Ionis Pharmaceuticals' subsidiary Akcea Therapeutics has begun the Phase IIb clinical trial of AKCEA-APO(a)-L to treat patients with hyperlipoproteinemia(a) and established cardiovascular disease.
AKCEA-APO(a)-L is being developed as part of the firm's strategic collaboration with Novartis to develop drugs for patients who are at high cardiovascular risk associated with inadequately treated lipid disorders.
The product mitigates apolipoprotein(a) or Apo(a) protein production to minimise lipoprotein(a) or Lp(a), as the elevated Lp(a) leads to coronary artery disease, heart attack, stroke and peripheral arterial disease.
The dose-ranging randomised, double-blind, placebo-controlled Phase IIb trial will assess the safety and efficacy of different doses of the product in up to 270 patients.
Akcea Therapeutics chief executive officer Paula Soteropoulo said: "We believe addressing elevated Lp(a) is the next important horizon in lipid-focused therapy and, through our collaboration and option agreement with Novartis, we plan to develop AKCEA-APO(a)-L to treat patients with established cardiovascular disease in whom elevated Lp(a) plays a causal role in their disease.
"Following the achievement of specified development milestones and prior to the initiation of a Phase III study, Novartis will be able to exercise its option to license the drug.
"Upon licensing, Novartis will be responsible for worldwide development and commercialisation of AKCEA-APO(a)-L."
The product utilises Ionis' advanced ligand conjugated anti-sense (LICA) technology to enable significantly lower doses and less frequent administration when compared to non-LICA drugs.
The top-line results from the Phase IIb trial are expected to be reported in the middle of next year.
Image: Akcea initiates trial of AKCEA-APO(a)-L for lipid and heart disorders. Photo: courtesy of interphasesolution/FreeDigitalPhotos.net.