Study Finds 89% of Patients Treated for Persistent Atrial Fibrillation Using Abbott's Ablation Device Remain Symptom-Free for at Least 15 Months

  • Treatment with the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ resulted in patients with persistent atrial fibrillation experiencing an improved quality of life
  • The catheter is part of Abbott's suite of electrophysiology solutions designed to improve procedures to address cardiac arrythmias

Abbott (NYSE: ABT) today announced results from the PERSIST-END study, which showed that nearly nine out of 10 patients (89%) treated for persistent atrial fibrillation (AFib) with the company's TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) remained symptom-free for up to 15 months following the procedure. The data, which is being presented at the annual meeting of the Heart Rhythm Society April 29 May 1 also showed that due to the more effective therapy, patients reported significant quality-of-life improvements and more than 50% reduction in the use of health care resources.

Millions of Americans are affected by abnormal heart rhythms, known as arrhythmias, caused by breakdowns in the electrical pathways of the heart. Left untreated, these breakdowns can lead to erratic heartbeats or cause the heart to beat too fast or too slow, which can dramatically impact a person's health. AFib, the most common arrhythmia, is a condition in which the heart's chambers are out of sync, causing them to beat in a rapid and chaotic fashion. Persistent AFib is a type of arrhythmia that lasts anywhere from one week to a year. If left untreated, AFib may eventually lead to heart failure or stroke.

"Like many arrhythmias, persistent AFib can be difficult to treat and to date we have had relatively few approaches approved specifically to treat this condition," said Douglas Gibson , M.D., site principal investigator and director of cardiac electrophysiology at Scripps Clinic and the Prebys Cardiovascular Institute in San Diego, Calif. "The results of the PERSIST-END study show that Abbott's TactiCath SE can help physicians ensure the majority of our persistent AFib patients will remain symptom-free following their therapy and will go on to experience dramatic improvements in their quality of life."

AFib is categorized into three types: paroxysmal, persistent or long-standing persistent. Paroxysmal is defined as an abnormal heart rhythm that lasts for less than a week, persistent lasts between one week to a year, and long-standing persistent lasts longer than a year. Approximately half of patients with AFib have a long-standing persistent heart rhythm issue while the remaining 50% are equally divided between paroxysmal and persistent. 1 TactiCath SE was previously approved for paroxysmal AFib and the data from the PERSIST-END study supported approval of the additional indication in persistent AFib in 2021.

TactiCath SE is used as part of a cardiac ablation procedure, a minimally invasive method that allows doctors to treat the condition at the source by selectively disrupting the area of the heart generating abnormal heart beats. The catheter provides doctors essential and immediate feedback when the tip of the ablation catheter connects with the tissue within the heart, which can help improve accuracy and consistency of the procedure. It is used in conjunction with Abbott's EnSite™ X EP System, the Advisor™ HD Grid Mapping catheter, and EnSite Omnipolar Technology (OT).

"Ablation therapy is an increasingly important option for people living with cardiac arrhythmias because it allows physicians to treat the cause of the arrhythmia at its source. However, it can be a challenging procedure because the right amount of pressure needs to be applied to the heart wall to be effective, but not so much as to cause other problems," said Christopher Piorkowski , M.D., chief medical officer of Abbott's electrophysiology business. "We developed TactiCath SE to provide clear information on whether the device is making contact with the heart wall and whether the pressure is enough to achieve the therapeutic goals. The outcomes are clear – the system delivers safe and effective results."

About PERSIST-END
PERSIST-END was a prospective, multi-center, single-arm clinical trial that included 224 patients from 21 investigational sites in the U.S. and Australia conducted from 2018 to 2021. Patients were evaluated for 15 months following the cardiac ablation procedure for safety, efficacy, and quality of life measures.

The primary safety endpoint for the trial was defined as the rate of primary device and/or procedure-related serious adverse events (SAEs) occurring within seven days of any ablation procedure. Primary efficacy was defined as freedom from documented AFib, atrial flutter or tachycardia >30 seconds or longer, new or increased dose of Class I/III antiarrhythmic drug (AAD), repeat ablation, and cardioversion through 15 months of follow-up.

The trial met all of its primary safety, effectiveness and quality of life endpoints. The rate of serious adverse events was 3.1%, which is consistent with other studies in the persistent AFib population. In addition, the overall primary effectiveness endpoint found that 61.6% of patients remained free from arrhythmia recurrence, any new or increased Class I/III AAD, repeat ablation or cardioversion.

The study further found that participants reported that their Atrial Fibrillation Effect on the QualiTy-of-life (AFEQT) score increased by more than 27 points after three months and more than 32 points after 15 months – a clinically important difference resulting in an average 91.9 quality of life score on a 100-point scale 15 months after the procedure. Similarly, the patients' average annual overall cardiovascular-related health care utilization decreased by 53% in the 15 months following ablation compared to pre-ablation utilization.

