BioCentury
ARTICLE | Product Development

Feb. 6 Quick Takes: Idorsia falls on Phase III miss 

Plus: Arrowhead awaits J&J’s decision on HBV partnership and updates from Dragonfly, Sage-Biogen, IgGenix, Certa and more  

February 7, 2023 12:44 AM UTC
Updated on Feb 7, 2023 at 7:36 PM UTC

More than a decade after its first Phase III readouts in aneurysmatic subarachnoid hemorrhage (aSAH), a higher dose of clazosentan from Idorsia Ltd. (SIX:IDA) missed the primary endpoint in the Phase III REACT study, sending shares down CHF2.20 (14%) to CHF13.73 on Monday. In the 409-patient study, a 15 mg/hour dose of clazosentan following an aSAH failed to prevent clinical deterioration due to delayed cerebral ischemia vs. placebo. The REACT study was designed after the CONSCIOUS-2 study showed a 5 mg/hour dose of clazosentan failed to generate a statistically significant treatment effect in 2010, but an exploratory analysis in the terminated CONSCIOUS-3 study suggested a 15 mg/hour dose reduced mortality and ischemic neurologic deficit.

Although a report suggested Johnson & Johnson (NYSE:JNJ) is winding down a pipeline program for HBV, the pharma’s partner Arrowhead Pharmaceuticals Inc. (NASDAQ:ARWR) has yet to receive a termination notice for the companies’ 2018 deal around JNJ-3989 (ARO-HBV). In a story published Friday, FierceBiotech said J&J would combine its vaccines and infectious disease units and cull some programs, including in hepatitis. In a statement to BioCentury, Arrowhead acknowledged that J&J is deprioritizing HBV and added, “It is our understanding that some legacy HBV studies are continuing but we do not know where JNJ-3989 will ultimately end up. We will assess our options and rights when Janssen decides the path forward for the program.” Arrowhead slipped $3.23 to $33.51 on Monday...