Novartis has announced that it is exercising its option to license the rights to develop and commercialise TQJ230, an investigational agent previously known as AKCEA-APO(a)-LRx, from Akcea Therapeutics.
Akcea, an affiliate of Ionis Pharmaceuticals, has developed the drug for targeted cardiovascular therapy.
The therapy, designed to reduce risk of cardiovascular disease in people living with elevated levels of inherited lipoprotein(a) (Lp(a)), was discovered by Ionis and co-developed to date by Akcea. Novartis now has responsibility for worldwide development and commercialisation.
Lp(a) is a lipoprotein that travels through the blood. Elevated levels of Lp(a) collect in the arteries, gradually narrowing the arteries and limiting blood supply to the heart, brain, kidneys and legs.
Millions of people have elevated levels, an independent inherited cardiovascular disease (CVD) risk factor, and it is estimated that 20-30% of people who suffer from CVD have elevated Lp(a).
Currently no treatment exists that specifically targets elevated Lp(a), and diet and other lifestyle changes are also not effective at reducing elevated levels.
Results of a Phase II study showed that TQJ230 significantly reduced Lp(a) in patients with high Lp(a) and pre-existing CVD.
Novartis said it plans to conduct a Phase III cardiovascular outcomes trial with the potential of addressing the Lp(a) patient community's unmet need for effective treatment.
"No treatments are currently available to substantially lower Lp(a). People with this inherited risk factor are facing cardiovascular risks that cannot be addressed effectively with lifestyle changes," said John Tsai, head of Global Drug Development and chief medical officer at Novartis.
"We're excited about the novel, RNA-targeting approach that could be a game-changer for people with elevated Lp(a). If our Phase III trial succeeds, we expect that TQJ230 will become the leading treatment option and another pillar of our longstanding commitment to re-imagining cardiovascular medicine.”