Kiniksa Announces Data from U.S. Investigator-Initiated Study of Mavrilimumab in Severe COVID-19 Pneumonia and Hyperinflammation - Seite 4

About Mavrilimumab
Mavrilimumab is an investigational fully-human monoclonal antibody that targets GM-CSFRα. Mavrilimumab was dosed in over 550 patients with rheumatoid arthritis through Phase 2b clinical studies in Europe and achieved prospectively-defined primary endpoints of efficacy and safety. Kiniksa’s lead indication for mavrilimumab is GCA, a rare inflammatory disease of medium-to-large arteries. Kiniksa is also evaluating mavrilimumab in COVID-19 pneumonia and hyperinflammation. The FDA granted Orphan Drug designation to mavrilimumab for the treatment of GCA in 2020.

About Kiniksa
Kiniksa is a biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. Kiniksa’s product candidates, rilonacept, mavrilimumab, vixarelimab and KPL-404, are based on strong biologic rationale or validated mechanisms, target underserved conditions and offer the potential for differentiation. These pipeline assets are designed to modulate immunological pathways across a spectrum of diseases. For more information, please visit www.kiniksa.com.

Forward-Looking Statements
The information contained in this press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these identifying words. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, statements regarding: our beliefs about the data from investigator initiated study showing encouraging trends of reduced mortality and duration of mechanical ventilation in patients treated with mavrilimumab as well as an early signal of efficacy; assessment as to the data from the investigator initiated study being comparable to the data from the open-label treatment protocol reported in June; our belief that the totality of the data supporting continued evaluation of mavrilimumab in severe COVID-19 pneumonia and hyperinflammation; the timing of data from the Phase2 portion of our adaptive design, placebo-controlled Phase 2/3 clinical trial of mavrilimumab in severe COVID-19 pneumonia and hyperinflammation; our belief that there will remain an unmet need for effective therapeutics to treat patients who develop severe hyperinflammation even with vaccination expected to be the mainstay of COVID-19 prevention; our Phase 2/3 clinical trial designs, including the seamless transition in enrollment of patients in both cohorts between the Phase 2 and Phase 3 portions of the trial; and the potential for all of our clinical stage product candidates to offer differentiation.