Diabetic Peripheral Neuropathy Pipeline Insight

DelveInsight’s, “Diabetic Peripheral Neuropathy -Pipeline Insights, 2021,” report provides comprehensive insights about 10+ companies and 10+ pipeline drugs in Diabetic Peripheral Neuropathy 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

Diabetic Peripheral Neuropathy Understanding

Diabetic Peripheral Neuropathy: Overview

Diabetic neuropathy is nerve damage caused by diabetes. When it affects the arms, hands, legs and feet, it is known as diabetic peripheral neuropathy.


Diabetic peripheral neuropathy is different from peripheral arterial disease (poor circulation), which affects the blood vessels rather than the nerves. Three different groups of nerves can be affected by diabetic neuropathy:

  • Sensory nerves, which enable people to feel pain, temperature and other sensations
  • Motor nerves, which control the muscles and give them their strength and tone
  • Autonomic nerves, which allow the body to perform certain involuntary functions, such as sweating


 Diabetic peripheral neuropathy does not emerge overnight. Instead, it usually develops slowly and worsens over time. Some patients have this condition long before they are diagnosed with diabetes. Having diabetes for several years may increase the likelihood of having diabetic neuropathy. The loss of sensation and other problems associated with nerve damage make a patient prone to developing skin ulcers (open sores) that can become infected and may not heal. This serious complication of diabetes can lead to loss of a foot, a leg or even a life.

Symptoms

If a person has peripheral neuropathy, his/her feet, legs, hands, or arms may feel:

  • burning
  • tingling, like “pins and needles”
  • numb
  • painful
  • weak

The person may feel extreme pain in feet, legs, hands, and arms, even when they are touched lightly. They may also have problems sensing pain or temperature in these parts of their body. Symptoms are often worse at night. Most of the time, the patients will have symptoms on both sides of their body.

Diagnosis

To diagnose diabetic peripheral neuropathy, the foot and ankle surgeon will obtain the patient’s history of symptoms and will perform simple in-office tests on the feet and legs. This evaluation may include assessment of the patient’s reflexes, ability to feel light touch and ability to feel vibration. In some cases, additional neurologic tests may be ordered.

Treatment

First and foremost, treatment of diabetic peripheral neuropathy centers on control of the patient’s blood sugar level. In addition, various options are used to treat the painful symptoms. Medications are available to help relieve specific symptoms, such as tingling or burning. Sometimes a combination of different medications is used. In some cases, the patient may also undergo physical therapy to help reduce balance problems or other symptoms.

Diabetic Peripheral Neuropathy Emerging Drugs Chapters

This segment of the Diabetic Peripheral Neuropathy 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.

Diabetic Peripheral Neuropathy Emerging Drugs

  • FE-SYHA1402: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

ZhongQi Pharmaceutical Technology is conducting a multiple doses study to evaluate the safety, tolerability, pharmacokinetics (including food effect) of SYHA1402 in healthy subjects. This study consists of two parts: The objective of the food effect study (Part 1) is to investigate the effect of food on the pharmacokinetic profiles of SYHA1402 tablets under fed and fasted conditions following the oral administration of SYHA1402. The primary objective of the multiple doses study (Part 2) is to investigate safety, tolerability and Pharmacokinetics of SYHA1402 in healthy subjects following oral administration of Multiple rising doses. Secondary objectives are the exploration of pharmacokinetics (PK) following multiple oral doses.


  • VM202: Helixmith

VM202 (donaperminogene seltoplasmid) is a first-in-class, proprietary, non-viral, potentially regenerative plasmid DNA gene therapy. VM202 is a novel genomic cDNA hybrid human hepatocyte growth factor (HGF) gene with a novel and proprietary coding sequence (HGF-X7) expressing two isoforms - a configuration that closely mimics HGF productions in humans that is needed for optimal therapeutic benefits. Because there is no change in the coding region of the HGF gene, HGF proteins generated from VM202 are identical to wildtype human HGF proteins.


  • NYX-2925: Aptinyx

NYX-2925 is a novel, oral small molecule NMDA receptor modulator in development for the treatment of chronic pain. Dysregulation of glutamatergic circuits in the brain is involved in the development of centralized chronic pain. NYX-2925 is in late stage clinical development across two chronic pain indications -Painful Diabetic Peripheral Neuropathy and Fibromyalgia.


  • LX9211: Lexicon Pharmaceuticals

LX9211 is a potent, orally delivered, selective small molecule inhibitor of AAK1, a target discovered and extensively characterized in an alliance with Bristol Myers Squibb. Preclinical data demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain. Lexicon has exclusive research, development and commercialization rights to LX9211 and additional compounds acting through AAK1.

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

Diabetic Peripheral Neuropathy: Therapeutic Assessment

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


  • Major Players in Diabetic Peripheral Neuropathy

There are approx. 10+ key companies which are developing the therapies for Diabetic Peripheral Neuropathy. The companies which have their Diabetic Peripheral Neuropathy drug candidates in the most advanced stage, i.e. phase III include, Helixmith Co., Ltd. and Daiichi Sankyo.

