SAN FRANCISCO, Sept. 30, 2019 (GLOBE NEWSWIRE) -- Eidos Therapeutics, Inc. (Eidos) (Nasdaq:EIDX), a clinical stage biopharmaceutical company focused on addressing the large and growing unmet need in transthyretin (TTR) amyloidosis (ATTR), today announced that an interim analysis of its ongoing Phase 2 open-label extension (OLE) study of AG10 in subjects with symptomatic ATTR cardiomyopathy will be presented in a late-breaking featured science oral presentation at this years American Heart Association (AHA) Scientific Sessions.
Daniel Judge, M.D., professor in the division of cardiology at the Medical University of South Carolina, will discuss the data in a presentation entitled Long-term Safety and Efficacy of AG10 in Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM): Interim Analysis of the Ongoing Phase 2 Open-Label Extension Study at 5:30 PM ET on November 16, 2019 as part of the Early Phase Science oral session.
In addition, Eidos will present several posters atAHA. The following summarizes Eidos presentations at the conference:
About AG10
AG10 is an investigational, orally-administered small molecule designed to potently stabilize tetrameric transthyretin, or TTR, thereby halting at its outset the series of molecular events that give rise to TTR amyloidosis, or ATTR. In a Phase 2 clinical trial in patients with symptomatic ATTR-CM, AG10 was generally well tolerated, demonstrated greater than 90 percent average TTR stabilization at Day 28, and increased serum TTR concentrations, a prognostic indicator of survival in a retrospective study of ATTR-CM patients, in a dose-dependent manner.
AG10 was designed to mimic a naturally-occurring variant of the TTR gene (T119M) that is considered a rescue mutation because co-inheritance has been shown to prevent or ameliorate ATTR in individuals also inheriting a pathogenic, or disease-causing, mutation in the TTR gene. To our knowledge, AG10 is the only TTR stabilizer in development that has been observed to mimic the stabilizing structure of this rescue mutation.
The Phase 3 ATTRibute-CM study of AG10 in patients with ATTR-CM is underway. Part A of the study will assess the change from baseline in 6-minute walk distance (6MWD) at 12 months. Part B of the study will evaluate reduction in all-cause mortality and frequency of cardiovascular-related hospitalizations at 30 months. In addition, Eidos plans to initiate a Phase 3 study of AG10 in ATTR polyneuropathy (ATTR-PN) by the end of 2019.
About transthyretin amyloidosis (ATTR)
There is significant medical need in transthyretin amyloidosis (ATTR) given the large patient population and limited current standard of care. ATTR is caused by the destabilization of TTR due to inherited mutations or aging and is commonly divided into three distinct categories: wild-type ATTR cardiomyopathy (ATTRwt-CM), mutant ATTR cardiomyopathy (ATTRm-CM), and ATTR polyneuropathy (ATTR-PN). The worldwide prevalence of each disease is approximately 400,000 patients, 40,000 patients and 10,000 patients, respectively.
All three forms of ATTR are progressive and fatal. For patients with untreated ATTRwt-CM and ATTRm-CM, symptoms usually manifest later in life (age 50+), with median survival of three to five years from diagnosis. ATTR-PN either presents in a patient's early 30s or later (age 50+), and results in a median life expectancy of five to ten years from diagnosis for untreated patients. Progression of all forms of ATTR causes significant morbidity, impacts productivity and quality of life, and creates a significant economic burden due to the costs associated with progressively greater patient needs for supportive care.
About Eidos Therapeutics
Eidos is a BridgeBio Pharma subsidiary focused on addressing the large and growing unmet need caused by transthyretin (TTR) amyloidosis (ATTR). Eidos is developing AG10, a potentially disease-modifying therapy for the treatment of ATTR. For more information, please visit http://www.eidostx.com.
