Flecainide

New Data From iRhythm Reinforce the Utility of Long-Term Ambulatory Cardiac Monitoring for Increased Diagnostic Yield and Improved Diagnostic Accuracy of Actionable Arrhythmias

Retrieved on: 
Monday, May 22, 2023

These new data reinforce the body of clinical evidence that long-term ambulatory cardiac monitoring of up to 14 days with Zio® XT increases diagnostic yield and improves diagnostic accuracy of ventricular arrhythmias across a wide range of patient populations.

Key Points: 
  • These new data reinforce the body of clinical evidence that long-term ambulatory cardiac monitoring of up to 14 days with Zio® XT increases diagnostic yield and improves diagnostic accuracy of ventricular arrhythmias across a wide range of patient populations.
  • Early detection and diagnosis are crucial to treating these arrhythmias and preventing adverse health outcomes.
  • At least seven days of continuous ambulatory ECG monitoring, performed by the Zio service, was necessary to achieve >95% accuracy in burden categorization.
  • In this randomized, placebo-controlled, crossover trial of 41 patients that received Zio XT ambulatory ECG monitoring for seven days, Flecainide significantly reduced PVC burden.

Mark Y. Lee, M.D., Named Medical Director of Electrophysiology at MemorialCare Heart & Vascular Institute at Long Beach Medical Center

Retrieved on: 
Thursday, January 19, 2023

LONG BEACH, Calif., Jan. 19, 2023 /PRNewswire/ -- Mark Y. Lee, M.D ., FACC, has been named medical director of electrophysiology at MemorialCare Heart & Vascular Institute at Long Beach Medical Center .

Key Points: 
  • LONG BEACH, Calif., Jan. 19, 2023 /PRNewswire/ -- Mark Y. Lee, M.D ., FACC, has been named medical director of electrophysiology at MemorialCare Heart & Vascular Institute at Long Beach Medical Center .
  • As the new medical director of electrophysiology, Dr. Lee will work to further Long Beach Medical Center's efforts for electrophysiology clinical research and education.
  • "Dr. Lee has done amazing work to date at MemorialCare Heart & Vascular Institute at Long Beach Medical Center, and we are excited to have him take on this new role as medical director of electrophysiology," says Joe Kim, M.D., chief medical officer, MemorialCare Long Beach Medical Center.
  • "I was born at Long Beach Medical Center, so serving my local community these past seven years as an electrophysiologist has been a blessing," says Dr. Lee.

Final Results from Phase 2 INSTANT Trial of InRhythm™ for the Treatment of Newly Diagnosed and Recurrent Paroxysmal Atrial Fibrillation Presented at 2022 American Heart Association Scientific Sessions

Retrieved on: 
Monday, November 7, 2022

SAN FRANCISCO, Nov. 07, 2022 (GLOBE NEWSWIRE) -- InCarda Therapeutics, Inc. (“InCarda”), a privately-held biopharmaceutical company developing inhaled therapies for cardiovascular diseases, today announced that final data from the company’s Phase 2 INSTANT trial of InRhythm (orally inhaled flecainide) were presented at the 2022 American Heart Association Scientific Sessions. The results were featured in a poster presentation entitled, “Orally Inhaled Flecainide for the Conversion of Recent-Onset, Symptomatic Atrial Fibrillation to Sinus Rhythm: Final Results from the Phase 2 INSTANT Trial,” at the conference, which is being held November 5-7, 2022 in Chicago.

Key Points: 
  • Final data demonstrated a conversion rate of approximately 47%, with a median time to conversion of less than 14 minutes from start of inhalation.
  • By Day 5, nearly all patients (97.3%) who converted to SR remained in SR without further treatment.
  • We are pleased to share the final results from the INSTANT study with the scientific community at the 2022 AHA Scientific Sessions.
  • The companyslead development product, InRhythm, is in Phase 3 development to treat acute episodes of PAF, a prevalent atrial arrhythmia.

InCarda Therapeutics Announces Execution of Planned CEO Transition to Drive Next Phase of Corporate Growth

Retrieved on: 
Tuesday, October 4, 2022

SAN FRANCISCO, Oct. 04, 2022 (GLOBE NEWSWIRE) -- InCarda Therapeutics, Inc. (“InCarda”), a privately-held biopharmaceutical company developing inhaled therapies for cardiovascular diseases, today announced the appointment of Robert Lisicki as chief executive officer and a member of the company’s board of directors. Grace E. Colón, Ph.D., who has served as president, CEO and member of the board for nearly ten years, is moving on from the company as part of a planned leadership transition. Dr. Colón, who intends to pursue other leadership opportunities within the life science space, will serve as a consultant to InCarda to ensure a smooth transition. The leadership transition reflects the company’s continued maturation, highlighted by its shifting focus toward preparations for potential commercial activities, as well as plans for strategically accessing the public markets when appropriate.

