Senile cardiac amyloidosis

Phase 3 – REVEAL study for iodine 124I-evuzamitide (AT-01) in patients with suspected cardiac amyloidosis has begun enrollment by Brigham and Women’s Hospital, Boston MA, in conjunction with Attralus. Attralus is developing 124I-evuzamitide as the first non-invasive pan-amyloid PET imaging agent specifically designed for the diagnosis and management of patients with all types of systemic amyloidosis. Cardiac amyloidosis is underdiagnosed and there remains a significant unmet need for a more sensitive and specific imaging test that can diagnose patients earlier in the disease process. 124I-evuzamitide has received Breakthrough Therapy Designation from the Food and Drug Administration (FDA) for PET imaging in patients with suspected or known cardiac amyloidosis. 124I-evuzamitide has been granted orphan drug designations as a diagnostic for the management of ATTR and AL amyloidosis by both the US FDA and the European Commission. Enrollment is expected to be completed by the end of 2025. Naples, FL – January 15, 2024 – Attralus, Inc., a clinical stage biopharmaceutical company developing transformative products to improve the lives of patients with systemic amyloidosis, and Brigham and Women’s Hospital, Boston, MA, are pleased to announce the enrollment of the first patient in the Research with 124I-EVuzamitide to Elucidate Cardiac AmyLoidosis (REVEAL) study – A Phase 3 clinical trial of the investigational diagnostic imaging agent, 124I-evuzamitide (AT-01), in patients with suspected cardiac amyloidosis. The trial is designed to determine the sensitivity and specificity of 124I-evuzamitide imaging to diagnose cardiac amyloidosis. “This study seeks to add significant value for patient care,” says Dr. Sharmila Dorbala, Principal Investigator and Sponsor of the REVEAL study. “124I-evuzamitide PET/CT imaging offers an exciting opportunity to noninvasively detect various types of amyloid deposition in the heart and other organs. As cardiac amyloidosis has high morbidity and mortality, early diagnosis is crucial. With effective FDA-approved treatments now available, a scan that can definitively detect amyloidosis or exclude it would be a major step forward to reduce diagnostic delays and improve patient outcomes.” 124I-evuzamitide has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for positron emission tomography (PET) imaging in patients with suspected or known cardiac amyloidosis. FDA granted BTD for 124I-evuzamitide based on clinical data from Attralus-sponsored and investigator-initiated studies evaluating the use of 124I-evuzamitide in patients with systemic amyloidosis, representing experience in more than 200 trial participants. It is one of the first investigational diagnostic imaging agents to receive BTD from the FDA, and the only diagnostic imaging agent that has received BTD for cardiac amyloidosis. Additionally, Orphan Drug Designations have been granted to 124I-evuzamitide as a diagnostic for the management of ATTR and AL amyloidosis by both the US FDA and the European Commission. “There are no FDA-approved diagnostic imaging agents for cardiac amyloidosis. The diagnosis of cardiac amyloidosis can be a challenging and time-consuming process for patients, with many going years without an accurate diagnosis, and losing critical time in the process”, said Spencer Guthrie, Chief Operating Officer, Attralus. “Early diagnosis in this disease leads to better patient outcomes. We remain committed to bringing 124I-evuzamitide to the market as quickly as possible and look forward to working closely with the FDA and Dr. Dorbala to bring 124I-evuzamitide to patients.” About REVEAL study The study will enroll up to 200 participants with suspected cardiac amyloidosis in the United States. Cardiac amyloidosis may include ATTR, AL or other types of cardiac amyloidosis such as ApoA1 or ApoA4. The primary objective is to evaluate the efficacy of 124I-evuzamitide for diagnosing cardiac amyloidosis. The co-primary endpoints are 1) To determine the sensitivity of PET/CT imaging with 124I-evuzamitide for the diagnosis of cardiac amyloidosis based on visual scan interpretation by independent PET readers and 2) To determine the specificity of PET/CT imaging with 124I-evuzamitide for the diagnosis of cardiac amyloidosis based on visual scan interpretation by independent PET readers. The secondary objective is to evaluate the safety of a single intravenous administration of 124I-evuzamitide. There are a number of exploratory objectives including, but not limited to, evaluating the ability to 124I-evuzamitide to detect extracardiac organ involvement and to differentiate AL from ATTR amyloidosis. Additional information about the REVEAL trial will be posted to clinicaltrials.gov. About 124I-evuzamitide (AT-01) Pan-Amyloid Diagnostic 124I-evuzamitide is the first non-invasive pan-amyloid PET imaging agent specifically designed for systemic amyloidosis. 