physIQ Announces Collaboration with InCarda Therapeutics and Syneos Health to Accelerate Innovative Phase III Restore-1 Study in Patients with Atrial Fibrillation

Revolutionary trial design incorporates wearable sensors, FDA-cleared biomarkers and near real-time data to screen, enroll and track patients more quickly. The physIQ platform will support efficacy and safety evaluation of orally inhaled AF treatment which could mean more rapid restoration of normal sinus rhythm and symptom relief.

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Summation

  • 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.
  • 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.
  • SYNH), the only fully integrated biopharmaceutical solutions organization, recommended physIQ's innovative monitoring solution to help advance InCarda's clinical study of InRhythm™ (orally inhaled flecainide) in patients with atrial fibrillation (AF) – one of the most common heart arrhythmias that affects one in four adults over the age of 40.

A leader in continuous remote patient monitoring and data analytics, physIQ today announced a strategic collaboration with InCarda Therapeutics, Inc., a privately-held, clinical-stage biopharmaceutical company developing first-of-their-kind inhaled therapies for cardiovascular diseases.

Syneos Health® (Nasdaq:SYNH), the only fully integrated biopharmaceutical solutions organization, recommended physIQ’s innovative monitoring solution to help advance InCarda’s clinical study of InRhythm™ (orally inhaled flecainide) in patients with atrial fibrillation (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 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.

 

 

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