 Phases

DelveInsight’s report covers around 10+ products under different phases of clinical development like

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


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

  • Infusion
  • Intradermal
  • Intramuscular
  • Intranasal
  • Intravaginal
  • Oral
  • Parenteral
  • Subcutaneous
  • Topical.
  • Molecule Type


Products have been categorized under various Molecule types such as

  • Gene therapies
  • Small molecule
  • Product Type

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

Diabetic Peripheral Neuropathy: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Diabetic Peripheral Neuropathy 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 Diabetic Peripheral Neuropathy drugs.

Report Highlights

  • The companies and academics are working to assess challenges and seek opportunities that could influence Diabetic Peripheral Neuropathy R&D. The therapies under development are focused on novel approaches to treat/improve Diabetic Peripheral Neuropathy.
  • In August 2020, Sonnet BioTherapeutics signed a Letter of Intent for potential licensing of neuropathies asset to new Life Therapeutics. It has executed a letter of intent to negotiate an agreement to license its SON-081 and SON-080 assets, both low-dose formulations of Interleukin 6 (IL-6), for diabetic peripheral neuropathy (DPN) and chemotherapy-induced peripheral neuropathy (CIPN) to New Life Therapeutics of Singapore.
  • In August 2020, Kineta got Clinical Trial Application (CTA) approval in the Netherlands for initiation of a first in-human clinical trial of KCP506. KCP506 is a first-in-class α9α10 nicotinic acetylcholine receptor (nAChR) antagonist in development for the treatment of chronic neuropathic pain. KCP506 may potentially be an effective treatment for many types of chronic neuropathic pain including radiculopathy, chemotherapy-induced peripheral neuropathy and diabetic neuropathy.
  • In August 2020, Aptinyx announced the recommencement of Phase 2 study of NYX-2925 in patients with painful diabetic peripheral neuropathy -late 2020/early 2021.

Diabetic Peripheral Neuropathy Report Insights

  • Diabetic Peripheral Neuropathy Pipeline Analysis
  • Therapeutic Assessment
  • Unmet Needs
  • Impact of Drugs

Diabetic Peripheral Neuropathy 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 Diabetic Peripheral Neuropathy drugs?
  • How many Diabetic Peripheral Neuropathy drugs are developed by each company?
  • How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Diabetic Peripheral Neuropathy?
  • What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Diabetic Peripheral Neuropathy 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 Diabetic Peripheral Neuropathy and their status?
  • What are the key designations that have been granted to the emerging drugs?

Key Players

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
  • Helixmith
  • Aptinyx
  • Lexicon Pharmaceuticals
  • Lateral Pharma Pty Ltd.
  • SIMR (Australia) Biotech Pty Ltd.
  • WinSanTor, Inc.
  • Eli Lilly and Company
  • Daiichi Sankyo, Inc.
  • Avazzia, Inc.

Key Products

  • FE-SYHA1402
  • FE-SYHA1402
  • NYX-2925
  • LX9211
  • LAT8881
  • SR419
  • WST-057 (4% pirenzepine) Lose Dose 2mL
  • LY3016859

 

Introduction

Executive Summary

Diabetic Peripheral Neuropathy: 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

Diabetic Peripheral Neuropathy – DelveInsight’s Analytical Perspective

In-depth Commercial Assessment

• Diabetic Peripheral Neuropathy companies’ collaborations, Licensing, Acquisition -Deal Value Trends

Diabetic Peripheral Neuropathy Collaboration Deals

• Company-Company Collaborations (Licensing / Partnering) Analysis

• Company-University Collaborations (Licensing / Partnering) Analysis

Late Stage Products (Phase III)

• Comparative Analysis

Engensis: Helixmith Co., Ltd.

• Product Description

• Research and Development

• Product Development Activities

Mid Stage Products (Phase II)

• Comparative Analysis

Aptinyx: NYX-2925

• Product Description

• Research and Development

• Product Development Activities

LX9211: Lexicon Pharmaceuticals

• Product Description

• Research and Development

• Product Development Activities

Drug profiles in the detailed report…..

Early Stage Products (Phase I)

• Comparative Analysis

FE-SYHA1402: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

• Product Description

• Research and Development

• Product Development Activities

SR419: SIMR (Australia) Biotech Pty Ltd.

• Product Description

• Research and Development

• Product Development Activities

Drug profiles in the detailed report…..

Inactive Products

Comparative Analysis

• Diabetic Peripheral Neuropathy Key Companies

• Diabetic Peripheral Neuropathy Key Products

• Diabetic Peripheral Neuropathy- Unmet Needs

Diabetic Peripheral Neuropathy- Market Drivers and Barriers

• Diabetic Peripheral Neuropathy- Future Perspectives and Conclusion

• Diabetic Peripheral Neuropathy Analyst Views

• Diabetic Peripheral Neuropathy Key Companies

Appendix

List of Tables

 Table 1 Total Products for Diabetic Peripheral Neuropathy

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

 Figure 1 Total Products for Diabetic Peripheral Neuropathy

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

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

• Helixmith

• Aptinyx

• Lexicon Pharmaceuticals

• Lateral Pharma Pty Ltd.

• SIMR (Australia) Biotech Pty Ltd.

• WinSanTor, Inc.

• Eli Lilly and Company

• Daiichi Sankyo, Inc.

• Avazzia, Inc.

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