124I-evuzamitide utilizes the company’s pan-amyloid binding peptide labeled with iodine-124 as an amyloid-specific radiotracer to detect all types of systemic amyloidosis by PET/CT imaging. In clinical trials, 124I-evuzamitide has been observed to detect multiple types of amyloid deposits, including ATTR and AL, in major organs such as the heart, kidney, liver, and spleen. Orphan drug designations have been granted to 124I-evuzamitide as a diagnostic for the management of ATTR and AL amyloidosis by both the Food and Drug Administration (FDA) and the European Commission. About Systemic Amyloidosis Systemic amyloidosis encompasses a diverse group of rare diseases that occur due to accumulation of toxic amyloid deposits in tissues and organs, a consequence of aberrant protein misfolding events. These diseases are progressive, debilitating and often fatal. The majority of systemic amyloidosis patients have cardiac involvement, including the two most common forms, with ~95% of ATTR and 75% of AL patients having cardiac involvement. Other rare types of systemic amyloidosis such as AA, AApoAI, AApoAIV also have cardiac involvement. Cardiac amyloidosis is significantly underdiagnosed due to low awareness, non- specific symptoms, and lack of disease-specific diagnostics. There remains a significant unmet need for better diagnostics that may be able to more accurately diagnose patients earlier in the disease process. About Attralus Attralus is a clinical stage biopharmaceutical company focused on creating transformative medicines and diagnostics to improve the lives of patients with systemic amyloidosis. The company’s proprietary pan-amyloid removal (PAR) therapeutics are designed to directly bind to and remove toxic amyloid in organs and tissues. By targeting the disease-causing pathology in systemic amyloidosis diseases, PAR therapeutics have the potential to treat and reverse disease in patients with all types and stages of systemic amyloidosis. Attralus was founded by scientific experts in the field of amyloidosis and the company is headquartered in Naples, FL. Forward-Looking Statements This press release contains forward-looking statements, including statements related to the efficacy, continued development, and potential of AT-01. Words such as “developing,” “potential,” “shown” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Attralus’ current expectations. Forward-looking statements involve risks and uncertainties. Attralus’ actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. Attralus expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Attralus’ expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based. Contact: Krishna Gorti, M.D. FRCSCorporate Developmentkgorti@attralus.com

With last week's FDA approval of Attruby (acoramidis), BridgeBio may reach transthyretin amyloid cardiomyopathy (ATTR-CM) patients first, but Alnylam isn't far behind. The company used a priority review voucher as part of its regulatory submission for RNAi therapeutic vutrisiran, which the US regulator accepted on Monday and granted a PDUFA date of March 23, 2025. BridgeBio and Alnylam are both vying for a piece of the ATTR-CM market, which Pfizer currently dominates. The pharma's tafamidis — marketed as Vyndamax and Vyndaqel — became the first drug approved for the rare heart disease in 2019, and last year brought in a total of $3.3 billion in global sales. While BridgeBio's Attruby, an oral TTR stabiliser, has the same mechanism of action as tafamidis, Alnylam's asset is a wholly separate modality. Vutrisiran is designed to deliver rapid knockdown of mutant and wild-type transthyretin (TTR), the disease's underlying cause. The RNAi therapeutic was approved in 2022 as Amvuttra to treat polyneuropathy in adults with hereditary transthyretin-mediated (hATTR) amyloidosis.ATTR anticipationCardiologists have been excited about vutrisiran's potential in ATTR-CM since Alnylam top-lined data from the Phase III HELIOS-B trial in June.  In the overall study population, vutrisiran reduced all-cause mortality and recurrent cardiovascular events by 28% compared to placebo (see – Physician Views Results: Cardiologist feedback suggests Alnylam well placed to take on Pfizer in ATTR-CM field).Further results from HELIOS-B shared in August at the European Society of Cardiology (ESC) congress demonstrated that in the overall study population, vutrisiran reduced the relative risk of death by 31% through month 36, and by 36% after up to 42 months. However, patients not receiving tafamidis at the trial's start saw a non-significant risk reduction of 30% at 36 months. After the data drop, FirstWord spoke with Sarju Ganatra, director of the Cardio-Oncology Programme and co-director of the South Asian Cardio-Metabolic Programme at Lahey Hospital and Medical Center, who said the monotherapy arm showed a "lacklustre performance on the mortality benefit." For the full interview, see KOL Views Q&A: HELIOS-B cements pecking order for Alnylam’s Amvuttra, Pfizer’s Vyndamax in ATTR-CM.A pair of physician polls conducted after the ESC presentation showed that vutrisiran is on track to become an important new treatment option for ATTR-CM, though the majority of cardiologists noted that it was likely to be used most frequently alongside other treatment options (see Physician Views Poll Results: Amvuttra another compelling treatment option for ATTR-CM, say majority of cardiologists and Physician Views Results: Cardiologists have much to ponder with ATTR-CM treatment options set to expand).Meanwhile, Alnylam also has next-generation siRNA therapeutic nucresiran in early-stage testing for ATTR. The drug recently demonstrated rapid and durable reduction of serum TTR in healthy participants.

