Investors in Omeros Corporation (NASDAQ:OMER) should be smiling from ear to ear today after the drug maker announced positive data from its Phase 2 clinical trial of OMS721 for the treatment of kidney disorders. Statistical significance (p ≤ 0.017) was achieved on key endpoints of improvement in renal function.
Omeros shares reacted to the news, rising nearly 10% to $8.10 in early trading Monday.
Omeros also reported the outcome of a recent FDA meeting regarding breakthrough therapy designation for OMS721 in immunoglobulin A (IgA) nephropathy (also known as Berger’s disease). Based on that meeting, Omeros is pursuing FDA breakthrough therapy designation. In addition to the Phase 2 program in renal diseases, OMS721 is being evaluated in a Phase 3 program for patients with atypical hemolytic uremic syndrome (aHUS) and in a Phase 2 program for patients with thrombotic microangiopathies (TMAs), including hematopoietic stem cell transplant-associated TMAs and thrombotic thrombocytopenic purpura. 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.
Consistent with the other clinical trials with OMS721, no significant safety concerns have been observed. The most commonly reported adverse events in this trial have been anemia and fatigue, both commonly seen in these populations. Omeros plans to submit these data for presentation at the European Renal Association-European Dialysis Transplant Association 54th Annual Congress to be held in June 2017.
Given the data seen in these renal patients, Omeros discussed with the FDA’s Division of Cardiovascular and Renal Products the potential treatment effects and the possibility of a rapid and abbreviated path to approval. Based on the FDA’s guidance, Omeros is pursuing breakthrough therapy designation for OMS721 in IgA nephropathy and is amending the current protocol for its Phase 2 renal trial to assess five OMS721-treated and five placebo-treated patients with the disease. These patients need not be steroid-dependent, which is expected to greatly accelerate enrollment. Achieving statistical significance is not required. In parallel to completing the limited enrollment for breakthrough designation, Omeros plans to advance OMS721 rapidly through its IgA nephropathy development program to support both U.S. and international marketing authorizations. After additional OMS721 data have been collected in membranous nephropathy patients, Omeros may also pursue breakthrough therapy designation for that indication.
“While the patient numbers are small, the consistency in the patients’ clinical courses in these severe diseases is impressive,” stated Professor Michal Nowicki, President of the Polish Society of Nephrology and OMS721 clinical investigator. “The responses we have observed in patients with aHUS, including reversal of renal failure and dialysis cessation, and these renal data demonstrate the potential of lectin pathway inhibition in nephrology.”
Omeros’ Phase 3 OMS721 aHUS program continues to progress with Phase 3 enrollment planned to open late this year. The current TMA Phase 2 clinical trial continues steadily to enroll and treat aHUS patients, gathering data to support a biological license application (BLA). Omerosplans to submit aHUS data from this study for presentation at the International Society of Nephrology World Congress of Nephrology in April 2017. The OMS721 program also continues to support compassionate use in Europe and the FDA has approved OMS721 for compassionate use in the U.S.
“We are very excited about these additional data in serious renal diseases,” stated Gregory A. Demopulos M.D., chairman and chief executive officer of Omeros. “The Phase 3 clinical trial for aHUS is expected to open for enrollment later this year, and the clinical data from these IgA and membranous nephropathy patients increase the number of commercial avenues for OMS721. Current understanding of the importance of the lectin pathway’s role across inflammatory diseases is expanding, and we look forward to continuing to work with the FDA and international regulatory agencies to develop an efficient and rapid path to approval for OMS721 in the treatment of aHUS, IgA and membranous nephropathies and a number of other diseases.” (Original Source)
On the ratings front, Omeros has been the subject of a number of recent research reports. In a report issued on August 11, Wedbush analyst Liana Moussatos reiterated a Buy rating on OMER, with a price target of $56, which represents a potential upside of 663% from where the stock is currently trading. Separately, on August 10, Maxim Group’s Jason Kolbert reiterated a Buy rating on the stock and has a price target of $19.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Liana Moussatos and Jason Kolbert have a total average return of 12.1% and -15.9% respectively. Moussatos has a success rate of 41% and is ranked #224 out of 4180 analysts, while Kolbert has a success rate of 28% and is ranked #4076.
Overall, 4 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $38.33 which is 422% above where the stock closed last Friday.
Omeros Corp. engages in the development and commercialization of small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies, and disorders of the central nervous system. Its products are derived from its proprietary PharmacoSurgery platform designed to improve clinical outcomes of patients undergoing arthroscopic, ophthalmological, urological, and other surgical and medical procedures.