Remote patient monitoring and analytics leader physIQ and CRO Syneos Health are teaming up for a phase 3 trial of InCarda Therapeutics’ inhaled cardiovascular treatment InRhythm (flecainide) for patients with atrial fibrillation.
The phase 3 RESTORE-1 study is designed to use wearable sensors and the FDA-cleared afib digital biomarker developed by physIQ that captures patient data in near real time to speed prescreening and enrollment of 400 patients in 100 clinical sites across Europe and North America.
In mid-2021, InCarda reported phase 2 trialdata on its inhaled challenger to Pfizer’s intravenous anti-arrhythmic drug Corvert. Half of the subjects who received the inhaled drug converted from paroxysmal afib to sinus rhythm in the 90 minutes after the start of treatment. InCarda compared the result favorably to the 38% to 40% conversion rate cited on the label for Corvert.
The median time to conversion after the end of treatment with InCarda was eight minutes. No serious cardiovascular adverse events were seen.
As part of the phase 3 study, as soon as a patient experiences a suspected afib episode, they will self-apply a physIQ-provided biosensor patch that will confirm an afib diagnosis and direct the patient to the nearest trial site.
Eligible participants will get either the active or a vehicle-matched placebo inhalation solution. The physIQ solution will be part of the protocol for up to 90 minutes following initiation of dosing to continuously monitor participants for efficacy and safety.
“Partnering with physIQ and Syneos Health has allowed us to develop and execute a patient-centric strategy to support the Phase 3 program of orally inhaled flecainide for acute cardioversion of recent-onset AF,” Luiz Belardinelli, M.D., InCarda’s chief medical officer, said in a statement. “We have already begun enrolling patients which brings us a step closer to potentially getting this treatment to patients who need it.”