DelveInsight Evaluates a Robust Alzheimer's Disease Pipeline as 150+ Influential Pharma Players to Set Foot in the Domain

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Feb 27, 2023, 10:30 ET

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:

Drugs	Company	Phase	MoA	RoA
Donanemab	Eli Lilly and Company	Preregistration	Immunomodulators	Intravenous
Ibuprofen/sodium cromoglicate	AZTherapies	Phase III	Amyloid beta-protein inhibitors; Inflammation mediator inhibitors	Oral inhalation
Simufilam	Cassava Sciences	Phase III	Microfilament protein modulators	Oral
Masitinib	AB Science	Phase III	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	Oral
Pegipanermin	INmune Bio	Phase II	Immunostimulants; Tumour necrosis factor alpha inhibitors	NA
IBC-Ab002	Immunobrain Checkpoint	Phase I	Programmed cell death-1 ligand-1 inhibitors	Intravenous

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

1.	Alzheimer's Disease Pipeline Report Introduction
2.	Alzheimer's Disease Pipeline Report Executive Summary
3.	Alzheimer's Disease Pipeline: Overview
4.	Analytical Perspective In-depth Commercial Assessment
5.	Alzheimer's Disease Clinical Trial Therapeutics
6.	Alzheimer's Disease Pipeline: Late Stage Products (Pre-registration)
6.1.	Donanemab: Eli Lilly and Company
7.	Alzheimer's Disease Pipeline: Late Stage Products (Phase III)
7.1.	Masitinib: AB Science
8.	Alzheimer's Disease Pipeline: Mid Stage Products (Phase II)
8.1.	Pegipanermin: INmune Bio
9.	Alzheimer's Disease Pipeline: Early Stage Products (Phase I)
9.1.	IBC-Ab002: Immunobrain Checkpoint
10.	Alzheimer's Disease Pipeline Therapeutics Assessment
11.	Inactive Products in the Alzheimer's Disease Pipeline
12.	Company-University Collaborations (Licensing/Partnering) Analysis
13.	Key Companies
14.	Key Products in the Alzheimer's Disease Pipeline
15.	Unmet Needs
16.	Market Drivers and Barriers
17.	Future Perspectives and Conclusion
18.	Analyst Views
19.	Appendix

For further information on the Alzheimer's disease pipeline therapeutics, reach out @ Alzheimer's Disease Drug Treatment

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