Lantheus EU Ltd.

LAS VEGAS, Feb. 27, 2023 /PRNewswire/ -- The prevalence of Alzheimer's disease has been rising over the past few years, which prompts the growing demand for treatment options. The increasing prevalence of Alzheimer's disease and the growing research and development activities to develop novel therapies to treat Alzheimer's disease to drive the market. The companies developing the potential therapies in the last stage of development include Eli Lilly and Company, AB Sciences, AZTherapies, and several others. DelveInsight's ' Alzheimer's Disease Pipeline Insight – 2023 ' report provides comprehensive global coverage of available, marketed, and pipeline Alzheimer's disease therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the Alzheimer's disease pipeline domain. Key Takeaways from the Alzheimer's Disease Pipeline Report DelveInsight's Alzheimer's disease pipeline report depicts a robust space with 150+ active players working to develop 160+ pipeline therapies for Alzheimer's disease treatment. Key Alzheimer's disease companies such as Biogen, AZTherapies, Cerecin, Neurotrope, Synaptogenix, INmune Bio, Cassava Sciences, EIP Pharma, Neuraly, AB Science, Cortexyme, Anavex Life Sciences, Athira Pharma, Time Therapeutics, Denali Therapeutics Inc., Alector Inc., Lexeo Therapeutics, TrueBinding, Inc., Vaccinex Inc., Annovis Bio Inc., Eisai Inc., Hoffmann-La Roche, Ionis Pharmaceuticals, Inc., Otsuka Pharmaceutical Co., Ltd., Cognition Therapeutics, Merck Sharp & Dohme LLC, ImmunoBrain Checkpoint, AbbVie, AriBio Co., Ltd., Oryzon Genomics S.A., Eli Lilly and Company, Neurokine Therapeutics, Excelsior, Seelos Therapeutics, Inc., Janssen Research & Development, LLC, Shanghai Hengrui Pharmaceutical Co., Ltd., reMYND, Alzinova AB, VTBIO Co. LTD, BioVie Inc., Prothena Corporation plc, Coya Therapeutics, Inc., and others are evaluating new Alzheimer's disease drugs to improve the treatment landscape. Promising Alzheimer's disease pipeline therapies in various stages of development include ALZT-OP1, Tricaprilin, Bryostatin-1, INB03, Sumifilam, Neflamapimod, Pegylated exenatide, NLY-02, Masitinib, Atuzaginstat, COR588, Blarcamesine, NDX-1017, Bromocriptine, DNL788, AL002, CMS121, LX1001, TB006, Pepinemab, Posiphen, E2814, RO7126209, IONIS MAPTRx, Brexpiprazole, CT1812, MK-1942, IBC Ab002, ABBV-916, AR1001, ORY-2001, LY3372689, MW150, EX039, SLS-005, Seltorexant, Donanemab, SHR-1707, REM0046127, ALZ-101, VT301, NE3107, PRX005, MK-6240, and others. In February 2023, Lantheus Holdings, Inc. announced it had acquired Knoxville-based Cerveau Technologies, Inc. ("Cerveau"). Cerveau's asset is MK-6240, a second-generation F 18-labeled positron emission tomography ("PET") imaging agent that targets Tau tangles in Alzheimer's disease.Under the terms of the agreement, Lantheus will pay an upfront payment and potential additional development and commercial milestone payments. Additionally, Lantheus will pay double-digit royalty payments for research revenue and commercial sales. In January 2023, Prothena Corporation plc announced positive topline Phase I single ascending dose (SAD) study results for PRX005, a potentially best-in-class investigational tri-epitopic antibody for the treatment of Alzheimer's disease that specifically binds with high affinity to the R1, R2, and R3 repeats within the microtubule binding region (MTBR) of tau and targets both 3R and 4R tau isoforms. The results of the study found all three dose level cohorts of PRX005 to be generally safe and well tolerated, meeting the Phase 1 SAD study primary objective. None of the treatment emergent adverse events (TEAE) were serious. No clinically relevant changes were observed in other safety parameters. PRX005 also met key pharmacokinetic (PK) and immunogenicity secondary endpoints. In January 2023, Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the accelerated approval submission of donanemab for the treatment of early symptomatic Alzheimer's disease due to the limited number of patients with at least 12 months