Omeros Schedules Webcast to Present Final Efficacy Results from Narsoplimab BLA for the Treatment of HSCT-TMA
-- Efficacy Results Surpass Those from Preliminary Analysis Previously Reported --
SEATTLE--(BUSINESS WIRE)-- Omeros Corporation (Nasdaq: OMER) today announced that the final results of its pivotal trial of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) will be presented in a webcast on Thursday, October 22, 2020 at 8:30 a.m. ET by Miguel Perales, M.D, Chief of the Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center, and Alessandro Rambaldi, MD, Professor, Department of Oncology and Hematology-Oncology at the University of Milan and Head of the Hematology and Bone Marrow Transplant Unit at ASST Papa Giovanni XXIII in Bergamo, Italy.
The data to be presented are from the final analyses included in the narsoplimab Biologics Licensing Application (BLA) being submitted to the U.S. Food and Drug Administration (FDA) for the treatment of HSCT-TMA. The primary efficacy endpoint of complete response rate, as well as the secondary endpoints of 100-day and median overall survival, were updated based on additional data collected to provide detailed patient narratives as requested by FDA during initial discussions regarding pivotal study design and endpoints. These updated data and analyses form the basis of regulatory review and product labeling. The BLA also includes data from the HSCT-TMA compassionate-use program, which are highly consistent with the clinical trial data. The safety profile observed in the final data set remains consistent with data previously presented.
To make the final data from the BLA first accessible to all members of the public at next week’s webcast discussion by Drs. Perales and Rambaldi, rather than only to registered conference participants attending today’s 4th Complement-based Drug Development Summit, the presentation that Dr. Whitaker was previously scheduled to give at today’s Summit has been replaced with a presentation by Jason Cummings, Ph.D., Associate Director of Research, on Omeros’ OMS906 MASP-3 inhibitor program today at 8:30 a.m. EDT.
To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 7876969. Please dial in approximately 10 minutes prior to the start of the call.
To access the live or subsequently archived webcast and presentation materials on the internet, click here or go to the company’s website at www.omeros.com and select “Events” under the Investors section of the website.
About Omeros Corporation
Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. In addition to its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros has multiple late-stage clinical development programs focused on complement-mediated disorders, including COVID-19, and substance abuse. A rolling biologics license application for narsoplimab, the company’s lead MASP-2 inhibitor, in hematopoietic stem cell transplant-associated thrombotic microangiopathy is being completed for submission to the U.S. FDA. Omeros also has a diverse group of preclinical programs including GPR174, a novel target in immuno-oncology that modulates a new cancer immunity axis recently discovered by Omeros. Small-molecule inhibitors of GPR174 are part of Omeros’ proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and their corresponding compounds. The company also exclusively possesses a novel antibody-generating platform.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the “safe harbor” created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “goal,” “intend,” “likely”, “look forward to,” “may,” “on track,” “plan,” “potential,” “predict,” “project,” “prospects,” “scheduled,” “should,” “slated,” “targeting,” “will,” “would” and similar expressions and variations thereof. Forward-looking statements, including statements regarding anticipated regulatory submissions, the timing and results of ongoing or anticipated clinical trials, and the therapeutic application of Omeros’ investigational product, are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. Omeros’ actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, availability and timing of data from clinical trials and the results of such trials, unproven preclinical and clinical development activities, regulatory oversight, intellectual property claims, competitive developments, litigation, and the risks, uncertainties and other factors described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission (SEC) on March 2, 2020, as supplemented by its Quarterly Report on Form 10-Q filed with the SEC on August 10, 2020 and subsequent filings with the SEC. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the company assumes no obligation to update these forward-looking statements, whether as a result of any new information, future events or otherwise, except as required by applicable law.
Jennifer Cook Williams
Cook Williams Communications, Inc.
Investor and Media Relations
Source: Omeros Corporation