Reata Pharmaceuticals : Receives Orphan Drug Designation for Omaveloxolone for the Treatment of Malignant Melanoma
Reata is currently executing a Phase 1b/2 trial evaluating the safety and efficacy of omaveloxolone in combination with nivolumab or ipilimumab in patients with unresectable or metastatic melanoma who have failed anti-PD-(L)1 therapies. The purpose of the Phase 1b portion of the trial is to identify a recommended Phase 2 dose by collecting blood, tumor biopsy, and radiographic data to determine if omaveloxolone can unmask tumors, restore immune response, and demonstrate anti-cancer activity.
Orphan status is granted to treatments for diseases that affect fewer than 200,000 people in
Reata is a clinical-stage biopharmaceutical company that develops novel therapeutics for patients with serious or life-threatening diseases by targeting molecular pathways involved in the regulation of cellular metabolism and inflammation. Reatas two most advanced clinical candidates, bardoxolone methyl and omaveloxolone, target the important transcription factor Nrf2 that promotes the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling.
This press release includes certain disclosures that contain forward-looking statements, including, without limitation, statements regarding the success, cost and timing of our product development activities and clinical trials, our plans to research, develop and commercialize our product candidates, and our ability to obtain and retain regulatory approval of our product candidates. You can identify forward-looking statements because they contain words such as believes, will, may, aims, plans, and expects. Forward-looking statements are based on Reatas current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, (i) the timing, costs, conduct, and outcome of our clinical trials and future preclinical studies and clinical trials, including the timing of the initiation and availability of data from such trials; (ii) the timing and likelihood of regulatory filings and approvals for our product candidates; (iii) the potential market size and the size of the patient populations for our product candidates, if approved for commercial use, and the market opportunities for our product candidates; and (iv) other factors set forth in Reatas filings with the
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