AstraZeneca, Ionis antisense drug helps reduce cholesterol levels in mid-stage study
AstraZeneca (NASDAQ:AZN) and Ionis Pharmaceuticals (NASDAQ:IONS) said a phase 2b study of antisense medicine ION449 (AZD8233) for reducing blood cholesterol levels in patients with hypercholesterolemia met its main goal.
The companies said the phase 2b study, dubbed ETESIAN, of self-administered ION449 met its main goal in reducing serum LDL-C (also called bad cholesterol) levels by up to 79%.
Both the 50mg and 90mg doses reached statistically significant and clinically meaningful reductions in LDL-C levels from baseline of 73% and 79%, respectively, versus 2% for placebo.
The companies said reductions in LDL-C were maintained until week 14 (6 weeks after the last dose).
The trial also met the secondary goals, including significantly reducing proprotein convertase subtilisin/kexin type 9 (PCSK9) levels by up to 94%.
The companies noted that reducing PCSK9 levels leads to lower LDL-C levels in the bloodstream, which is known to reduce the risk of developing coronary heart disease.
The drug was was generally well tolerated, according to the April 4 press release.
"The results underscore ION449's (AZD8233) potential best-in-class efficacy profile and support further development of ION449 (AZD8233) as a next-generation PCSK9 inhibitor that is self-administered monthly," said Mene Pangalos, executive vice president and president, BioPharmaceuticals R&D at AstraZeneca.