ACCESS Newswire

IRF Reputation AG

Share
Neurimmune: Promising Phase 1 Results for Antibody NI006 in ATTR Cardiomyopathy Published in the New England Journal of Medicine

Results also presented during late-breaking session at ESC Heart Failure congress 2023

ZURICH, SWITZERLAND / ACCESSWIRE / May 20, 2023 / Neurimmune announced today that primary results of its Phase 1 proof-of-concept study of NI006, a recombinant human antibody to deplete amyloid deposits in ATTR cardiomyopathy, have been presented in Prague at Heart Failure 2023, a scientific congress of the European Society of Cardiology (ESC), and published in The New England Journal of Medicine (DOI: 10.1056/NEJMoa2303765).

To view this piece of content from www.accesswire.com, please give your consent at the top of this page.



Amyloid transthyretin cardiomyopathy (ATTR-CM) is an underdiagnosed, systemic condition that leads to progressive heart failure and high rate of fatality within four years from diagnosis.1,2 Progressive ATTR amyloid depositions characterize the disease, causing heart failure and death. Despite recent advances and approved therapies, there remains significant unmet medical need in treating moderate to severe ATTR-CM, and amyloid depletion may constitute an important new mechanism to achieve further effectiveness.

NI006 has been designed to target the pathology of ATTR-CM by enabling depletion of amyloid fibrils in the heart. This Phase 1 study investigated safety, tolerability, pharmacology, and efficacy at 12 months of NI006 treatment in ascending doses.

Results indicate that the safety profile of NI006 is favorable up to the highest dose tested. No apparent dose-limiting toxic effects or drug-related serious adverse reactions were observed. The pharmacokinetic profile was consistent with that of an IgG antibody, and no antidrug antibodies were detected. At doses of at least 10 mg per kilogram, cardiac amyloid deposition (detected by either scintigraphy or cardiac magnetic resonance imaging) was substantially reduced over a period of 12 months. Reductions were also seen in levels of biomarkers measuring cardiac stress and cardiomyocyte death, N-terminal pro-B-type natriuretic peptide and troponin T.

"The depletion of the cardiac ATTR deposits is a rational therapeutic target to revert disease pathology and restore organ function", said Dr. Pablo Garcia-Pavia from the Hospital Universitario Puerta de Hierro and CNIC in Madrid, Spain, and principal investigator of the study. "The results of this study are very promising and show initial evidence that NI006 acts as a depleter of cardiac amyloid load with potential to improve cardiac structure, function and outcomes in ATTR cardiomyopathy."

"ATTR cardiomyopathy is a rare but serious condition that is progressive, systemic and potentially fatal," said Gianluca Pirozzi, SVP, Head of Development, Regulatory and Safety, Alexion. "These early results are encouraging, and we look forward to continuing to evaluate NI006 as a potential therapeutic option to address the high unmet medical need."

"We thank all patients, their families and investigators, study staff and collaborators for the participation in the NI006 first-in-human study," said Prof. Christoph Hock, Chief Medical Officer of Neurimmune. "The NI006 results warrant further development of this drug candidate with the potential of reverting disease progression in ATTR amyloidosis."

In 2022, Neurimmune entered into an exclusive global collaboration and license agreement with Alexion, AstraZeneca's Rare Disease group, for NI006. Neurimmune will continue to be responsible for completion of the current Phase 1 clinical trial on behalf of Alexion, and Alexion will pay certain trial costs. Following the Phase 1 trial, Alexion will be responsible for further clinical development, manufacturing, and commercialization.

1. Lauppe RE, et al. Nationwide prevalence and characteristics of transthyretin amyloid cardiomyopathy in Sweden. Open Heart. 2021 Oct;8(2):e001755. doi: 10.1136/openhrt-2021-001755.

2. González-Duarte A, et al. Impact of non-cardiac clinicopathologic characteristics on survival in transthyretin amyloid polyneuropathy. Neurol Ther. 2020;9(1):135-149. doi:10.1007/s40120-020-00183-7.

