Digital therapeutics 2023: Swing and trial partner Curavit kick off fibromyalgia study

After the boom-and-bust cycling in digital therapeutics over the past few years, digital health providers are looking for 2023 to be a stabilizing year. Two of those companies are digital therapeutics developer Swing Therapeutics and all-virtual CRO Curavit Clinical Research.

The pair are currently enrolling a trial for Swing’s Stanza, a prescription smartphone DTx for fibromyalgia. The cognitive behavioral therapy treatment, which received a breakthrough device designation from the FDA in 2021, became available for patients in September, alongside the formal clinical trial which will finish enrollment soon with the study set to complete in the third quarter.

“This is the first of multiple digital therapeutics for us. We’re targeting other chronic pain conditions that can be related to fibromyalgia – central sensitization syndromes is what they’re called,” Swing Therapeutics CEO Mike Rosenbluth said in an interview.

Swing is taking a different approach in digital therapeutics to help advance adoption. It’s developed an affiliated physician-owned telemedicine clinic, Swing Care, to “bridge the gap between patient awareness and access to Stanza,” Rosenbluth said.

For Swing, instead of creating a big salesforce to go out and educate physicians, patients can access Stanza, if appropriate, directly through the dedicated clinic, he said.

Another innovation is its use of virtual clinical trials through Curavit. Swing is Curavit’s tenth digital therapeutics client in fewer than six months, said Joel Morse, Curavit co-founder and CEO, with DTx companies making up about half of its client base.

Curavit has engineered a way for patients to never have to go to physical sites. While the Swing fibromyalgia study participants do have an option to participate in-person and digitally, the Curavit enrollees join the trial and engage with study coordinators and investigators entirely through telehealth.

Rosenbluth said Swing did have questions about running trials remotely and an initial concern that engagement might not be as high with patients never having to show up somewhere. That hasn’t been the case, though.

“Patients participating from Curavit’s site are just as engaged or even more so than the average patient in our studies in terms of compliance, patient reported outcomes and with the digital therapeutic itself,” he said.