Digital pills, aka ‘ingestible sensors’, are at a crossroads

EtectRx, one of a handful of companies pursuing what has variously been called “digital medicine,” “digital pills” and “ingestible sensors,” has appointed Valerie Sullivan as president and CEO, an executive experienced in patient support functions, and is going forward with its ID-Cap System for monitoring patients taking oral drugs.

Meanwhile, over the summer, a dramatic confrontation has played out among investors in Proteus Digital Health, one of the pioneering firms of this technology. Having reached a market capitalization of $1.5 billion at one point (and absorbing some $420 million of investor funds), a bankruptcy judge approved the sale of the company to Otsuka Pharmaceuticals, one of its investors (and customers), for all of $15 million. Other investors, including Novartis, had contended the price was a fire sale and that the company’s 600-some patents were worth considerably more, but the bankruptcy judge disagreed.

EtectRx’s Sullivan says that in contrast to Proteus and other companies in the digital pill arena, her company’s focus is almost exclusively on patient adherence, in both clinical trials and commercial brands. “This pandemic era we’re in has ramped up interest in telehealth generally,” she says. “The remote patient monitoring that ID-Cap System enables can reduce clinical trial costs, eliminate non-adherence among patients and allow for real-time intervention with them.” Once the EtectRx capsule is swallowed, a signal of that event is received (via a wearable reader that transmits to a smartphone) by a clinician within six minutes.

EtectRx has four NIH-sponsored trials running or about to start up, involving HIV treatment or prevention and a variety of shorter- and longer-term adherence studies. Looking ahead, Sullivan says that a strong opportunity should exist for oral oncology drugs, which can have highly specific treatment regimens.

There are other ingestible sensor developers, including implantable drug delivery mechanisms or diagnostic medical devices, each with a goal to provide signals while analyzing patient response. Otsuka’s interest in Proteus has been based on Abilify-MyCite (aripiprazole tablets with sensor), for various mental-health conditions. Meanwhile, adherence continues to be a problem across the board for pharma, with getting and keeping patients on therapy still a significant factor in healthcare despite years of efforts to counter noncompliance.