Forward-Looking Statements
This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act. All statements other than statements of historical facts, including the statements about the potential therapeutic and clinical benefits of AG10, the potential for AG10 to be a safe and effective treatment for all forms of ATTR-CM, the potential registrational endpoints in the ATTRibute-CM trial, our ability to enroll patients in and conduct the ATTRibute-CM trial and our planned Phase 3 clinical trial of AG10 in ATTR-PN in accordance with our plans, the timing of these events, the indications we intend to pursue and our possible clinical or other business strategies, are forward-looking statements. Forward-looking statements can be identified by terms such as believes, expects, plans, potential, would or similar expressions and the negative of those terms. These forward-looking statements are based on our managements current beliefs and assumptions about future events and on information currently available to management. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, risks and uncertainties related to: our limited operating history and historical losses, our liquidity to fund the development of AG10 through current and future milestones, our ability to raise additional funding to complete the development of AG10, our dependence on the success of AG10, our ability to enroll patients in the ATTRibute-CM trial and our planned Phase 3 clinical trial of AG10 in ATTR-PN, results from our clinical trials andpre-clinicalstudies and those of third parties working in the same area as our product candidate, our ability to advance AG10 in clinical development in accordance with our plans, and our dependence on third parties in connection with our manufacturing, clinical trials andpre-clinicalstudies. Additional risks and uncertainties that could affect our future results are included in the section titled Risk Factors and Managements Discussion and Analysis of Financial Condition and Results of Operations in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, which is available on the SECs website atwww.sec.govand our website at eidostx.com. Additional information on potential risks will be made available in other filings that we make from time to time with the SEC. In addition, any forward-looking statements contained in this press release are based on assumptions that we believe to be reasonable as of this date. Except as required by law, we assume no obligation to update these forward-looking statements, or to update the reasons if actual results differ materially from those anticipated in the forward-looking statements.
Media Contact:Carolyn Hawley Canale Communications619-849-5382Carolyn@canalecomm.com
Investor Contact:John GrimaldiBurns McClellan212-213-0006jgrimaldi@burnsmc.com
Follow this link:
- Best 30 Cardiology in Secaucus, NJ with Reviews - YP.com - April 12th, 2018 [April 12th, 2018]
- Cardiology | Weill Cornell Medicine - April 14th, 2018 [April 14th, 2018]
- Cardiology Conferences 2018 | Cardiology Meetings 2018 ... - April 26th, 2018 [April 26th, 2018]
- Dr. Anil Goel, MD - Birmingham, MI - Cardiology & Clinical ... - April 26th, 2018 [April 26th, 2018]
- Clinical Physiology (Cardiology) MSc/PGDip | Middlesex ... - May 15th, 2018 [May 15th, 2018]
- Cardiology Conferences 2018 | Upcoming Cardiology ... - May 16th, 2018 [May 16th, 2018]
- Clinical Cardiology Section | Cleveland Clinic - May 27th, 2018 [May 27th, 2018]
- Journal of Clinical and Experimental Cardiology - Open ... - June 6th, 2018 [June 6th, 2018]
- Cardiology Summit 2018 | Cardiology Conferences | Heart ... - June 23rd, 2018 [June 23rd, 2018]
- Cardiology Clinical and Research Faculty Members ... - June 26th, 2018 [June 26th, 2018]
- Cardiology Conferences 2018 | Cardiology Congress 2018 ... - June 26th, 2018 [June 26th, 2018]
- About Us - New Jersey Cardiology Associates - July 8th, 2018 [July 8th, 2018]
- About Us - Ventura Clinical Trials - August 16th, 2018 [August 16th, 2018]
- Clinical Cardiology Made Ridiculously Simple: Michael A ... - August 22nd, 2018 [August 22nd, 2018]
- Clinical Cardiology - American Society of Preventive Cardiology - October 2nd, 2018 [October 2nd, 2018]
- Heart Surgery Hospital in india | Cardiology Treatment ... - October 7th, 2018 [October 7th, 2018]
- Clinical Cardiology - American Society of Preventive ... - December 3rd, 2018 [December 3rd, 2018]
