AbbVie, Janssen, Novartis, Pfizer and UCB to jointly advance 'digital' endpoint for atopic dermatitis
As the competition around the lucrative atopic dermatitis space heats up, AbbVie, Janssen, Novartis, Pfizer, and UCB are coming together in a pre-competitive collaboration to advance nocturnal scratch as a “digital” endpoint for the skin condition.
The Big Pharmas are hoping to drive the broader acceptance of nocturnal scratch as a meaningful endpoint for atopic dermatitis, and for digital endpoints in general.
Pfizer researchers published a paper in March in a Nature partner journal, in which they explain how wearable sensors “can provide novel, objective measures of nighttime scratching and sleep; however, many current approaches were not designed for passive, unsupervised monitoring during daily life. In this work, we present the development and analytical validation of a method that sequentially processes epochs of sample-level accelerometer data from a wrist-worn device to provide continuous digital measures of nighttime scratching and sleep quantity.”
Pfizer faces an increasingly crowded atopic dermatitis space as AbbVie’s blockbuster Rinvoq is currently under FDA review for the indication, and according to SVB Leerink biotech analyst Geoffrey Porges, “looks spectacularly effective at its highest dose.” But he said Pfizer’s abrocitinib, its next-gen follow-up on Xeljanz, “continues to look meh.”
The collaboration between the companies is a bit of an exploratory mission too as the FDA has never authorized or approved any new medical products on the basis of these digital endpoints, which are defined as endpoints that use sensors to capture existing measures in a new way, according to an op-ed by Jen Goldsack, CEO of the Digital Medicine Society.
DiMe is helping these five biopharma companies in their collaboration and believes that digital endpoints present an opportunity to provide “a more meaningful and complete understanding” of patients’ conditions and responses, and potentially reduce the time and cost of bringing new therapies to market.
But for the FDA, which doesn’t use the term “digital endpoint,” the challenges of capturing patient-reported outcomes are numerous, and can include everything from the instrument used appropriately in the trial, to how the sponsor adequately measured the results, which are often conveyed in a “score,” and may be difficult to understand the magnitude of the benefit, particularly in relation to safety risks, according to an FDA presentation.
Diane Stephenson, executive director of the Critical Path for Parkinson’s, also explained some of the confusion around digital endpoints at a patient-focused drug development workshop in 2019 at FDA.
“I’ve been told many times that people think that if you use an FDA cleared device or an approved device – 510(k) cleared device — then that automatically means that that device will be accepted as an endpoint, a digital endpoint in a trial, so that’s incorrect,” she said.
“As we’ve heard today many times that definitions of how to define what would be achieved with an endpoint are quite unique,” she noted, while pointing to the FDA’s formal qualification process for drug development tools. “So this is just some really important grounding that we try to continue to remind, especially sponsors who are selecting digital tools for use primarily as exploratory endpoints, but their goal really is a digital endpoint in a trial,” Stephenson said.