Newark, California–based InCarda Therapeutics develops first-of-their-kind inhaled therapies for treating cardiovascular diseases.
According to a news release, Syneos Health recommended PhysIQ’s patient monitoring technology to help advance InCarda’s clinical study of InRhythm (orally inhaled flecainide) in patients with AFib.
The Phase III Restore-1 study uses wearable sensors and PhysIQ’s FDA-cleared AFib digital biomarker to capture real-world patient data in near-real-time. The goal is to accelerate the speed of pre-screening and enrollment of 400 patients in 100 clinical sites across Europe and North America.
“Speed is a critical factor throughout in this groundbreaking trial design,” PhysIQ CMO Dr. Steve Steinhubl said in the release. “Using wearable data transmission and our FDA-cleared algorithm to confirm AF symptoms, we can enroll eligible patients and validate drug delivery endpoints within just hours. With three biopharmaceutical leaders converging to tackle this widespread health issue in an innovative way, our hope is to bring AF patients an easier, more convenient treatment to alleviate their symptoms safely and rapidly.”
How the partnership works
As soon as a patient in the study experiences a suspected AFib episode, they will self-apply a PhysIQ-provided biosensor patch to confirm an AFib diagnosis and direct the patient to the nearest InRhythm trial site. They will then receive evaluations for study eligibility using an ECG and physical exam to clinically confirm ongoing AF.
If eligible, patients randomly receive either the active or a vehicle-matched placebo inhalation. PhysIQ’s platform remains an inherent part of the protocol for up to 90 minutes following initiation of dosing to continuously monitor participants for efficacy and safety.
The use of near-real-time remote monitoring of AFib patients allows caregivers to ensure that they can promptly initiate and safely continue the most appropriate treatment regimen for them over the long term.
“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 AFib,” InCarda CMO Dr. Luiz Belardinelli said. “We have already begun enrolling patients which brings us a step closer to potentially getting this treatment to patients who need it.”