Omeros Corporation (NASDAQ:OMER) announced about a week ago that it managed to complete its clinical plan for submission and approval of OMS721 after meeting with the FDA.
The announcement revealed that the company recently held a meeting with the U.S Food and Drug Administration, after which it completed OMS721 submission and approval clinical plan. Omero is seeking OMS721 submission and approval for immunoglobulin A nephropathy (IgAN). OMS721 is the company’s leading human monoclonal antibody which targets effector enzyme called MASP-2 in the lectin pathway. IgA nephropathy does not currently have any approved treatments.
The FDA received some of IgAN’s phase 2 clinical trial results as part of the material that was handed over during the meeting. The FDA meeting confirmed the extension of proteinuria’s phase 3 clinical trial’s primary endpoint from 24 to 36 weeks. The extension was issued after the company requested it along with extra OMS721 dosage if necessary.
OMS721 will be allowed open-label treatment but only after a minimum of one year of blinded treatment. This development is in response to the concerns expressed by investigators about extended OMS721 treatment withholding especially in high-risk study patients.
Omeros to sign up more patients in preparation for the OMS721 Phase 3 ARTEMIS-IGAN trials
Omeros plans to continue enrolling more patients in its OMS721 Phase 3 ARTEMIS-IGAN trials. However, it plans to do so without affecting the patients that are already enrolled in the study. The company will base the Phase 3 OMS721 clinical trials on the positive results that it collected from the Phase 2 cohorts.
“The data from the Phase 2 study continue to show a consistent and significant drug effect, the magnitude of which is unparalleled,” stated Professor Richard Lafayette who is the chairman of the OMS721 IgAN Academic Leadership Committee.
Professor Lafayette also pointed out that “Nephrologists target long-term kidney survival. He added that OMS721’s observed effects on eGFR and proteinuria are the results that the company expects to see. Omeros expects positive results from the OMS721 Phase 3 ARTEMIS-IGAN trial based on the consistent results that the firm has already seen in previous clinical trials.