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PhysIQ announced today that it has entered into a strategic partnership with InCarda Therapeutics.
Newark, California-based InCarda Therapeutics develops first-of-its-kind respiratory therapies to treat cardiovascular disease.
According to a news release, Syneos Health has recommended PhysIQ patient monitoring technology for InCarda’s clinical trial 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 speed up the early diagnosis and registration of 400 patients in 100 clinical sites in Europe and North America.
“Speed is a critical factor in this groundbreaking experimental design,” PhysiQ CMO Dr. Steve Steinhüble said in the release. Using wearable data transmission and our FDA-cleared algorithm to confirm AF symptoms, we can enroll eligible patients and verify drug delivery endpoints within hours. With three biopharmaceutical leaders coming together to address this widespread health issue in new ways, our hope is to bring AF patients a simple and convenient treatment to safely and quickly relieve their symptoms.
How the partnership works
Once a patient in the study experiences a suspected AFIb event, they self-apply the PhysiQ-provided biosensor patch to confirm the AFIb diagnosis and direct the patient to the nearest InRhythm testing site. They were then clinically diagnosed with persistent AF using ECG and physical examination for study eligibility assessment.
If eligible, patients were randomly assigned to receive active or vehicle-matched placebo inhalation. The PhysIQ platform remains an integral part of the protocol to continuously monitor participants for efficacy and safety up to 90 minutes after dosing.
Using real-time remote monitoring of AFib patients allows caregivers to quickly initiate and safely maintain the most appropriate treatment regimen for the long term.
“Partnering with physIQ and Syneos Health has enabled us to develop and execute a patient-centered strategy for the recently initiated Phase 3 program of oral flecainide in AFib acute myocardial infarction,” said Encarda CMO Dr. Louise Belladinelli. “We have begun enrolling patients, which will provide us with a level of access to patients who need this treatment.”
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