Akcea Therapeutics (NASDAQ:AKCA), a majority-owned affiliate of Ionis Pharmaceuticals (NASDAQ:IONS) presents data from the Phase 2 clinical trial of vupanorsen (AKCEA-ANGPTL3-LRx) at the ESC Congress 2020.
Vupanorsen, an investigational antisense therapy being developed using Ionis’ Ligand Conjugated Antisense technology platform to reduce the production of angiopoietin-like 3 (ANGPTL3) protein from the liver which is a key regulator of triglyceride and cholesterol metabolism is used to treat patients with certain cardiovascular diseases.
In the Phase 2 study, vupanorsen met the primary endpoint of significant reductions in triglyceride (TG) levels and multiple secondary endpoints compared to placebo, with a favorable safety and tolerability profile.
A total of 105 patients with hypertriglyceridemia (fasting plasma TG levels >150 mg/dL), type 2 diabetes and non-alcoholic fatty liver disease were randomized to three dosing cohorts in a 3:1 ratio (vupanorsen:placebo) within each cohort and treated for six months.
Statistically significant dose-dependent reductions in fasting TGs at all dose levels, with the highest mean reduction of 53% at 80 mg every four weeks (44% mean reduction compared to placebo, P<0.0001).
Statistically significant dose-dependent reductions compared to placebo in ANGPTL3 (62%), very low-density lipoprotein (VLDL) cholesterol (38%), total cholesterol (19%), and non-high-density lipoprotein (non-HDL) cholesterol (18%) (mean reductions achieved with the 80 mg every four-week dose).
No effect on glycemic parameters and no decrease in hepatic steatosis and a favorable tolerability and safety profile was observed.
Also, IONS and AKCA have entered into a definitive agreement under which Ionis will acquire all of the outstanding shares of Akcea common stock, not already owned, ~24%, for $18.15/share in cash, for the total transaction value of ~$500M.
As on June 2020, AKCA had a total 101.5M common shares outstanding.
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