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H-L-Tryphophanyl-L-Seryl-Glycyl-L-Tryptophanyl-L-Seryl-L-Seryl-L-Cysteinyl-L-Seryl-L-Arginyl-L-Seryl-L-Cysteinyl-Glycyl-Oh (Disulfide Bond), Acetate Salt

This article discusses the ongoing clinical trials of NX210c, a synthetic peptide drug being studied as a potential treatment for Amyotrophic Lateral Sclerosis (ALS). The trials aim to assess the drug’s efficacy, safety, tolerability, and pharmacokinetics in adult patients with ALS. The study focuses on evaluating the effects of NX210c on various biomarkers, functional capacities, and disease progression in ALS patients.

Table of Contents

What is NX210c?

NX210c is a new medication being studied for the treatment of Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig’s disease. It is a synthetic peptide, which means it’s a small protein-like molecule created in a laboratory[1]. The full chemical name of NX210c is quite complex: H-L-TRYPHOPHANYL-L-SERYL-GLYCYL-L-TRYPTOPHANYL-L-SERYL-L-SERYL-L-CYSTEINYL-L-SERYL-L-ARGINYL-L-SERYL-L-CYSTEINYL-GLYCYL-OH (DISULFIDE BOND), ACETATE SALT[1].

Purpose of the Study

Researchers are conducting a Phase II clinical trial to evaluate how well NX210c works and how safe it is for people with ALS[1]. This study, called SEALS (Safety and Efficacy of ALS Study), aims to determine if NX210c can help slow down the progression of ALS and improve the quality of life for patients.

How NX210c Works

While the exact mechanism is not fully explained in the study details, NX210c is designed to target certain aspects of ALS. The researchers are particularly interested in its effects on:

  • Neurofilament light chain (NfL): A protein that can be measured in blood and spinal fluid, which may indicate the rate of nerve cell damage[1].
  • Blood-Brain Barrier (BBB) integrity: The BBB is a protective barrier that separates the brain from the bloodstream. In ALS, this barrier may be compromised[1].
  • Neuroinflammation: Inflammation in the nervous system, which is thought to play a role in ALS progression[1].
  • Neuronal and synaptic transmission: How nerve cells communicate with each other, which is affected in ALS[1].

Eligibility Criteria

To participate in this study, patients must meet certain criteria, including:

  • Be 18 years or older[1]
  • Have a diagnosis of ALS according to specific criteria[1]
  • Have had ALS symptoms for 36 months or less[1]
  • Have a certain level of lung function (measured by something called Slow Vital Capacity or SVC)[1]
There are also several conditions that would prevent someone from participating, such as certain medical conditions or recent participation in other drug trials[1].

Study Objectives

The main goals of this study are to:

  1. Measure the effect of NX210c on neurofilament light chain levels in blood and spinal fluid[1]
  2. Assess how NX210c affects the integrity of the blood-brain barrier[1]
  3. Evaluate the impact of NX210c on ALS symptoms and disease progression[1]
  4. Determine if NX210c affects survival in ALS patients[1]
  5. Assess the safety and tolerability of NX210c[1]

Potential Benefits

If successful, NX210c could potentially:

  • Slow down the progression of ALS[1]
  • Improve functional capacities in ALS patients[1]
  • Enhance the quality of life for people living with ALS[1]
  • Potentially extend survival time for ALS patients[1]
However, it’s important to note that these potential benefits are still being studied and are not guaranteed.

Safety and Side Effects

As with any new medication, safety is a crucial concern. The study will closely monitor for any side effects or adverse reactions to NX210c. Participants will undergo regular check-ups, including physical examinations, blood tests, and other assessments to ensure their safety throughout the trial[1].

It’s important to remember that NX210c is still in the research phase. While it shows promise, more studies are needed to fully understand its effectiveness and safety profile in treating ALS.

