ARTICLE SUMMARY:
Alzheimer’s disease has long been the sole province of pharmaceutical and biotech companies, but digital therapeutics companies aim to work their way into the conversation. Excerpted from our recent MedTech Strategist feature.
Alzheimer’s disease has been in the headlines again with more chatter about Aduhelm (aducanumab), Biogen Inc.’s biologic for early-stage Alzheimer’s disease. When FDA approved it (conditionally) in June 2021, it was the first drug in a new therapeutic class to have gained FDA approval since 2003. It’s also the first disease-modifying—rather than symptom-treating—drug to gain approval. Aduhelm is a monoclonal antibody that works by clearing out amyloid plaque deposits, which are thought to contribute to the development of cognitive deficits and dementia, and as such, has the potential to alter the progression of the disease.
The current news revolves around Medicare’s preliminary decision to restrict payment for Aduhelm (an annual maintenance dosing regimen that costs $28,000) just to patients enrolled in FDA-approved randomized controlled clinical trials, a stance that recognizes the high risk-benefit profile of the drug. While this is mixed news for the pharmaceutical industry, where at least six more monoclonal antibody (mAb) drugs for Alzheimer’s disease are coming up the pike it’s largely good news for the Alzheimer’s community. FDA has shown an eagerness to support disease-modifying drugs for AD, while Medicare has used its clout to add a layer of patient safety.
For developers of digital therapeutics for AD, these recent conversations are clearly good news, because they highlight both the need for new treatments and the safety issues of drugs. Says Brent Vaughan, CEO of Cognito Therapeutics Inc., “The last six months has been one of the most exciting and innovative times to be in Alzheimer’s in the past two decades.”
Cognito Therapeutics is developing what it calls a digital therapeutic for Alzheimer’s, which is used by patients in their homes and has a software interface that helps with patient compliance and data collection. It’s also a medical device that delivers what appears to be disease-modifying electrical stimulation.
Digital therapeutics company Brain+ A/S is after a different kind of brain stimulation—stimulating conversation, in a way—through technology-enabled cognitive stimulation therapy, which has been shown to measurably improve dementia.
Digital therapeutics have unique benefits to offer the field, starting with access. Kim Baden-Kristensen, co-founder and CEO of Brain+, says that while many patients with dementia can’t get to clinics, everyone can download an app from the App store. Economics also influence access, and there is perhaps a more important point to make about the promise of digital therapeutics: the ability to intervene earlier in the course of neurological disease.
Other advantages of digital therapeutics include safety and the collection of data, which can lead both to greater understanding of disease processes and personalization of therapy. Further, these noninvasive devices potentially operate by mechanisms of action that don’t clash with pharmaceutical therapies, and they don’t suffer from the greatest limitation of drugs: the challenge of getting therapy across the blood-brain barrier without causing systemic toxicity.
In many cases, the safety profiles of digital therapeutics allow companies to conduct clinical trials on smaller patient populations, reducing development costs and shortening time to clinical proof.
Digital therapeutics companies require hybrid skill sets; they might combine devices that provide monitoring or therapy, but act like pharma in understanding and targeting specific mechanisms of action. But the business models of the three categories are as unlike as could be. Cognito’s Brent Vaughan noted that digital therapeutics offer a data and software-enabled business model that includes continuous evolution and improvement, “whereas pharma and biotech models have historically been built on patent lifecycle, usually 15 years from launch.”
Apple’s iPhone was launched exactly 15 years ago, he pointed out. “And no one is worrying about replacing X billion dollars of revenues because their phone went off patent, because it continues to evolve. And the more users you get, the stronger your product gets.” The same is true of software and data-enabled therapeutic platforms, Vaughan continued, “because the more users and data you get, the better you can address variability between patients and within a patient over time, which means that ultimately you will move from a patent-cliff-based model to a data-based business model.” Vaughan added, “If there was a finite number of receptors driving the etiology of Alzheimer’s disease, we would have cracked this 20 years ago. There is a lot of heterogeneity and variability among these patients.”
Ultimately, the distinction, for a complicated and underserved disease like Alzheimer’s, isn’t “either-or.” Digital therapeutics provide a new option in a treatment armamentarium that can be efficacious on a stand-alone basis, or they can safely layer onto other therapies to improve their efficacy.
Excerpted from “Digital Therapeutics for Alzheimer’s Blur Industry Boundaries,” MedTech Strategist, January 20, 2022.