About Cardiac Ablation
When physicians use ablation to treat cardiac arrhythmias, long flexible tools — called catheters — are inserted into the heart to study the arrhythmia and to deliver radio frequency energy. Heat generated from the radio frequency energy disrupts the cells that are creating the abnormal heart rhythm. As a result, this tissue is no longer capable of conducting or sustaining the arrhythmia.

For U.S. important safety information on the TactiCath Contact Force Ablation Catheter, Sensor Enabled, visit: https://www.cardiovascular.abbott/us/en/hcp/products/electrophysiology/ablation-technology/tacticath-se-ablation-catheter/indications-safety-warnings.html .

About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com , on LinkedIn at www.linkedin.com/company/abbott-/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews .

1 Zoni-Berisso M, Lercari F, Carazza T, Domenicucci S. Epidemiology of atrial fibrillation: European perspective. Clin Epidemiol . 2014;6:213-220. Published 2014 Jun 16. doi:10.2147/CLEP.S47385

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Abbott Announces New Partnerships and Programs to Advance its Diversity in Clinical Trials Initiative

Abbott Announces New Partnerships and Programs to Advance its Diversity in Clinical Trials Initiative

  • New efforts focus on research infrastructure, continued training of diverse clinical research personnel and improved diversity within Abbott's own clinical trials
  • Abbott's Diversity in Clinical Trials initiative aligns with the company's continued focus for greater health equity, expanded access, affordability and removing barriers to life-saving technology and innovation
  • The new programs build on a successful first year of the multi-million-dollar corporate initiative

Abbott (NYSE: ABT) today announced a series of new programs within its multi-million-dollar initiative to increase diversity in clinical trials and improve care among under-represented populations. The new additions to Abbott's Diversity in Clinical Trials initiative build on the partnerships, scholarships, and the focus on diversified participants in the company's own clinical trials during the initiative's first year.

The latest programs include the launch of a new initiative with the Norton Healthcare Foundation to build and implement new models of sustainable clinical research alongside the Institute for Health Equity, a Part of Norton Healthcare in Louisville, Ky. ; a new training program for clinical research coordinators in partnership with Barnett International; and a newly-created Diversity in Research Office at Abbott focused on ensuring diverse representation in clinical trials.

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Enanta Pharmaceuticals Announces AbbVie’s Investigational Regimen of Glecaprevir/Pibrentasvir Shows High SVR Rates

Enanta Pharmaceuticals, Inc., (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced 98 percent (n=102/104) of chronic hepatitis C virus (HCV) infected patients with severe chronic kidney disease (CKD) achieved sustained virologic response following 12 weeks of treatment (SVR12) with AbbVie’s investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) in the primary intent-to-treat (ITT) analysis. In a modified intent-to-treat (mITT) analysis, SVR12 was achieved in 100 percent (n=102/102) of severe CKD patients. The mITT analysis excludes patients who did not achieve SVR for reasons other than virologic failure. These new data from the Phase 3 EXPEDITION-4 study, evaluating patients with chronic HCV infection across all major genotypes (GT1-6) and severe CKD, will be presented as a late-breaker today at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston.
The EXPEDITION-4 results are the latest to be released from
registrational studies in AbbVie’s G/P clinical development program,
designed to investigate a faster path to virologic cure* for all major
HCV genotypes (GT1-6) and with the goal of addressing areas of continued
unmet need.
Glecaprevir (GLE), an NS3/4A protease inhibitor, is Enanta’s second
protease inhibitor being developed through its collaboration with
AbbVie. G/P is a once-daily regimen that combines two distinct antiviral
agents. G/P is a fixed-dose combination of glecaprevir (300mg) and
pibrentasvir (120mg), an NS5A inhibitor, dosed once-daily as three oral
tablets.
HCV is common among people with severe CKD, reaching prevalence of up to
80 percent in some regions of the world.1 In the U.S., it is
estimated that over 500,000 people have both chronic HCV and CKD2.
Some chronic HCV infected patients with severe CKD, particularly those
with GT2 and GT3 HCV infection, currently don’t have access to
direct-acting antivirals (DAAs). The development of new, safe and
effective regimens to treat HCV in these patients remains a critical
unmet medical need.3
The EXPEDITION-4 study enrolled 104 patients with severe chronic kidney
disease, including 85 patients (82 percent) who were receiving dialysis
at enrollment and 20 patients (19 percent) who had compensated
cirrhosis. The study also included those who were not cured with
previous treatment with sofosbuvir (SOF) plus ribavirin (RBV) or with
interferon (IFN) plus RBV, with or without SOF (44 patients, 42 percent).
The majority of treatment related adverse events (AEs) were mild or
moderate. The most commonly reported AEs included pruritus, fatigue and
nausea. Of the 24 percent of patients who experienced serious AEs, none
were considered related to G/P. Four AEs (4 percent) led to the
discontinuation of G/P and one patient died after achieving SVR4
due to a serious AE (intracerebral hemorrhage) considered not-related to
G/P.
*Patients who achieve a sustained virologic response at 12 weeks post
treatment (SVR
12) are considered cured of
hepatitis C

