Akcea Therapeutics (NASDAQ:AKCA) should first plan for a Phase III study for AKCEA-APO(a)-LRx to determine the exact levels of lipoprotein Lp(a) reduction and cardiovascular (CV) risk before proceeding to a cardiovascular outcome trial (CVOT), experts said.
Akcea, a wholly owned subsidiary of Ionis Pharmaceuticals (NASDAQ:IONS), announced in February the ongoing Phase IIb study in patients with high lipoprotein(a) (Lp(a)) and established cardiovascular disease (CVD) will determine the dose level and frequency of administration for a future Phase III CVOT. However, experts said these elements should first be sorted in a Phase III, prior to a CVOT. Analysts have said an antisense technology such as ACKCEA-APO(a)-LRx can stop the production of all forms of Apo(a) and therefore form the basis for a large CVOT trial.
Despite the need to determine Lp(a) production to move forward, it will be difficult to do so because of uncertainty on the best means to measure the protein, experts said. The reduction in Lp(a) is important as high levels have been associated with an increase in atherosclerosis, they added.