Epilepsy - Pipeline Insight, 2021

July 2021 | 120 pages | ID: E52883187B7AEN
DelveInsight

Abstracts

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DelveInsight’s, “Epilepsy – Pipeline Insight, 2021,” report provides comprehensive insights about 70+ companies and 70+ pipeline drugs in Epilepsy pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Epilepsy Understanding

Epilepsy: Overview

Epilepsy is a chronic noncommunicable disease of the brain that affects around 50 million people worldwide. It is characterized by recurrent seizures, which are brief episodes of involuntary movement that may involve a part of the body (partial) or the entire body (generalized) and are sometimes accompanied by loss of consciousness and control of bowel or bladder function. Seizure episodes are a result of excessive electrical discharges in a group of brain cells. Characteristics of seizures vary and depend on where in the brain the disturbance first starts, and how far it spreads. Temporary symptoms occur, such as loss of awareness or consciousness, and disturbances of movement, sensation (including vision, hearing and taste), mood, or other cognitive functions. Epilepsy is not contagious. Although many underlying disease mechanisms can lead to epilepsy, the cause of the disease is still unknown in about 50% of cases globally. The causes of epilepsy are divided into the following categories: structural, genetic, infectious, metabolic, immune and unknown. Up to 70% of people living with epilepsy could become seizure free with appropriate use of antiseizure medicines. A documented etiology of the seizure and an abnormal electroencephalography (EEG) pattern are the two most consistent predictors of seizure recurrence. Some treatment options include: Anti-epileptic (anticonvulsant, antiseizure) drugs, Vagus nerve stimulator, Ketogenis diet and brain surgery. Research into new treatments is ongoing.

'Epilepsy - Pipeline Insight, 2021' report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Epilepsy pipeline landscape is provided which includes the disease overview and Epilepsy treatment guidelines. The assessment part of the report embraces, in depth Epilepsy commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Epilepsy collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence Epilepsy R&D. The therapies under development are focused on novel approaches to treat/improve Epilepsy.

Epilepsy Emerging Drugs Chapters

This segment of the Epilepsy report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Epilepsy Emerging Drugs

• GWP42003-P: GW Research

Epidiolex (formerly, GWP42003-P) is an oral cannabidiol solution that GW Pharmaceuticals developed. The U.S. Food and Drug Administration (FDA) approved it to treat seizures in patients with Dravet syndrome and Lennox-Gastaut syndrome age 1 and older. Epidiolex is a plant-derived cannabidiol, a non-psychoactive marijuana extract. It is currently being investigated in Phase III clinical trial to treat Epilepsy.

• Ganaxolone: Marinus Pharmaceuticals

Ganaxolone is a GABAA receptor modulator that acts by regulating brain activity is being evaluated in Phase III stage of development. This process can include inhibiting the abnormal electrical discharges that cause seizures and status epilepticus or restoring balance in disrupted neuronal activity in other CNS disorders. Because ganaxolone modulates both synaptic and extrasynaptic GABAA receptors and is unique relative to other approved antiepileptic drugs, we believe it has the potential to treat seizures resistant to other available medications. These binding sites, including the extrasynaptic GABAA receptor, may also be important in treating status epilepticus and other brain disorders.

• XEN496: Xenon Pharmaceuticals

XEN496, a Kv7 potassium channel modulator that is a proprietary pediatric formulation of the active ingredient ezogabine being developed for the treatment of KCNQ2 developmental and epileptic encephalopathy (KCNQ2-DEE). With the U.S. Food and Drug Administration (FDA) having completed its review of the clinical trial protocol, Xenon is on track to initiate the XEN496 Phase 3 clinical trial in pediatric patients with KCNQ2-DEE. In addition, Xenon has received a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA), which recommends the granting of an orphan medicinal product designation for XEN496 for the treatment of KCNQ2-DEE. This European designation is in addition to the FDA granting Fast Track designation for XEN496 for the treatment of seizures associated with KCNQ2-DEE as well as Orphan Drug Designation (ODD) for the treatment of KCNQ2-DEE.

