Omeros Corporation (NASDAQ:OMER) announced that extended follow-up data from patients with immunoglobulin A (IgA) nephropathy treated with OMS721 were presented on November 4, 2017 at the American Society of Nephrology (ASN) Meetingin New Orleans. These data describe up to one-year follow-up of patients treated with OMS721 in the glomerulonephropathy Phase 2 clinical trial. OMS721 is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system.
During the Phase 2 clinical trial, which consisted of 12 weeks of treatment and 6 weeks of follow-up, all patients with IgA nephropathy demonstrated clinically meaningful improvement in proteinuria. The data were statistically significant. These data, which are limited to the duration of the clinical trial, were previously presented at the 54th European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Congress in June 2017. The additional data presented at the ASN meeting over the weekend describe the course of these Phase 2 patients after the trial and while under usual care for up to approximately one year after completion of OMS721 treatment.
As previously reported, all four IgA nephropathy patients demonstrated a substantial reduction in proteinuria during the clinical trial, including 24-hour urine protein levels and albumin/creatinine ratios (uACRs). In the extended follow-up after completion of the Phase 2 trial, urine protein/creatinine ratios (uPCR) were measured according to investigator practice standard. For purposes of post-hoc comparisons of proteinuria during and after the clinical trial, each post-trial uPCR value was converted to uACR (Zhao, Clin J Am Soc Nephrol 2016;11:947-55).
Proteinuria reduction was maintained in three of the four patients. In these three patients, uACRs during extended follow-up remained decreased. Specifically, those three patients maintained partial remission relative to baseline during available follow-up (75.8%, 85.9%, and 76.8% uACR decreases at 12, 11, and 3 months after cessation of OMS721 dosing, respectively). Following a substantial drop in uACR during dosing and trial follow-up, the fourth patient’s uACR returned to approximately 88 percent of baseline at four months after the end of treatment with OMS721.
Numerical improvement in estimated glomerular filtration rate (eGFR), a measure of renal function, was observed in 3 of the 4 patients after the trial. Post-treatment eGFR increases ranged from 7 to 17 mL/min/1.73 m2 relative to screening values. The patient with the most severe reduction in kidney function demonstrated eGFR improvement from 30 mL/min/1.73 m2 to 47 mL/min/1.73 m2, an improvement of 57 percent. The fourth patient demonstrated stable eGFR relative to screening.
OMS721 was well-tolerated in the clinical trial with fatigue and anemia the most commonly reported adverse events. All adverse events were mild to moderate; some were considered possibly related but most were considered unrelated to OMS721. Following the clinical trial, all patients have remained well.
A Phase 3 clinical program for OMS721 in IgA nephropathy has been initiated and Omeros is finalizing a Phase 3 protocol with FDA. FDA has granted OMS721 both breakthrough and orphan designations in IgA nephropathy.
There is no approved treatment for IgA nephropathy, the most common primary glomerulopathy globally. The disease is responsible for up to 10 percent of all dialysis patients. In the U.S. alone, an estimated 120,000 to 180,000 patients have this disease. Up to 40 percent of IgA nephropathy patients develop end-stage renal disease, a life-threatening condition, within 20 years following diagnosis.
Shares of Omeros are currently trading at $14.51, down $0.43 or 2.85%. OMER has a 1-year high of $27.09 and a 1-year low of $8.71. The stock’s 50-day moving average is $19.26 and its 200-day moving average is $19.46.
On the ratings front, OMER stock has been the subject of a number of recent research reports. In a report issued on October 30, Maxim analyst Jason Kolbert reiterated a Buy rating on OMER, with a price target of $24, which implies an upside of 61% from current levels. Separately, on August 24, Cantor’s Elemer Piros reiterated a Hold rating on the stock.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Kolbert and Elemer Piros have a yearly average loss of -8.7% and a return of 2.9% respectively. Kolbert has a success rate of 35% and is ranked #4640 out of 4703 analysts, while Piros has a success rate of 48% and is ranked #1706.
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.