- Guideline Clinical App - American College of Cardiology - December 7th, 2018 [December 7th, 2018]
- Journal of Clinical and Experimental Cardiology- Open ... - December 12th, 2018 [December 12th, 2018]
- Clinical Cardiology - Baptist Health - December 30th, 2018 [December 30th, 2018]
- Cardiology at Cancun: Topics in Clinical Cardiology - February 5th, 2019 [February 5th, 2019]
- Department of Cardiovascular Medicine, KU School of Medicine - March 10th, 2019 [March 10th, 2019]
- Towards Health Equality: Improving the Management of Cardiovascular Diseases in Women - International Atomic Energy Agency - September 21st, 2019 [September 21st, 2019]
- Lifetime Risk of PAD Varies by Race, but All Are Vulnerable to Traditional Risk Factors - TCTMD - September 21st, 2019 [September 21st, 2019]
- DEFINE-HF: Dapagliflozin Improves Function and QoL, but Not Biomarkers, in HFrEF - TCTMD - September 21st, 2019 [September 21st, 2019]
- Combining Nature and Technology, Luye Medical and Cleveland Clinic Join to Build a Future Hospital in Shanghai - Yahoo Finance - September 21st, 2019 [September 21st, 2019]
- Will Renal Denervation for Hypertension Rise Again? - Medscape - September 21st, 2019 [September 21st, 2019]
- Obstructive Sleep Apnea, Sleep Symptoms, and their Association with Cardiovascular Disease - DocWire News - September 21st, 2019 [September 21st, 2019]
- CNE expands pulmonary, sleep services with Brigham & Women's physicians - Warwick Beacon - September 21st, 2019 [September 21st, 2019]
- What I Am Most Looking Forward to at TCT 2019 - TCTMD - September 21st, 2019 [September 21st, 2019]
- Serelaxin Not Linked to CV Mortality Reduction in Patients Hospitalized for Acute HF - The Cardiology Advisor - September 21st, 2019 [September 21st, 2019]
- Sacubitril-Valsartan Not Linked to Lower Hospitalization Risk, CV Death in HFpEF - The Cardiology Advisor - September 21st, 2019 [September 21st, 2019]
- FDA clears multiuse angiography systems from Siemens Healthineers - DOTmed HealthCare Business News - September 21st, 2019 [September 21st, 2019]
- Balloon Pulmonary Angioplasty Effective for Chronic Thromboembolic PH - The Cardiology Advisor - September 21st, 2019 [September 21st, 2019]
- RWJBarnabas Health, St. Luke's University Health launch clinical affiliation - FierceHealthcare - September 21st, 2019 [September 21st, 2019]
- Bilirubin: A Novel Indicator of Infective Endocarditis Adverse Outcomes - The Cardiology Advisor - September 21st, 2019 [September 21st, 2019]
- Major Bleeding Mostly Early, Not Severe With Rivaroxaban Plus Aspirin in COMPASS - TCTMD - September 21st, 2019 [September 21st, 2019]
- Community-based Care Model Reduces CVD Risk - Managed Healthcare Executive - September 21st, 2019 [September 21st, 2019]
- American College of Cardiology Steps Up: Equal Pay, Opportunities for All - TCTMD - September 21st, 2019 [September 21st, 2019]
- FDA Approves Novo Nordisk's Oral Semaglutide, First GLP-1 in Pill Form - AJMC.com Managed Markets Network - September 21st, 2019 [September 21st, 2019]
- A New Drug for HF? DEFINE-HF Bolsters Dapagliflozin Cardio Cred - Medscape - September 21st, 2019 [September 21st, 2019]
- Seeking Synergy: Bringing Cardiology into Your Enterprise Imaging Strategy - Health Imaging - September 21st, 2019 [September 21st, 2019]
- TCT 2019 Day Two: Transcatheter Valves, New and Old - TCTMD - September 30th, 2019 [September 30th, 2019]
- Transcatheter Options Best for Tricuspid Regurgitation in Matched Registry Analysis - TCTMD - September 30th, 2019 [September 30th, 2019]
- Bypass Surgery and Coronary Stenting Yield Comparable 10-Year Survival - Diagnostic and Interventional Cardiology - September 30th, 2019 [September 30th, 2019]
- TAVR Improves Health Status Over Surgery in Low-Risk Patients at 1 Year: PARTNER 3 - TCTMD - September 30th, 2019 [September 30th, 2019]
- Off Script: The New Gatekeepers of Procedural Education - TCTMD - September 30th, 2019 [September 30th, 2019]
- Study Shows Safety and Efficacy of Near Infrared Spectroscopy (NIRS) Imaging to Identify Patients and Plaques at an Increased Risk for MACE - BioSpace - September 30th, 2019 [September 30th, 2019]
- The Heart of the Matter: Cardiovascular Fitness in Horses - United States Eventing Association - September 30th, 2019 [September 30th, 2019]