About the EXPEDITION-4 Study
EXPEDITION-4 is a single-arm,
open-label, Phase 3 study evaluating the safety and efficacy of 12 weeks
of G/P in patients with GT1-6 chronic HCV infection and chronic kidney
disease, including those on dialysis. The primary endpoint is SVR12.
Patients in the study had severe or end stage kidney disease (stage 4
and 5 CKD), with an eGFR < 30 mL/min/1.73 m2 required at screening.
Prior treatment in the study is defined as treatment with interferon
(IFN)/pegIFN ± RBV, or sofosbuvir (SOF) + RBV ± pegIFN therapy.
Additional information on the clinical trials for G/P is available at www.clinicaltrials.gov/.
About Enanta
Enanta Pharmaceuticals is a research and
development-focused biotechnology company that uses its robust
chemistry-driven approach and drug discovery capabilities to create
small molecule drugs for viral infections and liver diseases. Enanta’s
research and development efforts are currently focused on four disease
targets: Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), Non-alcoholic
Steatohepatitis (NASH) and Respiratory Syncytial Virus (RSV).
Enanta has discovered novel protease inhibitors that are members of the
direct-acting-antiviral (DAA) inhibitor classes designed for use against
the hepatitis C virus (HCV). These protease inhibitors, developed
through Enanta’s collaboration with AbbVie, include paritaprevir, which
is contained in AbbVie’s marketed DAA regimens for HCV, and glecaprevir
(ABT-493), Enanta’s second protease inhibitor product, which AbbVie has
developed in Phase 3 studies in a fixed-dose combination (G/P) with
pibrentasvir (ABT-530), AbbVie’s second NS5A inhibitor, and is preparing
for regulatory approval filings in the U.S., Europe and Japan.
Enanta has also discovered EDP-305, an FXR agonist product candidate for
NASH, currently in Phase 1 clinical development, as well as a
cyclophilin inhibitor, EDP-494, a novel host-targeting mechanism for
HCV, which is also in Phase 1 clinical development. In addition, Enanta
has early lead candidates for HBV and RSV in preclinical development.
Please visit www.enanta.com
for more information on Enanta’s programs and pipeline.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements, including
statements with respect to the prospects for AbbVie’s investigational
HCV treatment regimen containing glecaprevir (ABT-493). Statements that
are not historical facts are based on management’s current expectations,
estimates, forecasts and projections about Enanta’s business and the
industry in which it operates and management’s beliefs and assumptions.
The statements contained in this release are not guarantees of future
performance and involve certain risks, uncertainties and assumptions,
which are difficult to predict. Therefore, actual outcomes and results
may differ materially from what is expressed in such forward-looking
statements. Important factors and risks that may affect actual results
include: the efforts of AbbVie (our collaborator developing glecaprevir)
to develop its glecaprevir/pibrentasvir(G/P) combination and
successfully obtain regulatory approval and commercialize it; the
regulatory and marketing efforts of others with respect to competitive
treatment regimens for HCV; regulatory and reimbursement actions
affecting G/P, any competitive regimen, or both; the need to obtain and
maintain patent protection for glecaprevir and avoid potential
infringement of the intellectual property rights of others; and other
risk factors described or referred to in “Risk Factors” in Enanta’s most
recent Form 10-K for the fiscal year ended September 30, 2015 and other
periodic reports filed more recently with the Securities and Exchange
Commission. Enanta cautions investors not to place undue reliance on the
forward-looking statements contained in this release. These statements
speak only as of the date of this release, and Enanta undertakes no
obligation to update or revise these statements, except as may be
required by law.
________________________________________________
1 Fabrizi F, Poordad FF, Martin P. Hepatitis C infection in
the patient with end stage renal disease. Hepatology. 2002;36(1):3-10.
2 IMS Health, July 2016. Parsippany, NJ; Medivo, July 2016.
New York, NY (Estimate based on IMS Health Dx Medical Claims
12/2013-4/2016; IMS Health Life Link Patient Level Data 12/2013-4/2016;
Medivo Lab Data 12/2013-4/2016).
3 American Association for the Study of Liver Diseases.
Recommendations for Testing, Managing, and Treating Hepatitis C,
February 24, 2016, https://www.hcvguidelines.org/full-report/monitoring-patients-who-are-starting-hepatitis-c-treatment-are-treatment-or-have.
Accessed March 15, 2016.

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Webcast   : www.knighttx.com or Webcast
This is a listen-only audio webcast. Media Player is required to listen to the broadcast.
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