Frontotemporal Dementia Pipeline, Clinical Trials Assessment, NDA Approvals 2023 (Updated) | Prevail Therapeutics, Coya Therapeutics, Alector Inc., Passage Bio, WaVe life Sciences, and others.

(Albany, United States) As per DelveInsight's assessment, globally, the Frontotemporal Dementia pipeline constitutes 25+ key companies continuously working towards developing 25+ Frontotemporal Dementia treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analysis DelveInsight.

In the Frontotemporal Dementia pipeline report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, Frontotemporal Dementia NDA approvals (if any), and product development activities comprising the technology, collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

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Key Takeaways from the Frontotemporal Dementia Pipeline Report
• DelveInsight's Frontotemporal Dementia Pipeline analysis depicts a robust space with 25+ active players working to develop 25+ pipeline treatment therapies.
• The leading companies are working in the Frontotemporal Dementia market include Prevail Therapeutics, Coya Therapeutics, Alector, Inc., Passage Bio, WaVe life Sciences, CAMP4 Therapeutics, SOLA Biosciences, Denali Therapeutics, Neurimmune, Autifony Therapeutics, and others.
• Promising Frontotemporal Dementia Pipeline Therapies in the various stages of development include DNL593, Methylprednisolone, Sirolimus, PR006, PBFT02, AL001, TRx0237, Galantamine Hydrobromide, florbetapir 18F, Flortaucipir F18, Memantine Hydrochloride, and others.
• On April 2023, Denali Therapeutics Inc. announced a study of phase 1 & 2 clinical trials for DNL593. This is a Phase 1/2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of DNL593 in two parts followed by an optional open-label extension (OLE) period.
• On April 2023, Prevail Therapeutics announced a study of phase 1 & 2 clinical trials for Methylprednisolone and Sirolimus. Study PRV-FTD101 is a Phase 1/2, multi-center, open-label ascending dose, first-in-human study that will evaluate the safety and effect of intra-cisternal PR006 administration on progranulin protein (PGRN) levels in patients with frontotemporal dementia with progranulin mutations (FTD-GRN). Three escalating dose (low dose, medium dose and high dose) cohorts are planned. The duration of the study is 5 years. During the first year, patients will be evaluated for the effect of PR006 on safety, tolerability, immunogenicity, biomarkers, and efficacy. Patients will follow up for an additional 4 years to monitor safety and changes on selected biomarkers and clinical outcomes.

Frontotemporal Dementia Overview
Frontotemporal dementia (FTD) or frontotemporal degeneration refers to a group of disorders caused by progressive nerve cell loss in the brain's frontal lobes (the areas behind your forehead) or its temporal lobes (the regions behind your ears).

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Frontotemporal Dementia Emerging Drugs Profile

PR 006: Prevail Therapeutics
PR006 is being developed as a potentially disease-modifying, single-dose gene therapy for patients with frontotemporal dementia with GRN mutations (FTD-GRN). PR006 is designed to slow or stop disease progression in FTD-GRN patients by increasing progranulin levels via delivery of a healthy GRN gene into the central nervous system (CNS). PR006 is administered by injection into the cisterna magna, using the well-studied viral vector AAV9.The U.S. FDA has granted Orphan Drug designation for the treatment of FTD and Fast Track designation for the treatment of FTD-GRN. The European Commission has granted orphan designation for PR006 for the treatment of FTD.PR006 is currently being studied in our PROCLAIM trial, a Phase 1/2 clinical trial of PR006 for the treatment of patients with FTD-GRN.

Latozinemab: Alector
AL001 modulates progranulin (PGRN), a key regulator of immune activity in the brain with genetic links to multiple neurodegenerative disorders. We are initially developing AL001 for frontotemporal dementia (FTD) with progranulin mutation (FTD-GRN). The global INFRONT-3 Phase 3 clinical trial is currently enrolling both at-risk and symptomatic participants with FTD-GRN.AL001 is being developed in collaboration with GSK.

