NOVATO -
Setrusumab is a monoclonal antibody in development for the treatment of Osteogenesis Imperfecta (OI), a rare disease affecting approximately 60,000 individuals in the US and
Ultragenyx will present the latest results from the previously presented ASTEROID study and an overview of the design of the ongoing global, seamless Phase 2/3 Orbit study at the meeting. Data will also be presented from the
About Setrusumab (UX143)
Setrusumab is a fully human monoclonal antibody that inhibits sclerostin, a protein that acts on a key bone-signaling pathway that inhibits the activity of bone-forming cells. The goal of blocking inhibitory effects of sclerostin is to increase new bone formation, bone mineral density, and bone strength. Sclerostin inhibition also reduces excessive bone resorption, further enhancing its impact on bone density. In various mouse models of OI, the use of anti-sclerostin antibodies was shown to stimulate bone formation, improve bone mass and density, and reduce bone fragility as reflected in increased long bone strength and reduced the number of fractures.
Ultragenyx and Mereo are collaborating on the development of setrusumab globally based on the collaboration and license agreement between the parties. The companies are planning a comprehensive late-stage program to continue development of setrusumab in pediatric and young adult patients across OI sub-types I, III and IV.
About Ultragenyx
Ultragenyx is a biopharmaceutical company committed to bringing novel products to patients for the treatment of serious rare and ultra-rare genetic diseases. The company has built a diverse portfolio of approved therapies and product candidates aimed at addressing diseases with high unmet medical need and clear biology for treatment, for which there are typically no approved therapies treating the underlying disease.
The company is led by a management team experienced in the development and commercialization of rare disease therapeutics. Ultragenyx's strategy is predicated upon time- and cost-efficient drug development, with the goal of delivering safe and effective therapies to patients with the utmost urgency.
About
Mereo's lead oncology product candidate, etigilimab (anti-TIGIT), is currently in an open label Phase 1b/2 basket study evaluating anti-TIGIT in combination with an anti-PD-1 in a range of tumor types including three rare tumors and three gynecological carcinomas, cervical, ovarian, and endometrial carcinomas. The Company's second oncology product, navicixizumab, for the treatment of late line ovarian cancer, has completed a Phase 1 study and has been partnered with
Mereo Forward-Looking Statements
This press release contains 'forward-looking statements.' All statements other than statements of historical fact contained in this press release are forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended (the 'Securities Act'), and Section 21E of the United States Securities Exchange Act of 1934, as amended (the 'Exchange Act'). Forward-looking statements usually relate to future events and anticipated revenues, earnings, cash flows or other aspects of our operations or operating results. Forward-looking statements are often identified by the words 'believe,' 'expect,' 'anticipate,' 'plan,' 'intend,' 'foresee,' 'should,' 'would,' 'could,' 'may,' 'estimate,' 'outlook' and similar expressions, including the negative thereof. The absence of these words, however, does not mean that the statements are not forward-looking. These forward-looking statements are based on Mereo's current expectations, beliefs and assumptions concerning future developments and business conditions and their potential effect on Mereo. While management believes that these forward-looking statements are reasonable as and when made, there can be no assurance that future developments affecting Mereo will be those that it anticipates.
All of Mereo's forward-looking statements involve known and unknown risks and uncertainties, some of which are significant or beyond its control and assumptions that could cause actual results to differ materially from Mereo's historical experience and its present expectations or projections. You should carefully consider the foregoing factors and the other risks and uncertainties that affect Mereo's business, including those described in the 'Risk Factors' section of its latest Annual Report on Form 20-F, reports on Form 6-K and other documents furnished or filed from time to time by Mereo with the
Ultragenyx Forward-Looking Statements and Use of Digital Media
Except for the historical information contained herein, the matters set forth in this press release, including statements related to Ultragenyx's expectations and projections regarding its business plans and objectives, the therapeutic potential and clinical benefits of its product candidates, expectations regarding the safety and tolerability of its product candidates, and future clinical developments for its product candidates are forward-looking statements within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks and uncertainties that could cause the company's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the ability of the company to successfully develop UX143, the effects of the COVID-19 pandemic on the company's clinical activities, business and operating results, risks related to reliance on third party partners to conduct certain activities on Ultragenyx's behalf; the potential for any license or collaboration agreement, including Ultragenyx's collaboration agreement with Mereo, to be terminated, uncertainty and potential delays related to clinical drug development, the risk that clinical outcomes demonstrated in interim data from Ultragenyx's clinical trials may materially change or increased incidents of adverse events as patient enrollment continues and/or more patient data becomes available, Ultragenyx's ability to achieve its projected development goals in its expected timeframes, risks and uncertainties related to the regulatory approval process, smaller than anticipated market opportunities for the company's products and product candidates, manufacturing risks, competition from other therapies or products and other matters that could affect sufficiency of existing cash, cash equivalents and short-term investments to fund operations, the company's future operating results and financial performance, the timing of clinical trial activities and reporting results from same, and the availability or commercial potential of Ultragenyx's products and drug candidates. Ultragenyx undertakes no obligation to update or revise any forward-looking statements.
Contact:
Email: ir@ultragenyx.com
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