#1 Clinical Trials Search in Europe

Ladarixin

Ladarixin is an investigational drug being studied in clinical trials for its potential benefits in treating type 1 diabetes and certain cancers. This article summarizes key information from several clinical trials examining the safety and efficacy of ladarixin in different patient populations and disease contexts.

Table of Contents

What is Ladarixin?

Ladarixin, also known as LDX, is an experimental drug that is being studied for its potential to treat various medical conditions, primarily type 1 diabetes and certain types of cancer[1][2][3]. It belongs to a class of drugs called CXCR1/CXCR2 inhibitors, which means it blocks specific receptors in the body that are involved in inflammation and immune responses[4].

How Ladarixin Works

Ladarixin works by targeting and blocking two types of receptors in the body called CXCR1 and CXCR2. These receptors are involved in the body’s inflammatory response and play a role in various diseases. By blocking these receptors, Ladarixin may help reduce inflammation and protect certain cells in the body from damage[4].

In type 1 diabetes, Ladarixin is thought to help protect the insulin-producing beta cells in the pancreas from being destroyed by the body’s immune system. This could potentially slow down the progression of the disease and help patients maintain better control of their blood sugar levels[2].

Conditions Treated with Ladarixin

Ladarixin is currently being studied for the following conditions:

  • Type 1 Diabetes: This is the primary focus of most clinical trials. Researchers are investigating whether Ladarixin can help preserve the function of insulin-producing cells in people newly diagnosed with type 1 diabetes[2][4].
  • Advanced Non-Small Cell Lung Cancer (NSCLC): Ladarixin is being studied in combination with another drug called Sotorasib for patients with a specific type of lung cancer that has a mutation in the KRAS gene[3].

Clinical Trials and Research

Several clinical trials are currently underway to evaluate the effectiveness and safety of Ladarixin:

  • Type 1 Diabetes Trials: Multiple studies are looking at how Ladarixin affects newly diagnosed type 1 diabetes patients. These trials are measuring things like blood sugar control, insulin requirements, and the function of insulin-producing cells[2][4][5].
  • Cancer Trial: A phase I/II study is investigating the combination of Ladarixin with Sotorasib in patients with advanced lung cancer that has a specific genetic mutation[6].
  • Food Effect Study: One study looked at how food affects the way the body absorbs and processes Ladarixin[1].

How Ladarixin is Administered

In most clinical trials, Ladarixin is given as an oral medication in the form of capsules. The typical dose being studied is 400 mg taken twice a day, usually in the morning and evening. Some studies are using a cyclical dosing schedule, where patients take the medication for 14 days, then have a 14-day break before starting again[4][5].

Potential Side Effects

As Ladarixin is still in the research phase, all of its potential side effects are not yet known. The clinical trials are carefully monitoring patients for any adverse events. Some trials are specifically looking at the risk of severe low blood sugar (hypoglycemia) in diabetes patients taking Ladarixin[5].

Future Research and Potential

Ladarixin is still in the early stages of research, and more studies are needed to fully understand its effectiveness and safety. If the current trials show promising results, it could lead to larger studies and potentially become a new treatment option for type 1 diabetes or certain types of cancer in the future. However, it’s important to remember that many experimental drugs do not make it through all stages of clinical trials, so more research is needed before Ladarixin could become an approved medication[6][5].

Aspect Details
Drug Name Ladarixin (LDX)
Mechanism of Action Inhibitor of CXCR1 and CXCR2 receptors
Main Conditions Studied Type 1 Diabetes, Advanced Non-small Cell Lung Cancer with KRAS G12C Mutation
Dosage in Trials Typically 400 mg twice daily, often in cycles of 14 days on/14 days off
Key Outcomes Measured C-peptide levels, HbA1c, insulin requirements, time in glucose range (for diabetes); Progression-free survival (for cancer)
Safety Monitoring Adverse events, serious adverse events, hypoglycemic episodes
Trial Phases Phase 1, Phase 2
Patient Populations Newly diagnosed T1D patients, overweight insulin-resistant T1D patients, advanced NSCLC patients
Combination Therapies With insulin (for diabetes), with sotorasib (for cancer)

FAQ

  • What is Ladarixin? Ladarixin is an investigational drug that acts as an inhibitor of CXCR1 and CXCR2 receptors. It is being studied for its potential to preserve beta-cell function in type 1 diabetes and as a combination therapy for certain cancers.
  • What conditions is Ladarixin being studied for? Ladarixin is primarily being studied for type 1 diabetes, particularly in newly diagnosed patients. It is also being investigated as a combination therapy with sotorasib for advanced non-small cell lung cancer with KRAS G12C mutation.
  • How is Ladarixin administered in clinical trials? In most trials, Ladarixin is administered orally as capsules, typically at a dose of 400 mg twice daily. Some trials use cycles of 14 days on treatment followed by 14 days off.
  • What are the main outcomes being measured in Ladarixin trials? For diabetes trials, key outcomes include changes in C-peptide levels, HbA1c levels, insulin requirements, and time in target blood glucose range. For cancer trials, progression-free survival and safety are primary outcomes.
  • Are there any known side effects of Ladarixin? The trials are ongoing and full safety data is not yet available. The studies are monitoring for adverse events and serious adverse events to assess the safety profile of Ladarixin.

Ongoing Clinical Trials on Ladarixin

  • Study of the efficacy and safety of ladarixin and rabbit anti-human thymocyte immunoglobulin in adolescents and adults with new-onset type 1 diabetes

    Not yet recruiting

    1 1
    Investigated drugs:
    Italy

  • Study on the Effects and Safety of Ladarixin for Adults and Adolescents with Recent Onset Type 1 Diabetes

    Not recruiting

    1
    Investigated drugs:
    Belgium Germany Italy

Glossary

  • Ladarixin: An investigational drug that inhibits CXCR1 and CXCR2 receptors, being studied for its potential benefits in type 1 diabetes and certain cancers.
  • Type 1 Diabetes (T1D): An autoimmune condition where the body's immune system attacks and destroys insulin-producing beta cells in the pancreas, leading to high blood sugar levels.
  • C-peptide: A substance produced along with insulin by pancreatic beta cells. Its levels in the blood indicate how much insulin the body is producing.
  • HbA1c: Glycated hemoglobin, a measure of average blood sugar levels over the past 2-3 months. Used to diagnose diabetes and monitor blood sugar control.
  • Mixed Meal Tolerance Test (MMTT): A test used to assess beta-cell function by measuring C-peptide levels after consuming a standardized meal.
  • Continuous Glucose Monitoring (CGM): A method to track glucose levels throughout the day and night using a sensor inserted under the skin.
  • Time in Range (TIR): The percentage of time a person's blood glucose levels are within a target range, typically 70-180 mg/dL for most people with diabetes.
  • KRAS G12C Mutation: A specific genetic mutation found in some cancers, particularly non-small cell lung cancer, which can affect treatment response.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.

References

  1. https://clinicaltrials.gov/study/NCT04854642
  2. https://clinicaltrials.gov/study/NCT05035368
  3. https://clinicaltrials.gov/study/NCT05815186
  4. https://clinicaltrials.eu/trial/study-on-the-effects-and-safety-of-ladarixin-for-adults-and-adolescents-with-recent-onset-type-1-diabetes/
  5. https://clinicaltrials.gov/study/NCT04899271
  6. https://clinicaltrials.gov/study/NCT05815173