Dec. 10 Quick Takes: UCB’s rozanolixizumab meets in Phase III

UCB S.A. (Euronext:UCB) anticipates regulatory filings in the U.S., EU and Japan starting in 3Q22 after rozanolixizumab met its primary and all secondary endpoints in a Phase III study of adults with generalized myasthenia gravis. The subcutaneously infused mAb targeting the neonatal Fc receptor demonstrated a statistically significant change from baseline on the Myasthenia Gravis-Activities of Daily Living total score versus placebo at Day 43, the primary endpoint, without the identification of new safety signals. The magnitude of the effect and other details will be reported at a medical meeting next year. UCB is also studying zilucoplan, which it acquired from Ra Pharmaceuticals Inc. in 2019, in the disease.

Vifor Pharma Ltd. (SIX:VIFN) and Angion Biomedica Corp. (NASDAQ:ANGN) are examining a signal on a secondary endpoint after ANG-3777 missed the primary endpoint in the Phase II GUARD trial, which evaluated the therapy to treat acute kidney injury in patients undergoing cardiac surgery. The partners are looking at an endpoint measuring major acute kidney events at 90 days (MAKE90), where the hepatocyte growth factor mimic led to fewer patients having events versus placebo (14.7% vs. 21.5%, p=0.155). The primary endpoint measured increases in creatinine levels (8.4% vs. 7.3%, p=0.77). Vifor paid $60 million in upfront cash and equity for most global rights to ANG-3777 in November 2020; it has since also failed a Phase III trial in kidney transplant recipients at risk of developing delayed graft function. Angion shares were off 25% to $2.61 on Friday. Vifor slipped CHF4 to CHF118.45...