of drug exposure data provided in the submission. No other deficiencies in the application were noted.The confirmatory Phase 3 TRAILBLAZER-ALZ 2 trial remains ongoing, with topline data read-out expected in Q2 2023, and will form the basis of donanemab's application for traditional approval shortly thereafter. Lilly will continue to work with the FDA to evaluate the fastest pathway to make this potential treatment option widely available to patients. In January 2023, Coya Therapeutics, Inc. announced the recent publication of an article entitled "Ex vivo expanded human regulatory T cells modify neuroinflammation in a preclinical model of Alzheimer's Disease" in the peer-reviewed journal Acta Neuropathologica Communications.Furthermore, Treg-treated mice showed a significant reduction in total and plaque-associated microglia as well as reactive astrocytes in the dentate gyrus and frontal cortex versus untreated mice. The reduction in the number of plaque-associated glial cells and suppression of pro-inflammatory signaling pathways within these cells following Treg therapy may attenuate the contribution of these toxic glial cells in AD pathology resulting in mitigation of amyloid burden. In November 2022, Eli Lilly and Company announced that donanemab met all primary and secondary endpoints for the 6-month primary outcome analysis in the Phase III TRAILBLAZER-ALZ 4 study, providing the first active comparator data on amyloid plaque clearance in patients with early symptomatic Alzheimer's disease treated with amyloid-targeting therapies. Donanemab is an investigational antibody that targets a modified form of beta-amyloid plaque called N3pG. Request a sample and discover the recent advances in Alzheimer's disease drug treatment @ Alzheimer's Disease Pipeline Report The Alzheimer's disease pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage Alzheimer's disease drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the Alzheimer's disease clinical trial landscape. Alzheimer's Disease Overview Alzheimer's disease (AD) is a slowly progressive brain disease that manifests itself many years before symptoms appear. It is the leading cause of dementia, accounting for 60% to 80% of cases. The accumulation of the protein fragment beta-amyloid (plaques) outside neurons in the brain and twisted strands of the protein tau (tangles) inside neurons are the hallmark pathologies of Alzheimer's disease. Alzheimer's disease is a progressive disease, so the symptoms worsen over time. Memory loss is a key feature, and it is often one of the first Alzheimer's disease symptoms to appear. The other Alzheimer's disease symptoms include cognitive deficits, problems with recognition, problems with spatial awareness, and others. A thorough clinical evaluation, a detailed patient history, and various specialized tests are used to make an Alzheimer's disease diagnosis. Clinical diagnosis, which is usually made during the early stages of the disease, lumbar puncture, and imaging studies are all methods of diagnosing Alzheimer's disease. Treatment for Alzheimer's disease includes options that may alleviate symptoms and improve quality of life. To treat cognitive symptoms, the FDA has approved two types of medications to treat cognitive symptoms: cholinesterase inhibitors (Aricept, Exelon, Razadyne) and memantine (Namenda). Other non-pharmacological therapies are also used to maintain or improve cognitive function, daily living ability, or overall quality of life. Find out more about drugs for Alzheimer's disease @ New Alzheimer's Disease Drugs A snapshot of the Alzheimer's Disease Pipeline Drugs mentioned in the report: Learn more about the emerging Alzheimer's disease pipeline therapies @ Alzheimer's Disease Clinical Trials Alzheimer's Disease Therapeutics Assessment The Alzheimer's disease pipeline report proffers an integral view of Alzheimer's disease emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Alzheimer's Disease Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Parenteral, Intravenous, Subcutaneous, Topical