Press Releases
Akcea Initiates Phase 2b Study of AKCEA-APOCIII-LRx in Patients with Hypertriglyceridemia and Established Cardiovascular Disease
AKCEA-APOCIII-LRx is part of a strategic collaboration with
AKCEA-APOCIII-LRx, an antisense drug that uses Ionis’ advanced LIgand Conjugated Antisense (LICA) technology, is designed to reduce the production of apolipoprotein C-III, or apoC-III. Elevated levels of apoC-III correlate with high triglyceride levels and have been associated with metabolic abnormalities and premature cardiovascular disease.
“The combination of elevated levels of apoC-III and triglycerides has long been linked with cardiovascular disease, but, until now, no drug has been capable of addressing both risk factors. In our Phase 1 study AKCEA-APOCIII-LRx significantly reduced both apoC-III and triglycerides up to 84% and 71%, respectively, and demonstrated a good safety and tolerability profile,” said Louis O’Dea, chief medical officer at Akcea Therapeutics. “These data strongly support further evaluation of AKCEA-APOCIII-LRx. We believe positive results from studies in this broad patient population could lead to wide-ranging advances in the treatment of people with apoC-III and triglyceride-driven cardiovascular disease.”
The multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase 2b study will evaluate the safety and efficacy of AKCEA-APOCIII-LRx in approximately 100 patients with hypertriglyceridemia and established CVD. Akcea anticipates reporting top-line data from this study in 2019. For further study information, please visit www.clinicaltrials.gov and search for AKCEA-APOCIII-LRx.
Akcea recently reported data from a Phase 1/2a clinical study of AKCEA-APOCIII-LRx in healthy volunteers and patients with elevated triglyceride levels. Patients in the study were treated with multiple doses at either weekly or monthly dosing intervals. Patients treated with AKCEA-APOCIII-LRx demonstrated significant dose-dependent reductions in apoC-III protein and triglycerides. No serious adverse events, no platelet count reductions or changes in liver function, and no adverse events leading to treatment discontinuation were observed.
ABOUT THE AKCEA AND NOVARTIS COLLABORATION
In January 2017, Akcea and Ionis entered into an exclusive, worldwide option and collaboration agreement with
ABOUT AKCEA-APOCIII-LRx
AKCEA-APOCIII-LRx is a ligand conjugated antisense (LICA) drug designed to reduce the production of apolipoprotein C-III, or apoC-III. ApoC-III is a protein produced in the liver that plays a central role in the regulation of serum triglycerides. Genetically reduced levels of apoC-III are correlated to lower levels of triglycerides and lower risk of cardiovascular disease whereas elevated levels of apoC-III correlate with high triglyceride levels that have been associated with multiple metabolic abnormalities, such as insulin resistance and/or metabolic syndrome. Akcea and Ionis are developing AKCEA-APOCIII-LRx to treat hypertriglyceridemia and established cardiovascular disease.
In a Phase 1/2a clinical study in healthy volunteers and patients with elevated triglyceride levels, treatment with multiple doses of AKCEA-APOCIII-LRx resulted in dose-dependent reductions in apoC-III protein of up to 84% after six weeks of treatment. Treatment with AKCEA-APOCIII-LRx also resulted in dose-dependent reductions in triglycerides of up to 71%. Significant dose-dependent reductions of up to 30% in apolipoprotein B (apoB) and increases of up to 100% in high-density lipoprotein cholesterol (HDL-C), were also observed. Both decreased levels of apoB and increased levels of HDL-C are associated with decreased cardiovascular risk. AKCEA-APOCIII-LRx was well tolerated in the study. No serious adverse events, no platelet count reductions or changes in liver function, and no adverse events leading to treatment discontinuation were observed. Phase 1 studies of all three of Akcea’s LICA drugs have shown that doses up to 30 fold lower than non-LICA drugs result in consistent target reductions and a favorable safety and tolerability profile.
ABOUT
FORWARD-LOOKING STATEMENT
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In this press release, unless the context requires otherwise, “Ionis”, “Akcea,” “Company,” “Companies” “we,” “our,” and “us” refers to
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Media and Investor Contact:
Kathleen Gallagher
Head of Communications and Investor Relations, Akcea Therapeutics
(617)-207-8509
kgallagher@akceatx.com
Source: Akcea Therapeutics, Inc.