• CVL-865: Cereval therapeutics

The positive allosteric modulator (PAM) of GABAA channels, CVL-865 has been shown in a phase II trial to have pronounced anticonvulsant activity in patients with photosensitive epilepsy, with efficacy similar to lorazepam. CVL-865 acts at GABAA channels with ?2, ?3, and ?5 subunits, known to have anticonvulsant (?2 only), analgesic, anxiolytic, and muscle-relaxing properties from GABAergic PAMs. It is hoped that CVL-865, by selectively modulating ?2, ?3, and ?5 will enable higher receptor occupancy than can be achieved with non-selective benzodiazepines and achieve seizure suppression with greater tolerability owing to fewer sedative or cognitive effects.

• ES481: ES Therapeutics

ES 481 is being developed by ES Therapeutics for the treatment of Epilepsy. ES therapeutics is conducting Phase IIA single-arm exploratory clinical study in up to 12 adult subjects aged 18 and older with primary glioma, IDH1 mutation, and uncontrolled focal-onset seizure activity to determine the potential efficacy, safety and pharmacokinetics of ES-481 as adjunctive therapy in glioma-associated epilepsy and to assess for potential anti-tumorigenic effects.

Further product details are provided in the report……..

Epilepsy: Therapeutic Assessment

This segment of the report provides insights about the different Epilepsy drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Epilepsy

There are approx. 70+ key companies which are developing the therapies for Epilepsy. The companies which have their Epilepsy drug candidates in the most advanced stage, i.e. Phase III include, GW Research.

• Phases

DelveInsight’s report covers around 70+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Epilepsy pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Epilepsy: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Epilepsy therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Epilepsy drugs.

Epilepsy Report Insights

• Epilepsy Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Epilepsy Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Epilepsy drugs?
• How many Epilepsy drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Epilepsy?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Epilepsy therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Epilepsy and their status?
• What are the key designations that have been granted to the emerging drugs?

Contents

Introduction
Executive Summary
Epilepsy: Overview
  Causes
  Mechanism of Action
  Signs and Symptoms
  Diagnosis
  Disease Management
Pipeline Therapeutics
  Comparative Analysis
Therapeutic Assessment
  Assessment by Product Type
  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
Late Stage Products (Phase III)
  Comparative Analysis
GWP42003-P: GW Research
  Product Description
  Research and Development
  Product Development Activities
Drug profiles in the detailed report…..
Mid Stage Products (Phase II)
  Comparative Analysis
CVL-865: Cereval therapeutics
  Product Description
  Research and Development
  Product Development Activities
Drug profiles in the detailed report…..
Early stage products (Phase I)
  Comparative Analysis
OPC-214870: Otsuka Pharmaceutical
  Product Description
  Research and Development
  Product Development Activities
Drug profiles in the detailed report…..
Inactive Products
  Comparative Analysis
Epilepsy Key Companies
Epilepsy Key Products
Epilepsy- Unmet Needs
Epilepsy- Market Drivers and Barriers
Epilepsy- Future Perspectives and Conclusion
Epilepsy Analyst Views
Epilepsy Key Companies
Appendix

List Of Tables

LIST OF TABLES

Table 1 Total Products for Epilepsy
Table 2 Late Stage Products
Table 3 Mid Stage Products
Table 4 Early Stage Products
Table 5 Pre-clinical & Discovery Stage Products
Table 6 Assessment by Product Type
Table 7 Assessment by Stage and Product Type
Table 8 Assessment by Route of Administration
Table 9 Assessment by Stage and Route of Administration
Table 10 Assessment by Molecule Type
Table 11 Assessment by Stage and Molecule Type
Table 12 Inactive Products

List Of Figures

LIST OF FIGURES

Figure 1 Total Products for Epilepsy
Figure 2 Late Stage Products
Figure 3 Mid Stage Products
Figure 4 Early Stage Products
Figure 5 Preclinical and Discovery Stage Products
Figure 6 Assessment by Product Type
Figure 7 Assessment by Stage and Product Type
Figure 8 Assessment by Route of Administration
Figure 9 Assessment by Stage and Route of Administration
Figure 10 Assessment by Molecule Type
Figure 11 Assessment by Stage and Molecule Type
Figure 12 Inactive Products