aHUS trials watch 9

Article No. 318

13 February 2020

The alliance has reported on the development of OMS721 made by Omeros before. It is a potential drug therapy for aHUS  that has been around for a number of years but has not seemed to breakthrough. It is a monoclonal antibody that inhibits the MASP 2 component of the Lectin pathway of Complement.
Although Its manufacturers appear to show little interest in communating directly with aHUS patient organisations, indeed it does not provide links to any aHUS organisation on its patients’ sources page,the alliance, unlike the generic disease  sites it does cite, has kept a watch and interest for aHUS and Complement related TMA patients.
Omeros’s website information about its TMA pipeline can be seen Here.
On the ClinicalTrials.gov website Omeros’ first trial “A Phase 3 Study to Evaluate the Safety and Efficacy of OMS721 for the Treatment of Atypical Hemolytic Uremic Syndrome (aHUS) in Adults and Adolescents” is due to end this month. However as the trial site  has not been updated since 2018 ( see link above) it does not look hopeful that it has been conclusive. It is remarkable that after being open to recruitment for more than three years it is still designated as recruiting.
Having completed a phase 2 study of use in other TMAs i.e. those classified as Glomuleropathies including IgaN , Lupus , MN, C3G including DDD Omeros, has continued to explore these as possible indications for OMS721.
A study of IgaN alone had shown promise but some concerns have been expressed and the trial is on going and recruiting and not due to be completed until 2023.
A more generic TMA study which begun in 2014  reached its estimated completion date in December 2019. Nothing heard so far but under another “trial” it is available still for compassionate use ,including for aHUS click here 
Last month ( January 2020) Omeros announced a trial of a drug called Narsoplimab for use in the treatment of HSCT- TMA , a thrombotic microangiopathy that can occur following a stem cell bone marrow transplant.
Narsoplimab is the name now given to OMS721. It can be administered by infusion or subcutaneously.   Nothing is still yet known about how affordable it might be.

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