NI006 Published Article in The New England Journal of Medicine:

Phase 1 Trial of Antibody NI006 for Depletion of Cardiac Transthyretin Amyloid

Pablo Garcia-Pavia, MD PhD1; Fabian aus dem Siepen, MD2; Erwan Donal, MD PhD3; Olivier Lairez, MD4; Peter van der Meer, MD PhD5; Arnt V. Kristen, MD6; Michele F. Mercuri, MD PhD7; Aubin Michalon, PhD8; Robert J. A. Frost, MD PhD8; Jan Grimm, PhD8; Roger M. Nitsch, MD8,9; Christoph Hock, MD8,9; Peter C. Kahr, MD8,10; Thibaud Damy, MD PhD11.

N Engl J Med 2023; DOI: 10.1056/NEJMoa2303765

The authors' affiliations are as follows: 1) Hospital Universitario Puerta de Hierro Majadahonda, IDIPHISA, CIBERCV, Madrid, Spain, Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain, Universidad Francisco de Vitoria (UFV), Pozuelo de Alarcon, Spain 2) University Hospital Heidelberg, Department of Cardiology, Im Neuenheimer Feld 410, 69120 Heidelberg, Germany 3) Department of Cardiology, University of Rennes, CHU Rennes, INSERM, LTSI - UMR 1099, Rennes, France 4) CHU de Toulouse - Hôpital Rangueil, Service de Cardiologie, 1 Avenue du Pr. Jean Poulhès, 31059 Toulouse, France 5) Department of Cardiology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9713 GZ Groningen, The Netherlandsn 6) Cardiovascular Center Darmstadt, Dieburger Straße 31c, 64287 Darmstadt, Germany 7) Alexion/AstraZeneca Rare Disease, 121 Seaport Blvd, Boston, MA 02210, USA 8) Neurimmune AG, Wagistrasse 18, 8952 Schlieren, Switzerland 9) Institute for Regenerative Medicine, University of Zurich, Wagistrasse 13, 8952 Schlieren, Switzerland 10) Center for Molecular Cardiology, University of Zurich, Wagistrasse 13, 8952 Schlieren, Switzerland 11) Cardiology Department and French National Reference Centre for Cardiac Amyloidosis, at Hôpitaux Universitaires Henri Mondor, AP-HP, and IMRB, INSERM, Université Paris Est Creteil, 94010 Créteil, France.

www.neurimmune.com

Contact Information

Martin Meier-Pfister
Neurimmune Media Team
media@neurimmune.com

SOURCE: Neurimmune

To view this piece of content from stats.newswire.com, please give your consent at the top of this page.

View source version on accesswire.com:
https://www.accesswire.com/756225/Neurimmune-Promising-Phase-1-Results-for-Antibody-NI006-in-ATTR-Cardiomyopathy-Published-in-the-New-England-Journal-of-Medicine

To view this piece of content from www.accesswire.com, please give your consent at the top of this page.

About ACCESS Newswire

DK

Subscribe to releases from ACCESS Newswire

Subscribe to all the latest releases from ACCESS Newswire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from ACCESS Newswire

Air Quality Solutions Launches the UK's Most Advanced Software for Air Quality Assessments19.9.2025 08:00:00 CEST | Press release

New cloud-based app helps Air Quality Consultants deliver Air Quality Assessments for planning applications 80% faster. NOTTINGHAM, UK / ACCESS Newswire / September 19, 2025 / Air Quality Solutions announces the launch of its ground-breaking Air Quality Software. This game-changing app enables air quality consultants to reliably complete assessments 80% faster and with higher accuracy. It boosts team productivity and reduces delivery costs.Air Quality Software User Interface "Air Quality Software has set a new standard," said Brendan McCormack, Founder of Air Quality Solutions. "Air Quality Assessments are now faster, easier, and more reliable than ever before. This software reflects years of hard work and we are excited to bring it to market. " Air Quality Solutions unveils exactly how Air Quality Software has transformed air quality assessments for planning: 1. More accurate methods Traditionally, air quality consultants manually measure or estimate critical data points such as vehic