Therapeutics Assessment By Molecule Type: Monoclonal Antibody, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: Amyloid beta-protein inhibitors, Inflammation mediator inhibitors, Immunostimulants, Tumour necrosis factor alpha inhibitors, Microfilament protein modulators, Angiogenesis inhibitors, Colony stimulating factor inhibitors, Coronavirus-3C-like-proteinase inhibitors, Endopeptidase Clp inhibitors, Focal adhesion protein-tyrosine kinase inhibitors, Lyn protein-tyrosine kinase inhibitors, Macrophage colony-stimulating factor receptor modulators, Mast cell inhibitors, Platelet-derived growth factor receptor antagonists, Protein tyrosine kinase inhibitors, Proto oncogene protein c-kit inhibitors, Proto-oncogene protein c-fyn modulators, Type 3 fibroblast growth factor receptor antagonists Key Alzheimer's Disease Companies: Biogen, AZTherapies, Cerecin, Neurotrope, Synaptogenix, INmune Bio, Cassava Sciences, EIP Pharma, Neuraly, AB Science, Cortexyme, Anavex Life Sciences, Athira Pharma, Time Therapeutics, Denali Therapeutics Inc., Alector Inc., Lexeo Therapeutics, TrueBinding, Inc., Vaccinex Inc., Annovis Bio Inc., Eisai Inc., Hoffmann-La Roche, Ionis Pharmaceuticals, Inc., Otsuka Pharmaceutical Co., Ltd., Cognition Therapeutics, Merck Sharp & Dohme LLC, ImmunoBrain Checkpoint, AbbVie, AriBio Co., Ltd., Oryzon Genomics S.A., Eli Lilly and Company, Neurokine Therapeutics, Excelsior, Seelos Therapeutics, Inc., Janssen Research & Development, LLC, Shanghai Hengrui Pharmaceutical Co., Ltd., reMYND, Alzinova AB, VTBIO Co. LTD, BioVie Inc., Prothena Corporation plc, Coya Therapeutics, Inc., and others. Key Alzheimer's Disease Pipeline Therapies: ALZT-OP1, Tricaprilin, Bryostatin-1, INB03, Sumifilam, Neflamapimod, Pegylated exenatide, NLY-02, Masitinib, Atuzaginstat, COR588, Blarcamesine, NDX-1017, Bromocriptine, DNL788, AL002,CMS121, LX1001, TB006, Pepinemab, Posiphen, E2814, RO7126209, IONIS MAPTRx, Brexpiprazole, CT1812, MK-1942, IBC Ab002, ABBV-916, AR1001, ORY-2001, LY3372689, MW150, EX039, SLS-005, Seltorexant, Donanemab, SHR-1707, REM0046127, ALZ-101, VT301, NE3107, PRX005, MK-6240, and others. Dive deep into rich insights for new drugs for Alzheimer's disease treatment; visit @ Alzheimer's Disease Medications Table of Contents For further information on the Alzheimer's disease pipeline therapeutics, reach out @ Alzheimer's Disease Drug Treatment Related Reports Alzheimer's Disease Epidemiology Alzheimer's Disease Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted Alzheimer's disease epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. 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CHICAGO--(BUSINESS WIRE)-- Contrast-enhanced ultrasound (CEUS) is more accurate and reliable than MRI for examining certain liver and kidney nodules, according to two new studies published in the Journal of Ultrasound in Medicine (JUM) and highlighted by the International Contrast Ultrasound Society (ICUS). “We found that CEUS is a better and less expensive first-step evaluation for newly-discovered liver nodules,” said Dr. Stephanie Wilson, principal investigator of the liver CEUS study, which followed 196 patients at the University of Calgary for two years. Dr. Wilson is a clinical professor of radiology and gastroenterology at the University of Calgary and Co-President of ICUS. “CEUS found malignant or pre-malignant diagnoses that would likely have been missed or delayed if we had not used CEUS in these patients,” according to Dr. Wilson. “In addition, CEUS quickly and reliably identified benign lesions and pseudo-lesions, sparing these patients the costs and risks associated with unnecessary downstream testing and procedures,” she added. This study shows that CEUS scans are at least equivalent if not superior to MRI for evaluating these liver lesions, and CEUS should be the first investigation for nodules found on surveillance for liver cancer, according to Dr. Wilson. She called upon the American Association for the Study of Liver Diseases (AASLD) to