Key Points: 
  • Grace E. Coln, Ph.D., who has served as president, CEO and member of the board for nearly ten years, is moving on from the company as part of a planned leadership transition.
  • Dr. Coln, who intends to pursue other leadership opportunities within the life science space, will serve as a consultant to InCarda to ensure a smooth transition.
  • InCarda Therapeutics, Inc. is aprivately-held, clinical-stagebiopharmaceutical company developing first-of-their-kind inhaled therapies for acute cardiovascular diseases and conditions.
  • The companyslead development product, InRhythm, is in Phase 3 development to treat acute episodes of PAF, a prevalent atrial arrhythmia.

InCarda Therapeutics Announces Enrollment of First Patient in Pivotal Phase 3 RESTORE-1 Trial of InRhythm™ for the Treatment of Paroxysmal Atrial Fibrillation

Retrieved on: 
Tuesday, July 26, 2022

SAN FRANCISCO, July 26, 2022 (GLOBE NEWSWIRE) -- InCarda Therapeutics, Inc. (“InCarda”), a privately-held biopharmaceutical company developing inhaled therapies for cardiovascular diseases, today announced enrollment of the first patient in the company’s pivotal Phase 3 RESTORE-1 clinical trial of InRhythm™ (orally inhaled flecainide) in patients with newly-diagnosed atrial fibrillation (AF) or recurrent paroxysmal atrial fibrillation (PAF). At an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA), InCarda received FDA concurrence that this single Phase 3 trial would be acceptable to support the filing of a New Drug Application (NDA) for InRhythm for the acute conversion of recent-onset AF to sinus rhythm (SR) under medical supervision.

Key Points: 
  • The study plans to enroll approximately 400 patients to receive InRhythm (n=300) or a vehicle-matched placebo inhalation solution (n=100).
  • The results of the Phase 2 INSTANT study give us confidence that the Phase 3 trial will demonstrate a favorable benefit-risk profile for InRhythm.
  • This dose-ranging study also identified the optimal dose of InRhythm (120 mg), which InCarda is studying in the pivotal Phase 3 RESTORE-1 study.
  • The companyslead development product, InRhythm, is in Phase 3 development to treat acute episodes of PAF, a prevalent atrial arrhythmia.

InCarda Therapeutics Announces Enrollment of First U.S. Patient in Phase 2 INSTANT Trial of InRhythm™ for Treatment of Atrial Fibrillation

Retrieved on: 
Tuesday, January 19, 2021

The results from the dose-ranging stage of the trial were recently presented at the American Heart Associations (AHA) Scientific Sessions 2020.

Key Points: 
  • The results from the dose-ranging stage of the trial were recently presented at the American Heart Associations (AHA) Scientific Sessions 2020.
  • InCarda Therapeutics in collaboration with clinical investigators reported that oral inhaled flecainide can safely and rapidly convert recent-onset PAF to normal sinus rhythm (NSR).
  • InCarda is currently conducting the INSTANT Phase 2 trial of InRhythm in patients with recent-onset PAF.
  • The companyslead development product, InRhythm, is in Phase 2 development to treat acute episodes of PAF, a prevalent atrial arrhythmia.

InCarda Therapeutics Presents Positive New Data from Phase 2 Study of InRhythm™ in Patients with Paroxysmal Atrial Fibrillation at American Heart Association Scientific Sessions 2020

Retrieved on: 
Friday, November 13, 2020

The results demonstrated the rapid achievement of therapeutic plasma levels (Cmax > 200 ng/mL) of flecainide via oral inhalation with InRhythm.

Key Points: 
  • The results demonstrated the rapid achievement of therapeutic plasma levels (Cmax > 200 ng/mL) of flecainide via oral inhalation with InRhythm.
  • Approximately 80% of patients who received the studys highest administered dose (120 mg) achieved a flecainide Cmax > 200 ng/mL.
  • For all study participants who reached these therapeutic plasma levels, nearly 50 percent achieved a successful conversion from PAF to NSR.
  • The companyslead development product, InRhythm, is in Phase 2 development to treat acute episodes of PAF, a prevalent atrial arrhythmia.