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Lantheus Announces Collaboration to Provide Novel Tau Imaging Agent for Large Consortium Clinical Trial Sponsored by the National Institute on Aging

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Lantheus Holdings, Inc. announces a collaboration agreement with the Consortium for Clarity in ADRD Research Through Imaging (CLARiTI) to supply MK-6240, a clinical-stage F18-labeled PET imaging agent targeting tau tangles, for investigating Alzheimer's disease and related dementias. The study involves 37 Alzheimer's Disease Research Centers in the US, recruiting 2,000 subjects to generate etiologic profiles for cases of mixed dementia.
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The collaboration between Lantheus Holdings and the CLARiTI study represents a strategic initiative to enhance the diagnostic capabilities for Alzheimer's disease and related dementias. The use of MK-6240, an investigational PET imaging agent, is significant due to its potential to detect neurofibrillary tangles, a key pathological feature of Alzheimer's. This could lead to earlier and more accurate diagnosis, which is crucial in managing the disease and developing effective treatments.

From a research perspective, the involvement of all 37 Alzheimer’s Disease Research Centers and the recruitment of 2,000 subjects provides a robust dataset that could yield comprehensive etiologic profiles. This large-scale, multi-center approach may set a new precedent in the field of dementia research, potentially leading to breakthroughs in understanding the complex interplay of pathologies in dementia.

The partnership has the potential to position Lantheus as a frontrunner in the neuroimaging agents market, particularly for tau PET imaging. The successful implementation and results of the CLARiTI study could enhance the company's reputation and credibility in the radiopharmaceutical sector. This could, in turn, impact Lantheus' market share and stock performance positively, especially if MK-6240 advances towards regulatory approval and commercialization.

Investors and stakeholders should monitor the progress of the CLARiTI study closely, as positive outcomes may lead to increased interest in Lantheus' portfolio of imaging agents, potentially driving up demand and revenue. Conversely, any setbacks in the study could pose risks to the anticipated growth trajectory of the company.

The biotech industry, particularly companies focused on neurodegenerative diseases, will be closely monitoring the outcomes of the CLARiTI study. The results could have far-reaching implications for the development of new therapeutic agents targeting tau pathology. A successful imaging agent like MK-6240 could catalyze a wave of innovation in drug development for Alzheimer's, as it provides a tool to measure the efficacy of treatments targeting tau tangles.

Furthermore, the collaboration showcases a growing trend in the industry: partnerships between biotech companies and research institutions to leverage cutting-edge technologies for disease diagnosis and treatment. Such collaborations are essential for advancing the field and may encourage similar initiatives, fostering a more collaborative ecosystem within the biotech sector.

Lantheus to supply MK-6240, an investigational F18-labeled PET imaging agent that targets tau tangles

BEDFORD, Mass., Feb. 13, 2024 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today announced a collaboration agreement with a National Institute on Aging (NIA)-sponsored study called the Consortium for Clarity in ADRD Research Through Imaging (CLARiTI). This agreement enables the consortium to use MK-6240, Lantheus’ clinical-stage F18-labeled Positron Emission Tomography (PET) imaging agent, in its investigation of Alzheimer’s disease and related dementias. MK-6240 targets aggregated tau protein in the form of neurofibrillary tangles (NFTs) which are a hallmark of several neurodegenerative diseases, including Alzheimer’s disease.

The CLARiTI study will involve all 37 Alzheimer’s Disease Research Centers in the United States which will recruit 2,000 subjects and collect their imaging and blood-based biomarker data to generate etiologic profiles for cases of mixed dementia.

“This study is designed to shed light on the complex interplay of multiple pathologies contributing to dementia, ultimately advancing our understanding and treatment of this devastating condition,” said Sterling Johnson, PhD, Professor of Medicine, University of Wisconsin School of Medicine and Public Health and the CLARiTI study lead. “We are thrilled to partner with Lantheus to use MK-6240 for tau PET imaging in this important study.”

“MK-6240 is poised to play a pivotal role in propelling Alzheimer’s diagnosis and treatment research to new heights,” said Jean-Claude Provost, MD, Chief Medical Officer, Lantheus. “This agreement aligns with Lantheus’ purpose to actively cultivate collaborations that empower researchers worldwide with essential tools to accelerate clinical research and development of therapies. In an era defined by an unprecedented number of Alzheimer’s diagnoses, the CLARiTI study represents a significant milestone in Alzheimer’s research, with the potential to change the trajectory of this degenerative disease.”

About the CLARiTI Study
Clarity in Alzheimer’s Disease and Related Dementias Research Through Imaging (CLARiTI) is a multi-site imaging observational study that will be conducted at all 37 Alzheimer’s Disease Research Centers (ADRCs) in the United States. The study will collect data about the presence, absence or change in characteristic disease biomarkers in people who have various types of dementia or are at risk of developing it. CLARiTI is a five-year study that will enroll 2,000 subjects across the U.S. Data generated from CLARiTI will be made available to the scientific community through the National Alzheimer's Coordinating Center, and biological samples will be analyzed and made available through the National Centralized Repository for Alzheimer’s Disease and Related Dementias.

Please visit https://naccdata.org/nacc-collaborations/clariti for more information about the study.

About Alzheimer’s Disease and Dementia
Alzheimer’s disease is a progressive degenerative brain disease and the most common form of dementia. Dementia is the loss of cognitive functioning and behavioral abilities to such an extent that it interferes with a person’s daily life and activities. Dementia is not a specific disease; it describes a group of symptoms that often has a mixture of etiologies. It is estimated that 6.7 million Americans age 65 and older are currently living with Alzheimer’s dementia. As the population ages, it is projected that by 2050, this number may grow to 12.7 million.1

About Lantheus
Lantheus is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada and Sweden, Lantheus has been providing radiopharmaceutical solutions for more than 65 years. For more information, visit www.lantheus.com.

Safe Harbor for Forward-Looking and Cautionary Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as “designed,” “poised,” “potential,” “will” and other similar terms. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause the Company’s actual results to materially differ from those described in the forward-looking statements are discussed in the Company’s filings with the Securities and Exchange Commission (including those described in the Risk Factors section in the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q).

1Alzheimer’s Association. 2023 Alzheimer’s Disease Facts and Figures. Alzheimer’s Dement 2023;19(4). DOI 10.1002/alz.13016.

Contacts:

Lantheus
Mark Kinarney
Vice President, Investor Relations
978-671-8842
ir@lantheus.com

Melissa Downs
Senior Director, External Communications
646-975-2533
media@lantheus.com


FAQ

What is the name of the investigational F18-labeled PET imaging agent supplied by Lantheus in the collaboration agreement with CLARiTI?

The investigational F18-labeled PET imaging agent supplied by Lantheus is MK-6240.

What is the focus of the CLARiTI study involving MK-6240?

The CLARiTI study focuses on investigating Alzheimer's disease and related dementias using MK-6240 to target tau tangles.

How many subjects will be recruited for the CLARiTI study?

The CLARiTI study will recruit 2,000 subjects.

What is the purpose of using MK-6240 in the CLARiTI study?

The purpose of using MK-6240 in the CLARiTI study is to shed light on the complex interplay of multiple pathologies contributing to dementia.

Who is the lead of the CLARiTI study?

The lead of the CLARiTI study is Sterling Johnson, PhD, Professor of Medicine at the University of Wisconsin School of Medicine and Public Health.

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