- Google parent Alphabet hires former FDA head Robert Califf to lead health strategy and policy - FierceHealthcare - September 30th, 2019 [September 30th, 2019]
- Inclisiran Benefits Patients With Familial Hypercholesterolemia and ASCVD - The Cardiology Advisor - September 30th, 2019 [September 30th, 2019]
- AUGUSTUS: Best Benefit With Apixaban, P2Y12 Inhibitor Dual Therapy - Medscape - September 30th, 2019 [September 30th, 2019]
- New TAVR System Safe and Effective for High-Risk Surgical Patients with Severe Aortic Stenosis - Newswise - September 30th, 2019 [September 30th, 2019]
- Dapagliflozin Improves Heart Failure-Related Health Status in HFrEF - The Cardiology Advisor - September 30th, 2019 [September 30th, 2019]
- Remote Ischemic Conditioning Did Not Improve 12 Month Clinical Outcomes After STEMI - The Cardiology Advisor - September 30th, 2019 [September 30th, 2019]
- Insights from the European Society of Cardiology congress | Speaking of Medicine - PLoS Blogs - September 30th, 2019 [September 30th, 2019]
- Smokers Have More Pulmonary Emboli, Leading to Higher Hospital Readmission Rates | - Diagnostic and Interventional Cardiology - October 22nd, 2019 [October 22nd, 2019]
- AZ's Farxiga gets heart failure prevention okay from FDA - PMLiVE - October 22nd, 2019 [October 22nd, 2019]
- Bayer Announces Recipients of the Pulmonary Hypertension Accelerated Bayer (PHAB) Awards at CHEST Annual Meeting 2019 - BioSpace - October 22nd, 2019 [October 22nd, 2019]
- The Epidemic Of The Metabolic Syndrome Among The Palestinians In The G | DMSO - Dove Medical Press - October 22nd, 2019 [October 22nd, 2019]
- Optina Diagnostics and the Montreal Heart Institute Partner to Develop a New Biomarker for Atherosclerosis - PRNewswire - October 22nd, 2019 [October 22nd, 2019]
- Even With Same Diagnosis, Women Get Half the Heart Attack Treatments as Men - AJMC.com Managed Markets Network - October 22nd, 2019 [October 22nd, 2019]
- Eva Dickerman, Andrew Weil - The New York Times - October 22nd, 2019 [October 22nd, 2019]
- EHR vendor Veradigm and partners creating new shared data tools for researchers - Healthcare IT News - October 22nd, 2019 [October 22nd, 2019]
- Evolocumab Well-tolerated as Add-on for Hypercholesterolemia Therapy - DocWire News - October 22nd, 2019 [October 22nd, 2019]
- Deborah Heart and Lung Center announces affiliation with Cleveland Clinic Heart & Vascular Institute - Health Essentials from Cleveland Clinic - October 22nd, 2019 [October 22nd, 2019]
- New Registry to Provide Insight into STEMI Occurrence, Treatment in North India | - Diagnostic and Interventional Cardiology - October 22nd, 2019 [October 22nd, 2019]
- Finding Your Best Fit in Cardiology - TCTMD - October 22nd, 2019 [October 22nd, 2019]
- Cardiology team expands to meet community need - The Union of Grass Valley - October 22nd, 2019 [October 22nd, 2019]
- Deaths After Ablation of Atrial Fibrillation 'Concerning' in Real-World Analysis - TCTMD - November 1st, 2019 [November 1st, 2019]
- Cutler Family gifts $15 million to University Hospitals to transform mens health care - Newswise - November 1st, 2019 [November 1st, 2019]
- Troponin Increases After Elective PCI Tied to Complexity, Extent of CAD - TCTMD - November 1st, 2019 [November 1st, 2019]
- Caregiving and the Soul of Medicine - Medscape - November 1st, 2019 [November 1st, 2019]
- STEMI Mortality Unaffected by Weekend, Weeknight, or Holiday Admission in France - TCTMD - November 1st, 2019 [November 1st, 2019]
- Cardiva Medical publishes positive results from the AMBULATE pivotal study Cardiology2.0 - Cardiology2.0 - November 1st, 2019 [November 1st, 2019]
- Gaps in Access to TAVR and SAVR: 'Something Needs to Be Done' - TCTMD - November 1st, 2019 [November 1st, 2019]
- Cardiva Medical Announces Publication of Data From the AMBULATE Pivotal Study in the Journal of the American College of Cardiology: Clinical... - November 1st, 2019 [November 1st, 2019]
- Raymond James 4 Analyst Favorite Health Care Picks With Huge Upside Potential - 24/7 Wall St. - November 7th, 2019 [November 7th, 2019]
- Global Computed Tomography (CT) Scanners Devices and Equipment Market Report 2020: Major Players are GE Healthcare, Koninklijke Philips, Hitachi,... - November 7th, 2019 [November 7th, 2019]
- Vasospasm, Microvascular Dysfunction Tied to MACE in Nonobstructive CAD - TCTMD - November 7th, 2019 [November 7th, 2019]