BioCentury
ARTICLE | Clinical News

Roche, Chugai PNH candidate well tolerated in Phase I/II

December 21, 2018 7:21 PM UTC

Chugai Pharmaceutical Co. Ltd. (Tokyo:4519) said SKY59 (RG6107; RO7112689) was well tolerated with no treatment-related serious adverse events reported in patients with paroxysmal nocturnal hemoglobinuria (PNH) who received the humanized mAb targeting complement 5 (C5) in the Phase I/II COMPOSER trial. The company also said complete complement inhibition was achieved for all 26 evaluable PNH patients. Data were presented at the American Society of Hematology (ASH) meeting in San Diego.

The 3-part, open-label, international trial enrolled 15 healthy volunteers and 28 patients with PNH. Chugai said the first injection of SKY59 is dosed intravenously and subsequent maintenance treatment is dosed subcutaneously...