include CEUS in its liver imaging guidelines, along with MRI and CT. Meanwhile, an Ohio team reviewed clinical data over a 10 year period to assess the accuracy of CEUS diagnoses of benign kidney nodules in 341 patients. Their blinded analysis found that none of the CEUS diagnoses changed during that period. “Our data confirm that when CEUS determines a kidney mass is benign, the mass is benign and no further follow up is needed -- sparing the patient from unnecessary downstream tests, anxiety and costs,” according to Dr. Richard G. Barr, the lead author of the kidney CEUS study. Dr. Barr is a professor of radiology at the Northeast Ohio Medical University and treasurer of ICUS. CEUS is a non-invasive imaging tool that is safely and routinely used worldwide to help identify and characterize cancers, diagnose heart and vascular disease, monitor chronic gastro-intestinal diseases and monitor therapy. Ultrasound contrast agents are administered intravenously to enhance the images produced by ultrasound scans, allowing for visualization of abnormal microvascular blood flow patterns in real time. “It is important to remember that ultrasound contrast agents do not contain iodinated dye and do not harm the kidneys, making CEUS the examination of choice for patients with renal insufficiency,” according to Dr. Barr. “In addition, CEUS allows for improved visualization of enhancement patterns in real time, the thin slice thickness of CEUS allows for evaluation of small nodules, multiplanar imaging allows for improved visualization and confirmation of enhancement, and multiple doses may be used during the same examination to provide an opportunity to image the lesion thoroughly,” Dr. Barr said. Since kidney masses are often found on imaging for other indications, CEUS offers an essential imaging option because it is safe, accurate, low-cost, radiation-free and can help these patients avoid additional unnecessary tests and surgery, he added. “Further, due to radiation exposure associated with CT, we believe CT should not be used as the first line imaging modality for assessing cystic lesions that are most probably benign in character,” Dr. Barr said, citing the FDA’s recent white paper addressing unnecessary radiation exposure from medical imaging. Many urologists are now also finding that CEUS is essential for diagnosing indeterminate kidney masses. “If CEUS shows concern for malignancy of renal masses, we have complete confidence in proceeding with treatment; and if CEUS confirms a lesion to be benign our Urology group feels equally assured that it is safe to follow such lesions over time and to forego treatment,” said Dr. Daniel Ricchiuti, a urologist in Boardman, Ohio. The Canadian liver study represents the first prospective comparison of CEUS and contrast-enhanced MRI for assessment of newly-discovered liver nodules, according to Dr. Wilson. She said her study showed that CEUS offers superior sensitivity when compared to MRI (81% vs 64%) for the diagnosis of malignancy, without compromising specificity (92% vs. 93%). In addition, CEUS was more likely than MRI to reproduce and characterize the nodule found on screening (97% vs. 78.5%). Nonetheless, MRI remains an essential tool for managing patients with malignant tumors, particularly for staging these tumors prior to treatment, according to Dr. Wilson. Four ultrasound contrast agents are available in various countries around the world: Sonovue (Lumason in the USA), manufactured and sold by Bracco; Definity (Luminity in Europe), manufactured and sold by Lantheus; and Optison and Sonazoid, manufactured and sold by GE Healthcare. ABOUT ICUS: The International Contrast Ultrasound Society (ICUS) is a non-profit medical society dedicated to advancing the medically appropriate use of contrast enhanced ultrasound (CEUS) to improve patient care and outcomes. ICUS offers free membership, CME-accredited webinars, newsletters, a comprehensive CEUS website and new mobile app, “ICUS Connect.” To join ICUS and learn more about CEUS, please visit .