In short
OM336 is an investigational protein-based medicine being studied to help immunized patients with end-stage renal failure become eligible for kidney transplantation. It is given as a subcutaneous injection and is currently in a Phase 2 clinical trial with 6 participants. The trial measures safety, tolerability, and changes in vPRA levels, which indicate how sensitized a patient's immune system is to potential donor kidneys.
Key points
- OM336 is an investigational protein-based substance with no marketing authorisation.
- It is being tested in a Phase 2 trial for end-stage renal failure patients awaiting kidney transplant.
- The trial has 6 participants and is currently authorised.
- OM336 is given by subcutaneous injection at a dose of 60 mg.
- The main outcomes are safety and tolerability and changes in vPRA levels at week 24.
- The study runs over a 6-month period in patients with chronic kidney disease awaiting a renal allograft.
What is OM336?
OM336 is a protein-based substance of the type classified as "Protein - Other" in the registry. It is an investigational medicine, meaning it has no marketing authorisation in the product records. The substance is supplied by Ouro Medicines Limited and appears only under the name OM336. In the single registered trial, OM336 is the substance being tested (the "Test" role).
How does OM336 work?
The registry records do not describe the molecular target or mechanism of action of OM336. What the trial measures gives a clue: the co-primary endpoint is the change in vPRA levels, where vPRA stands for virtual panel reactive antibody. vPRA estimates how many potential donor kidneys a patient's immune system would react against. The trial is designed to see whether OM336 affects HLA sensitization, which is the process by which a patient develops antibodies against human leukocyte antigens (HLA) from previous exposures such as transfusions, pregnancies, or transplants. A reduction in vPRA would suggest that OM336 may reduce the barrier to finding a compatible donor kidney.
Which conditions is OM336 studied for?
- End-stage renal failure — the trial includes patients with chronic kidney disease who are awaiting a renal allograft (a kidney transplant from a donor). These patients are immunized, meaning their immune system has developed antibodies that make it harder to find a compatible donor kidney.
How is OM336 given?
OM336 is prepared as a solution for injection and is given by subcutaneous injection, which means it is injected under the skin. In the registered trial, the dose is 60 mg. The other medicines listed in the trial — paracetamol, valaciclovir, dexamethasone, and diphenhydramine — are given orally as supporting or comparison treatments, not as the studied substance.
What do the clinical trials show?
There is one registered clinical trial of OM336 in the EU Clinical Trials Information System. It is a Phase 2 interventional study with 6 participants, currently in the authorised status. The trial evaluates the safety and tolerability of OM336 through week 24, and as a co-primary endpoint it measures vPRA levels at week 24. The study runs over a 6-month period in chronic kidney disease patients awaiting a renal allograft.
What does the trial measure?
The primary outcome is the assessment of the safety and tolerability of OM336 through week 24. The co-primary endpoint is the assessment of vPRA levels at week 24, which measures the degree of HLA sensitization.
Who can take part?
The trial enrols patients with end-stage renal failure who are immunized and awaiting a kidney transplant. The small size of 6 participants reflects an early-stage study focused on safety and biological effect.
What side effects are known?
No side effect data for OM336 are provided in the registry records or supplementary sources. Because the trial is still in an early phase and has not reported results, the safety profile of OM336 is not yet established.