physIQ, InCardia Therapeutics Partner on Phase III Afib Study

physIQ is collaborating with InCarda Therapeutics Inc. to advance a Phase III clinical study on atrial fibrillation (AF). Syneos Health recommended physIQ’s monitoring solution to help advance InCarda’s clinical study of InRhythm (an orally inhaled flecainide) in patients with AF—one of the most common heart arrhythmias that affects one in four adults over the age of 40.¹

The Phase III RESTORE-1 study is highly innovative in its use of wearable sensors and the U.S. Food and Drug Administration (FDA)-cleared AF digital biomarker developed by physIQ. The physIQ platform captures real-world patient data in near real-time 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,” explained Steve Steinhubl, M.D., chief medical officer, physIQ. “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.”

The study protocol follows an efficient design. As soon as a patient experiences a suspected AF episode, they will self-apply a physIQ-provided biosensor patch which will confirm an AF diagnosis and direct the patient to the nearest trial site. There, they will be evaluated for study eligibility using an ECG and physical exam to clinically confirm ongoing AF. If eligible, the participant will be randomized to receive either the active or a vehicle-matched placebo inhalation solution. The physIQ solution will remain an inherent 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 III program of orally inhaled flecainide for acute cardioversion of recent-onset AF. We have already begun enrolling patients which brings us a step closer to potentially getting this treatment to patients who need it,” said Luiz Belardinelli, M.D., chief medical officer, InCarda.

AF is a serious condition that can occur without any warning signs and can result in life-threatening complications such as blood clots, stroke and heart failure if left untreated. The use of near real-time remote monitoring of patients with AF is important to ensure that they can promptly initiate and safely continue the most appropriate treatment regimen for them over the long term.

“We invited physIQ to collaborate with us on this study due to the unique value they add to the protocol that no one else can provide. Engaging patients in a trial of this type has traditionally been challenging because patients can’t fully diagnose their symptoms as AF. Using a biosensor combined with physIQ’s platform allows us to rapidly screen, qualify and enroll patients—bringing us steps closer to intervening that much earlier,” added Tammy D’Lugin-Monroe, RN, MA, vice president, Global Head, Therapeutic Strategy and Innovation, Syneos Health.

physIQ is the leader in digital medicine, dedicated to generating health insight using continuous wearable biosensor data and advanced analytics. Its enterprise-ready cloud platform continuously collects and processes data from wearable biosensors using a deep portfolio of FDA-cleared analytics. The company has published one of the most rigorous clinical studies to date in digital medicine and develops, validates, and achieves regulatory approval of artificial intelligence-based analytics. 

InCarda Therapeutics develops inhaled therapies for acute cardiovascular diseases and conditions. The company is leveraging the ability of inhaled therapy to deliver medicine in the “first pass” to cardiac tissue, presenting a small, but effective dose of drug directly to affected regions of the heart. This permits rapid-onset, lower off-target tissue exposure of the drug, lower exposure to cardiac tissue and, more importantly, has the potential to be patient self-administered in a non-medical setting (e.g., home). 

Syneos Health is a fully integrated biopharmaceutical solutions organization. 

Reference
¹ Lloyd-Jones DM, Wang TJ, Leip EP, et al. Lifetime risk for development of atrial fibrillation: the Framingham Heart Study. Circulation 2004; 110:1042-6.