Pharmaceutical firm Alnylam progresses heart drug under joint venture with Roche to a later-stage clinical trial, overcoming mid-trial obstacle.
In a recent announcement, Alnylam Pharmaceuticals revealed the results of the Phase 2 KARDIA-3 trial for their experimental heart disease therapy, zilebesiran.
The trial, conducted in partnership with Roche, tested zilebesiran in patients with uncontrolled hypertension and high cardiovascular risk who were receiving at least two background antihypertensives. The study aimed to evaluate the therapy's impact on office systolic blood pressure reduction, with a focus on clinically meaningful effects.
The results showed that a single 300 mg dose of zilebesiran met the trial's primary goal, reducing office systolic blood pressure significantly at Month 3. However, the 600 mg dose did not lead to additional benefits at this timepoint. These benefits of the 300 mg dose were observed to last up to Month 6 in previous trials.
In terms of safety, the profile of zilebesiran remained consistent with prior studies. The on-drug arm of the latest trial saw 3.8% of participants develop serious adverse events, compared to 4.5% in the placebo arm.
Following the results of KARDIA-3, Alnylam Pharmaceuticals plans to advance the 300 mg dose of zilebesiran to a late-stage trial called ZENITH, expected to begin by the end of 2025. This global cardiovascular outcomes trial, designed to evaluate zilebesiran's potential against placebo in reducing major adverse cardiovascular events such as stroke with biannual administration, will enroll approximately 11,000 patients.
The ZENITH trial will be a partnership between Alnylam Pharmaceuticals and Roche. Alnylam expects the results to support the advancement of the 300 mg dose of zilebesiran, an RNA interference therapy, as a potential treatment for heart disease.
In addition to KARDIA-3, this is the third Phase 2 study for zilebesiran in Alnylam's KARDIA program. Alnylam Pharmaceuticals and Roche will also begin a late-stage trial for zilebesiran later this year.
