physIQ Announces Collaboration with InCarda Therapeutics and Syneos Health to Accelerate Innovative Phase III Study in Patients with Atrial Fibrillation

The Phase III RESTORE-1 study is highly innovative in its use of wearable sensors and the 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, MD, 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 innovative and 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 3 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, MD, 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.

# # #

About physIQ

physIQ is the leader in digital medicine, dedicated to generating unprecedented health insight using continuous wearable biosensor data and advanced analytics. Its industry-leading, 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 are pioneers in developing, validating, and achieving regulatory approval of Artificial Intelligence-based analytics. With applications in both clinical trial support and healthcare, physIQ is transforming continuous physiological data into insight for health systems, payers, and pharmaceutical companies. For more information, please visit www.physIQ.com. Follow us on Twitter and LinkedIn.

About InCarda Therapeutics, Inc.

InCarda Therapeutics, Inc. is a privately-held, clinical-stage biopharmaceutical company developing first-of-their-kind 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). InCarda employs a de-risked approach by using approved drugs with a long history of efficacy and safety as candidates for the new dosing paradigm via inhalation. The company’s lead development product, InRhythm, is in Phase 3 development to treat acute episodes of PAF, a prevalent atrial arrhythmia. For more information, please visit: www.incardatherapeutics.com.

About Syneos Health

Syneos Health^® (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, strategically blending clinical development, medical affairs and commercial capabilities to address modern market realities.

We bring together more than 29,000 minds, across more than 110 countries, with a deep understanding of patient and physician behaviors and market dynamics. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients.

Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment.

To learn more about how we are Shortening the distance from lab to life^®, visit syneoshealth.com or subscribe to our podcast.

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