The Phase 2 protocol provides for patients to receive weekly OMS721 treatments for four or eight weeks, at the discretion of the investigator.
To be eligible for enrollment, HCT-TMA patients are required to be adults with post-transplant TMA persisting at least two weeks following calcineurin inhibitor modification (conservative treatment).
A total of 14 HCT-TMA patients have been enrolled to date in the ongoing Phase 2 study. Eight patients have completed the protocol-specified treatment.
Four patients either withdrew consent or were discontinued by the investigator after two to three weeks of treatment with OMS721.
Three of the four patients for whom OMS721 treatment was discontinued early experienced deterioration of their conditions and subsequently died; the other patient, per protocol, was not followed and disposition is unknown.
Two other patients are currently receiving OMS721 treatment.
Substantial and statistically significant improvements in markers of TMA activity, specifically mean platelet count, mean lactate dehydrogenase, and mean haptoglobin were seen in this expanded number of study patients.
OMS721 has been well tolerated and no safety concerns have been identified. The most commonly reported adverse events were diarrhea and nausea.
While Omeros collects additional data through continued enrollment of the Phase 2 TMA study, the company is preparing to initiate an OMS721 Phase 3 clinical trial in patients with HCT-TMA.
Omeros is committed to discovering, developing and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies, and disorders of the central nervous system.
It has multiple Phase 3 and Phase 2 clinical-stage development programs focused on complement-associated thrombotic microangiopathies, complement-mediated glomerulonephropathies, Huntington's disease and cognitive impairment, and addictive and compulsive disorders.
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