So what to make of Omeros Corporation’s (NASDAQ:OMER) latest success? This morning, the drug maker announced that it has reached an agreement with the FDA that available data from OMS721 supports the prospect for benefit in IgA nephropathy (IgAN) patients. Following the approval of the Phase 3 trial protocol, patient enrollment is expected to begin early next month.
Omeros shares reacted to the news, soaring nearly 8%, as of this writing.
Omeros CEO Gregory Demopulos commented, “We’re pleased to have received agreement from FDA for our OMS721 Phase 3 protocol in IgA nephropathy […] Final preparations to begin the trial can now be completed and enrollment is expected to open in early February. To our OMS721 Phase 3 programs in IgA nephropathy and aHUS, we have recently added a third Phase 3 program in stem cell transplant-associated TMA. We look forward to ongoing discussions with both FDA and EMA regarding the HCT-TMA Phase 3 trial as well as breakthrough and PRIME designations. In the meantime, enrollment in the Phase 2 HCT-TMA trial has progressed with patients expected to have a very high mortality rate doing well on OMS721.”
The single Phase 3 trial is a randomized, double-blind, placebo-controlled trial in patients at least 18 years of age with biopsy-confirmed IgAN and with 24-hour urine protein excretion greater than 1 g/day at baseline on optimized renin-angiotensin system (RAS) blockade. Patients will receive an initial 12 weekly intravenous doses of study drug; additional weekly dosing can be administered for partial responders and relapsers. The primary endpoint, which could suffice for full approval, is reduction in proteinuria at 24 weeks after the start of dosing. The trial will employ an adaptive design that will allow intra-trial adjustment in sample size. For purposes of safety and efficacy assessments, the initial sample size for the proteinuria endpoint is estimated at 140 patients in each of the treatment and placebo groups. This will include a subset of patients with high levels of proteinuria (i.e., equal to or greater than 2 g/day) at baseline, and full approval could also be obtained if a substantial improvement is seen at 24 weeks in this subset of patients alone. The trial design will allow assessment for either full or accelerated approval at 24 weeks based on proteinuria results either (1) across the general population of study patients or (2) in the high-proteinuria subset of patients. In the event that the primary endpoint at 24 weeks results in accelerated approval from FDA, change in estimated glomerular filtration rate (eGFR) will be assessed at approximately three years after the start of dosing. The initial sample size estimate for the eGFR endpoint is approximately 160 patients per group and also will be adjustable under the study’s adaptive design.
On the ratings front, Omeros has been the subject of a number of recent research reports. In a report issued on December 14, H.C. Wainwright analyst Ram Selvaraju reiterated a Buy rating on OMER, with a price target of $30, which implies an upside of 49% from current levels. On December 12, Maxim Group’s Jason Kolbert assigned a Buy rating to the stock and has a price target of $24.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Ram Selvaraju and Jason Kolbert have a yearly average loss of -16.7% and -5.6% respectively. Selvaraju has a success rate of 28% and is ranked #4676 out of 4727 analysts, while Kolbert has a success rate of 37% and is ranked #4602.
Omeros operates as a biopharmaceutical company committed to discovering, developing, and commercializing small-molecule and protein therapeutics for large market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system.