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Oms906

OMS906 is an investigational drug currently being studied in clinical trials for the treatment of rare blood and kidney disorders. These trials aim to evaluate the safety, efficacy, and potential benefits of OMS906 in patients with conditions such as Paroxysmal Nocturnal Hemoglobinuria (PNH), C3 Glomerulopathy (C3G), and Idiopathic Immune Complex-Mediated Glomerulonephritis (ICGN). The ongoing research seeks to determine if OMS906 can improve symptoms and quality of life for patients with these challenging diseases.

Table of Contents

What is OMS906?

OMS906 is a new investigational drug being studied for its potential to treat several rare diseases related to the body’s complement system[1]. The complement system is part of our immune defense, but when it malfunctions, it can cause serious health problems. OMS906 works by targeting a specific part of this system called Complement Factor D (CFD), which plays a crucial role in regulating immune responses[2].

What conditions does OMS906 treat?

OMS906 is being investigated for several rare diseases, including:

  • C3 Glomerulopathy (C3G): A group of rare kidney diseases where the complement system attacks the kidneys, leading to inflammation and damage[1].
  • Idiopathic Immune Complex-Mediated Glomerulonephritis (ICGN): Another rare kidney disorder where the immune system mistakenly attacks the kidneys[1].
  • Paroxysmal Nocturnal Hemoglobinuria (PNH): A rare blood disorder where red blood cells break down faster than they should, leading to various complications including anemia (low red blood cell count)[2][3][4].

How is OMS906 administered?

OMS906 is given to patients in different ways, depending on the specific clinical trial:

  • Intravenous (IV) infusion: The drug is injected directly into a vein. This method is used in several trials, with doses ranging from 3 mg/kg to 5 mg/kg, given every 4 or 8 weeks[1][2][4].
  • Subcutaneous (SC) injection: The drug is injected just under the skin. One trial is testing this method with a dose of 5 mg/kg given every 4 weeks[3].

Current Clinical Trials

Several clinical trials are currently underway to test OMS906:

  • A Phase 2 study for C3G and ICGN patients[1].
  • A long-term safety and efficacy study for PNH patients[2].
  • A Phase 1b study for PNH patients[3].
  • A study for PNH patients who haven’t responded well to another drug called ravulizumab[4].

Safety and Efficacy

The primary goal of these trials is to assess the safety and tolerability of OMS906. Researchers are closely monitoring for any side effects or adverse reactions[1][2][3][4].

The trials are also looking at how effective OMS906 is in treating these conditions. They’re measuring things like:

  • Changes in protein levels in urine (for kidney diseases)[1]
  • Improvements in hemoglobin levels (for PNH)[2][3][4]
  • Reduction in the need for blood transfusions[2][3][4]
  • Changes in levels of lactate dehydrogenase (LDH), an indicator of red blood cell breakdown[2][3][4]

Future Prospects

While OMS906 is still in the testing phase, it shows promise for patients with these rare diseases. If the clinical trials are successful, it could provide a new treatment option for people who currently have limited choices[1][2][3][4].

It’s important to note that OMS906 is still an experimental drug. More research is needed to fully understand its benefits and potential risks. Patients interested in this treatment should discuss it with their healthcare providers and consider participating in clinical trials if eligible.

Aspect Details
Drug Name OMS906
Conditions Studied Paroxysmal Nocturnal Hemoglobinuria (PNH), C3 Glomerulopathy (C3G), Idiopathic Immune Complex-Mediated Glomerulonephritis (ICGN)
Administration Intravenous (IV) or Subcutaneous (SC) injections
Dosing 3-5 mg/kg at 4-8 week intervals
Primary Objectives Safety and tolerability assessment
Secondary Objectives Efficacy, pharmacokinetics, pharmacodynamics
Key Outcome Measures Hemoglobin levels, LDH levels, proteinuria, kidney function, transfusion requirements
Study Designs Open-label, uncontrolled, fixed-dose studies
Study Duration Varies, with assessments typically at 24 and 48 weeks, some with long-term extensions

FAQ

  • What is OMS906? OMS906 is an investigational drug being studied for the treatment of rare blood and kidney disorders. It is administered intravenously or subcutaneously at specific intervals, depending on the study and condition being treated.
  • What conditions is OMS906 being tested for? OMS906 is currently being tested in clinical trials for Paroxysmal Nocturnal Hemoglobinuria (PNH), C3 Glomerulopathy (C3G), and Idiopathic Immune Complex-Mediated Glomerulonephritis (ICGN).
  • How is OMS906 administered in these clinical trials? In the trials, OMS906 is administered either intravenously (IV) or subcutaneously (SC) at intervals ranging from 4 to 8 weeks, with doses typically around 3-5 mg/kg, depending on the specific study.
  • What are the main goals of these clinical trials? The main goals of these trials are to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of OMS906 in patients with the targeted conditions. Researchers are looking at how well the drug is tolerated and if it improves symptoms or markers of disease activity.
  • How long do these clinical trials last? The duration of the trials varies, but many of them assess outcomes at 24 and 48 weeks, with some studies extending to long-term follow-up periods to evaluate the drug's safety and efficacy over time.

Ongoing Clinical Trials on Oms906

  • Study on the Safety and Effects of OMS906 for Patients with C3 Glomerulopathy and Idiopathic Immune Complex-Mediated Glomerulonephritis

    Not recruiting

    2 1 1
    Investigated drugs:
    Lithuania Poland

  • Study on the Long-Term Safety and Effects of OMS906 for Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)

    Not recruiting

    2 1 1
    Investigated drugs:
    Germany

Glossary

  • Paroxysmal Nocturnal Hemoglobinuria (PNH): A rare blood disorder where red blood cells break down earlier than they should, leading to various complications including anemia and blood clots.
  • C3 Glomerulopathy (C3G): A group of rare kidney diseases characterized by the buildup of C3 protein in the kidneys, which can lead to kidney damage and failure.
  • Idiopathic Immune Complex-Mediated Glomerulonephritis (ICGN): A kidney disorder caused by the deposition of immune complexes in the glomeruli, leading to inflammation and potential kidney damage.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Pharmacodynamics (PD): The study of how a drug affects the body, including its mechanism of action and biochemical and physiological effects.
  • Intravenous (IV): A method of administering medication directly into a vein.
  • Subcutaneous (SC): A method of administering medication under the skin.
  • Hemoglobin (Hgb): A protein in red blood cells that carries oxygen throughout the body.
  • Lactate Dehydrogenase (LDH): An enzyme found in many body tissues; elevated levels can indicate cell damage or disease.
  • Anti-drug Antibodies (ADA): Antibodies produced by the immune system in response to a therapeutic drug, which can potentially affect the drug's efficacy or safety.
  • Complement Factor D (CFD): An enzyme involved in the complement system, which is part of the body's immune defense.
  • Glomerular Filtration Rate (eGFR): A measure of how well the kidneys are filtering waste from the blood.
  • Proteinuria: The presence of excess proteins in the urine, which can be a sign of kidney disease.

References

  1. https://clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-oms906-for-patients-with-c3-glomerulopathy-and-idiopathic-immune-complex-mediated-glomerulonephritis/
  2. https://clinicaltrials.gov/study/NCT06298955
  3. https://clinicaltrials.gov/study/NCT05889299
  4. https://clinicaltrials.gov/study/NCT05972967