Dyskinesia - Pipeline Insight, 2024

This “Dyskinesia - Pipeline Insight, 2024,” report provides comprehensive insights about 20+ companies and 22+ pipeline drugs in Dyskinesia 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

Dyskinesia Understanding

Dyskinesia: Overview

Dyskinesia’s are involuntary, erratic, writhing movements of the face, arms, legs or trunk. They are often fluid and dance-like, but they may also cause rapid jerking or slow and extended muscle spasms. They are not a symptom of Parkinson's itself. Rather, they are a complication from some Parkinson's medications. They may be caused by systemic, metabolic, endocrinologic, structural, vascular, infectious or inherited degenerative conditions, or be toxin- or drug-induced. Dyskinesia’s usually begin after a few years of treatment with levodopa and can often be alleviated by adjusting dopaminergic medications. Younger people with PD are thought to develop earlier motor fluctuations and dyskinesia’s in response to levodopa. Dyskinesia’s may be mild and non-bothersome, or they can be severe. Most people with Parkinson’s prefer to be “on” with some dyskinesia’s rather than “off” and unable to move well. However, for some people, dyskinesia’s can be severe enough that they interfere with normal functioning. The most common kind of dyskinesias are “peak dose.” These occur when the concentration of levodopa in the blood is at its highest - usually one to two hours after the persons takes it.

Dyskinesia is a complication of long-term levodopa use in people who have had Parkinson's for several years. Other risk factors include being younger at diagnosis and using higher amounts of levodopa for longer periods of time. Researchers don't know exactly why dyskinesia develops, but they believe a number of brain chemicals, including serotonin, glutamate and dopamine, play a role. Dopamine is particularly important. In Parkinson's, the brain cells that make dopamine are lost, so dopamine levels decrease. Levodopa temporarily restores dopamine, but because the medication has to be taken several times per day, dopamine levels rise and fall. These fluctuating levels, and the continued loss of dopamine-producing brain cells, make it impossible to keep a steady level of dopamine, which contributes to dyskinesia.

With many non-drug-induced dyskinesias, treatment of the underlying condition may be sufficient to eliminate the movements, although temporary treatment may be required to control the movements if they are severe. Drug-induced dyskinesias often resolve when the offending drug is discontinued. A notable exception is tardive dyskinesia, which is caused by exposure to dopamine receptor blocking drugs, the majority of which are antipsychotic agents. Tardive dyskinesias will persist, or may even develop after the causative agent has been stopped and may not spontaneously remit. Another commonly encountered form of drug-induced dyskinesia is seen in patients with Parkinson's disease who are receiving levodopa. Medications which deplete dopamine are most successful in treating choreiform dyskinesias, although anticholinergics, GABAergics, serotonergics, and calcium channel blocking agents have been reportedly beneficial in some cases. Treatment of levodopa-induced dyskinesias requires manipulation of the patient's antiparkinsonian drug regimen.

Dyskinesia - Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Dyskinesia pipeline landscape is provided which includes the disease overview and Dyskinesia treatment guidelines. The assessment part of the report embraces, in depth Dyskinesia 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, Dyskinesia 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 Dyskinesia R&D. The therapies under development are focused on novel approaches to treat/improve Dyskinesia.

Dyskinesia Emerging Drugs Chapters

This segment of the Dyskinesia report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, 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.

Dyskinesia Emerging Drugs

JM-010: Contera Pharma JM-010 is developed as an innovative approach to accelerate the development of new treatment options for Parkinson’s disease patients suffering from dyskinesia.JM-010 acts as a dual molecular switch by which the target efficacies of two existing and safe medications are perfectly fine-tuned to effectively treat the disease. Using a proprietary formulation, JM-010 targets central mechanisms underlying the development of dyskinesia in Parkinson’s disease. JM-010 has successfully demonstrated its efficacy and safety in preclinical studies, as well as in Phase I clinical safety and Phase II clinical proof of concept studies. Currently, JM-010 is undergoing Phase II clinical studies in Europe and US.

NLX 112: Neurolixis NLX-112 (also known as befiradol or F13640) is a novel compound that activates serotonin 5-HT1A receptors. NLX-112 has two main advantages over older compounds: NLX-112 is extremely selective for the 5-HT1A receptor, with over 1000-fold selectivity compared to other types of receptor types, and NLX-112 is a full agonist at 5-HT1A receptors, maximally activating the receptor. Currently, the drug is in Phase II stage of clinical trial evaluation for the treatment of L-DOPA-induced dyskinesia in Parkinson'sdisease.

CPL 500036: Celon Pharma CPL500-036 is a novel PDE10A inhibitor developed in laboratories of Celon Pharma S.A. It is characterized by high in vitro and in vivo potency, it is highly selective and has good oral bioavailability (F > 70%) and BBB penetration (B/P = 0,4) in rats. Several behavioural studies have confirmed its antipsychotic and precognitive action in rats (MED > 0,03 mg/kg). CPL500-036 is currently investigated in clinical trials. In October 2019 Celon Pharma S.A. completed a phase I clinical trial for CPL500-036. Currently, the drug is in Phase II stage of clinical trial evaluation for the treatment ofMedication-Induceddyskinesia.

ETH42: Ethris Ethris is developing ETH42 to address the genetic cause of the disease primary ciliary dyskinesia (PCD). ETH42 is a first-in-class LNP formulated m RNA encoding CCDC40, a structural protein involved in the motor machinery of motile cilia. The product candidate is intended for patients with CCDC40 mutations. Preclinical pharmacology studies demonstrate that treatment with ETH42 restores normal cilia structure and function. The drug is currently being explored in preclinical studies for primary ciliarydyskinesia(PCD).

Dyskinesia: Therapeutic Assessment

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

Major Players in Dyskinesia

There are approx. 20+ key companies which are developing the therapies for Dyskinesia. The companies which have their Dyskinesia drug candidates in the most advanced stage, i.e. phase II include, Contera Pharma.

Phases

This report covers around 22+ 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

Dyskinesia 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.

Dyskinesia: Pipeline Development Activities

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

Dyskinesia Report Insights

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

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

Key Players

• Contera Pharma
• Ethris
• Neurolixis
• Celon Pharma
• Addex Pharma S.A.
• VistaGen Therapeutics, Inc.
• Re CodeTherapeutics
• LuyePharma Group
• SOM3366
• Integrative Research Laboratories
• Parion Sciences
• Sumitomo Pharma
• Neurocrine Biosciences
• CYCLE Pharmaceuticals

Key Products

• JM-010
• CP011
• NLX-112
• CPL 500036
• ETH42
• Dipraglurant
• AV-101
• RCT1100
• ETH44
• LPM3770164
• SOM3366
• Mesdopetam
• Idrevloride
• DSP 9632 P

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