CAMBRIDGE, Mass.--( BUSINESS WIRE )-- Anumana , a leading AI-driven health technology company, has been named to Fast Company’s 2024 Next Big Things in Tech list in the Health category. This distinction highlights Anumana’s work leveraging artificial intelligence (AI) to transform routine electrocardiograms (ECG) into tools that enable earlier diagnosis and treatment. “We’re honored to be recognized by Fast Company for our work in advancing cardiovascular care through our ECG-AI algorithms,” said Maulik Nanavaty, CEO of Anumana. “This award reflects our leadership in developing evidence-based AI algorithms that empower physicians to detect diseases and intervene earlier. We believe that innovation like our ECG-AI low ejection fraction algorithm, trained, validated, and studied across more than 150,000 patients, is changing the landscape of heart health and setting new standards for patient care.” Heart failure remains a leading cause of death and hospitalization globally, affecting nearly 6.7 million adults in the U.S. alone. Anumana’s FDA-cleared ECG-AI™ Low Ejection Fraction (LEF) algorithm uncovers insights from standard 12-lead ECG readings, enabling clinicians to diagnose and treat patients sooner. Currently available and recognized by the Centers for Medicare & Medicaid Services (CMS), the algorithm detects LEF—a key indicator of heart failure—without the onset of clear symptoms or conventionally identified ECG abnormalities. The company’s expansive pipeline includes dozens of first-in-class algorithms, including FDA Breakthrough Device-Designated ECG-AI algorithms for detecting pulmonary hypertension, cardiac amyloidosis, and hyperkalemia. Anumana plans to bring numerous algorithms to the market next year in the U.S. and Europe. “The Next Big Things in Tech provides a fascinating glimpse at near- and long-term technological breakthroughs across a variety of sectors,” said Brendan Vaughan, editor-in-chief of Fast Company. “Spanning everything from semiconductors to agricultural gene editing, the companies featured in this year’s list are tackling some of the world’s most pressing and vexing problems.” Fast Company’s Next Big Things in Tech highlights new technology breakthroughs that promise to help define the future of the industries they serve. This year, 138 technologies developed by established companies, startups, or research teams are featured for their potential to revolutionize the lives of consumers, businesses, and society overall. Click here to see the final list. About Anumana Anumana is a leading AI-driven health technology company leveraging cutting-edge AI and industry-leading translational science to unlock the electrical language of the heart as never before. The company was founded by nference in collaboration with Mayo Clinic to leverage the clinical and technical expertise of both organizations to develop innovative ECG-AI technology into a clinically meaningful, medical-grade, and easy-to-use tool for clinicians to advance patient care. Anumana’s software-as-a-medical device (SaMD) ECG-AI™ solutions aim to detect diseases earlier using standard-of-care ECG readings, enabling clinicians to enhance and improve care with real-time AI insights. Anumana’s award-winning lead algorithm, ECG-AI™ LEF, is now available in the U.S. To learn more about how the algorithm can help clinicians identify LEF earlier and schedule a demo, visit us at ECG-AI LEF . For more information, visit www.anumana.ai or follow us on LinkedIn and X . About Fast Company Fast Company is the only media brand fully dedicated to the vital intersection of business, innovation, and design, engaging the most influential leaders, companies, and thinkers on the future of business. The editor-in-chief is Brendan Vaughan. Headquartered in New York City, Fast Company is published by Mansueto Ventures LLC, along with our sister publication, Inc., and can be found online at fastcompany.com.