately three fewer monthly migraine days by the end of treatment. It is this level of validation that the system – pharma, payers, patients, regulators and others – is looking for.

New clinical data on the use of PDTs in patients on background drug therapy demonstrate their effectiveness beyond what drugs alone can achieve. And because PDTs can provide clinical benefits valued by both patients and prescribers, they could provide a gateway for the pharmaceutical industry to build long-term, trusting relationships with both, thereby increasing treatment persistence, portfolio loyalty and reducing switching and promote detailed, longitudinal real-world outcomes. Insights into world data. Software-assisted medicines could therefore offer added value that goes far beyond a digital companion and offer a return on investment comparable to a new formulation or even a new molecular entity.

With the FDA's publication of the PDURS guidelines, new opportunities have emerged. Drug-software combination products offer a new way to deliver care that is tailored to the patient, improving outcomes and opening the door to building meaningful, long-term digital relationships. And because PDTs are applicable to entire pharma pipelines, they will add value not only to this wave of innovation, but also to the next one, and the next, and the next.