Conga Hosts Premier European Customer Conference "Conga Connection EMEA 2025" in Paris18.9.2025 10:00:00 CEST | Press release

Leading B2B SaaS Company to Host More Than 150 Customers and Partners at Flagship EMEA Event October 8 LONDON, UK / ACCESS Newswire / September 18, 2025 / Conga, the market leader in AI-powered innovation in configure, price, quote (CPQ) and contract lifecycle management (CLM), and Document Automation, will host its flagship European customer conference, Conga Connection EMEA 2025, taking place October 8, at the prestigious Pullman Paris Tour Eiffel. The event is expected to attract more than 150 customers, partners, and industry leaders from across Europe for a day of learning, innovation, and networking focused on advancing business transformation and operational excellence. The conference will feature keynote presentations from Conga's executive leadership, including CEO Dave Osborne who will share Conga's strategic vision for empowering organizations to accelerate their journey to become a more connected, intelligent business, better able to minimize risk and maximize revenue. Cong

Karbon-X Corp. Files Year-End Financial Results17.9.2025 14:00:00 CEST | Press release

CALGARY, AB / ACCESS Newswire / September 17, 2025 / Karbon-X Corp. (OTCQX:KARX) ("Karbon-X or the "Company"), a vertically integrated climate solutions company, today announced that it has filed its Form 10-K with audited financial results for the fiscal year ended May 31, 2025. The full filing is available under the Company's profile on OTC Markets at www.otcmarkets.com/stock/KARX/overview Operational and Strategic Highlights for Fiscal Year 2025 Completed the acquisition of ALLCOT Group, expanding Karbon-X's global footprint and integrating world-class expertise. Launched trading operations, marking a critical milestone in validating the Company's business model and initiating its revenue-generating activities. Entered landmark partnerships with major energy producers and with the BK Dukes, reflecting strong market confidence in Karbon-X's vision and capabilities. Financial Highlights for Fiscal Year 2025 Revenue surged to $3.16 million, up from $0.41 million in the prior year, mark

TruMerit Adds Two More Global Credentials for Rehabilitation Care Workers16.9.2025 20:00:00 CEST | Press release

PHILADELPHIA, PA / ACCESS Newswire / September 16, 2025 / TruMerit, a global leader in healthcare workforce development, today launched two new global credentials for healthcare workers specializing in rehabilitation, habilitation, and restorative care. The Certified Global Health Worker-Rehabilitation (CGHW-R) and the Certified Global Health Worker-Rehabilitation Advanced (CGHW-RA) have been developed specifically for eligible health workers worldwide who wish to have their applied experience and competencies in rehab care recognized and verified by passing a certification examination. These credentials, along with the Certified Global Nurse-Rehabilitation (CGN-R) that TruMerit established last year, are intended to advance and improve services for the more than two billion people worldwide who need this care. The CGHW-RA credential was developed for those with a degree or diploma in a rehabilitation field. These include clinicians, educators, and instructors with physiotherapy, occup

Second Blue Magic Netherlands Event Set for November 1816.9.2025 18:30:00 CEST | Press release

Registration Site Is Open and Dutch Innovators Are Encouraged to Attend and Apply to Present Capabilities SAN DIEGO, CALIFORNIA / ACCESS Newswire / September 16, 2025 / General Atomics Aeronautical Systems, Inc. (GA-ASI), in collaboration with the Dutch Ministry of Defence and the Dutch Ministry of Economic Affairs, will host its second Blue Magic Netherlands (BMNL) event on November 18, 2025. BMNL 2025 follows the successful first event in 2024 and will take place at the MELT at Avular building, a world-class venue for technology interchange near Brainport Eindhoven, the center of the Dutch high-technology manufacturing industry. The registration site can be accessed at www.ga-asi.com/blue-magic-netherlands-2025. "The first BMNL event was a huge success for Dutch industry," said Brad Lunn, managing director for GA-ASI. "We've built strong investment opportunities with Dutch companies - including Arceon, Emergent Swarm Solutions, and Saluqi Motors - and now we're looking to build on th

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye