Remote patient monitoring specialist physIQ has announced a collaboration with clinical-stage biopharma InCarda Therapeutics, which is working on inhaled therapies for cardiovascular diseases. Life science tech provider Syneos Health recommended the use of physIQ’s monitoring solution on InCarda’s 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.
According to physIQ, the Phase III RESTORE-1 study is novel 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, physIQ chief medical officer. “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,” Steinhubl added.
The moment a patient enrolled in the study experiences a suspected AF episode, they are to self-apply a physIQ-provided biosensor patch, which then 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 a 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,” said Luiz Belardinelli, InCarda chief medical officer. “We have already begun enrolling patients which brings us a step closer to potentially getting this treatment to patients who need it.”
AF can occur without warning signs; it can lead to 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 can help ensure 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,” said Tammy D’Lugin-Monroe, vice president and global head of therapeutic strategy and innovation with Syneos Health. “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.”