PBFT-02: Passage Bio
Passage Bio, gene therapy product candidate, PBFT02, an AAV1 viral vector to deliver a modified DNA encoding the granulin gene (GRN) to a patient's cells. The vector will be delivered directly to the cerebrospinal fluid by a single injection to the cisterna magna (ICM injection). The goal of this vector and delivery approach is to provide higher-than-normal levels of the progranulin protein (PGRN) to the CNS to overcome the progranulin deficiency in GRN gene mutation carriers. Currently the product is in Phase I/II for the treatment of Frontotemporal Dementia.

WVE-004: WaVe life Sciences
WVE-004 is an investigational variant-selective silencing candidate designed to selectively target the transcript variants containing a hexanucleotide repeat expansion (G4C2) in the C9orf72 gene, while sparing the healthy C9orf72 protein. G4C2 expansions are one of the most common genetic causes of the sporadic and inherited forms of ALS and FTD.

EXO-050: Coya Therapeutics
EXO 050, is the lead drug candidate of Coya Therapeutics for the treatment of FTD. Currently, the drug is in Pre-Clinical stage of development for the treatment of FTD. .

Frontotemporal Dementia Pipeline Therapeutics Assessment
There are approx. 25+ key companies which are developing the therapies for Frontotemporal Dementia. The Frontotemporal Dementia companies which have their Frontotemporal Dementia drug candidates in the most advanced stage, i.e. phase III include, Deerland Probiotics & Enzymes.

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Frontotemporal Dementia Drugs and Companies
• DNL593: Denali Therapeutics Inc.
• Methylprednisolone: Eli Lilly and Company
• PBFT02: Passage Bio Inc.

Frontotemporal Dementia Therapeutics Assessment
• Assessment by Stage and Product Type
• Assessment by Route of Administration
• Assessment by Stage and Route of Administration
• Assessment by Molecule Type
• Assessment by Stage and Molecule Type

Some of the Companies in the Frontotemporal Dementia Therapeutics Market include-
Prevail Therapeutics, Coya Therapeutics, Alector, Inc., Passage Bio, WaVe life Sciences, CAMP4 Therapeutics, SOLA Biosciences, Denali Therapeutics, Neurimmune, Autifony Therapeutics, and others.

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Scope of the Frontotemporal Dementia Pipeline Report
• Coverage- Global
• Companies- Prevail Therapeutics, Coya Therapeutics, Alector, Inc., Passage Bio, WaVe life Sciences, CAMP4 Therapeutics, SOLA Biosciences, Denali Therapeutics, Neurimmune, Autifony Therapeutics, and others.
• Therapies- DNL593, Methylprednisolone, Sirolimus, PR006, PBFT02, AL001, TRx0237, Galantamine Hydrobromide, florbetapir 18F, Flortaucipir F18, Memantine Hydrochloride, and others.
• Segmentation: Product Type, Molecule Type, Route of Administration

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Table of Content
1. Introduction
2. Executive Summary
3. Frontotemporal Dementia: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Frontotemporal Dementia- DelveInsight's Analytical Perspective
7. Late Stage Products (Phase III)
8. Latozinemab: Alector
9. Drug profiles in the detailed report…..
10. Mid Stage Products (Phase II)
11. Drug Name: Company Name
12. Drug profiles in the detailed report…..
13. Early Stage Products (Phase I/II)
14. PR 006 : Prevail Therapeutics
15. Drug profiles in the detailed report…..
16. Preclinical and Discovery Stage Products
17. EXO-050: Coya Therapeutics
18. Drug profiles in the detailed report…..
19. Inactive Products
20. Frontotemporal Dementia Key Companies
21. Frontotemporal Dementia Key Products
22. Frontotemporal Dementia- Unmet Needs
23. Frontotemporal Dementia- Market Drivers and Barriers
24. Frontotemporal Dementia- Future Perspectives and Conclusion
25. Frontotemporal Dementia Analyst Views
26. Frontotemporal Dementia Key Companies
27. Appendix

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