Omeros Finalizes Clinical Plan For Kidney Disease Treatment, Reports Additional Positive Phase 2 Data

Omeros Corporation OMER shares are seeing buying interest Thursday following a clinical update on its lead human monoclonal antibody OMS721, which is being evaluated for IgA nephropathy.

What Happened

IgA nephropathy is a kidney disease resulting from the accumulation of an antibody called immunoglobin A in the kidney, which causes inflammation and in turn impacts the ability of the kidney to filter wastes from blood.

Following a meeting with the FDA on the Phase 3 trial, Omeros said Thursday it has finalized its clinical plan for OMS721.

OMS721 targets MASP-2, the effector enzyme of the lectin pathway of the complement system. The company said the FDA agreed to extend the primary endpoint of the assessment of proteinuria from 24 weeks to 36 weeks to allow additional dosing if warranted. This allows a path to accelerated or full approval, either in the entire population or the high-risk population, according to Omeros. 

The FDA also agreed for allowing open-label treatment of the high-risk population only after at least one year of blinded treatment. The change in the trial design is viewed negatively by a few, including Stat biotech reporter Adam Feuerstein.

Two $OMER press releases now and nothing about promised BLA filing for ‘721 in HSCT-TMA. And today we learn the ‘721 Ph3 in IgAN required change in primary endpoint. Remember, ph2 data were poor. Crumbling.

— Adam Feuerstein (@adamfeuerstein) January 17, 2019

Omeros said the Phase 3 ARTEMIS-IGAN study for which enrollment is underway will incorporate the beneficial changes agreed to with the FDA without impacting the study patients already enrolled.

The biotech announced additional data from patients in the second cohort of the Phase 2 trial, which showed stable eGFR measurements and 61-percent median reduction in proteinuria from baseline. Five of the eight patients achieved greater than 50-percent proteinuria reductions, and across the first and second cohorts, nine of the 12 patients achieved greater than 50-percent reductions in proteinuria, the company said. 

Why It's Important

IgA nephropathy has no approved therapy. Omeros is also evaluating the asset for other kidney ailments such as stem-cell transplant associated TMA, atypical hemolytic uremic syndrome, lupus nephritis and other renal diseases.

"The data, together with the recently finalized registration plan, are further consistent with our expectations that the OMS721 Phase 3 ARTEMIS-IGAN trial will be successful, and we look forward to making the drug available to our patients," Richard Lafayette, chair of the OMS721 IgAN Academic Leadership Committee, said in a statement. 

What's Next

"We're confident in the effects seen with OMS721 and in our registration approach for the drug in IgA nephropathy, and we expect that it will likely follow stem-cell transplant TMA as the second approved indication for OMS721," Omeros CEO Gregory Demopulos said in a statement. 

Omeros shares were trading up by 1.35 percent at $13.10 at the time of publication Thursday.

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