Aspect Details
Drug Name NX210c (H-L-Tryphophanyl-L-Seryl-Glycyl-L-Tryptophanyl-L-Seryl-L-Seryl-L-Cysteinyl-L-Seryl-L-Arginyl-L-Seryl-L-Cysteinyl-Glycyl-Oh (Disulfide Bond), Acetate Salt)
Trial Phase Phase II
Condition Studied Amyotrophic Lateral Sclerosis (ALS)
Main Objectives Assess effects on blood NfL and blood-brain barrier integrity biomarkers
Secondary Objectives Evaluate effects on functional capacities, disease progression, survival, and quality of life
Administration Intravenous infusions
Maximum Dose 10 mg/kg daily, 120 mg/kg total over 4 months
Key Measurements Blood and CSF biomarkers, ALSFRS-R, SVC, muscle strength, disease progression rate, quality of life
Eligibility Adults with ALS diagnosis, disease duration ≤36 months, specific lung function capacity

FAQ

  • What is NX210c and what is it being studied for? NX210c is a synthetic peptide drug that is being studied as a potential treatment for Amyotrophic Lateral Sclerosis (ALS). It is currently undergoing Phase II clinical trials to assess its efficacy, safety, tolerability, and how it moves through the body (pharmacokinetics) in adult patients with ALS.
  • What are the main objectives of the NX210c clinical trial? The main objectives of the trial are to assess the effect of NX210c on blood neurofilament light chain (NfL) levels and on biomarkers of blood-brain barrier integrity. The study also aims to evaluate the drug's impact on functional capacities, disease progression, survival, and quality of life in ALS patients.
  • Who is eligible to participate in this clinical trial? Eligible participants are adults (18 years or older) diagnosed with ALS according to specific criteria, with disease duration of 36 months or less. They must have certain lung function capacity and be able to provide informed consent. There are additional criteria related to weight, pregnancy status, and contraception use.
  • How is NX210c administered in the trial? NX210c is administered through intravenous infusions. The maximum daily dose is 10 mg/kg, with a maximum total dose of 120 mg/kg over a treatment period of up to 4 months.
  • What are some of the key measurements being taken during the trial? The trial measures changes in blood and cerebrospinal fluid biomarkers, functional capacity using the ALS Functional Rating Scale-Revised (ALSFRS-R), lung function (Slow Vital Capacity), muscle strength, disease progression rate, and quality of life. It also monitors for any adverse events and assesses the pharmacokinetics of NX210c in a subset of patients.

Ongoing Clinical Trials on H-L-Tryphophanyl-L-Seryl-Glycyl-L-Tryptophanyl-L-Seryl-L-Seryl-L-Cysteinyl-L-Seryl-L-Arginyl-L-Seryl-L-Cysteinyl-Glycyl-Oh (Disulfide Bond), Acetate Salt

  • Study on the Effects of NX210c and Glucose in Adults with Amyotrophic Lateral Sclerosis (ALS)

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • Amyotrophic Lateral Sclerosis (ALS): A progressive nervous system disease that affects nerve cells in the brain and spinal cord, causing loss of muscle control.
  • Neurofilament light chain (NfL): A protein found in nerve cells that can be measured in blood or cerebrospinal fluid and is used as a biomarker for nerve damage in various neurological conditions.
  • Blood-Brain Barrier (BBB): A protective barrier that separates the brain from the bloodstream, controlling what substances can enter the brain.
  • Cerebrospinal Fluid (CSF): A clear, colorless fluid that surrounds the brain and spinal cord, protecting them and providing nutrients.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • ALSFRS-R: Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised, a tool used to measure the functional status of ALS patients.
  • Slow Vital Capacity (SVC): A measure of lung function that assesses the maximum amount of air a person can slowly exhale after taking a deep breath.
  • Biomarker: A measurable indicator of a biological state or condition, often used to track disease progression or treatment effects.
  • Lumbar Puncture: A medical procedure where a needle is inserted into the lower back to collect cerebrospinal fluid for testing.
  • El Escorial Revised criteria: A set of diagnostic criteria used to classify the certainty of ALS diagnosis in patients.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-of-nx210c-and-glucose-in-adults-with-amyotrophic-lateral-sclerosis-als/