Alnylam Pharmaceuticals Inc (NASDAQ: ALNY) announced positive results from the APOLLO-B Phase 3 study of patisiran for transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy.
The company previously announced topline results from the APOLLO-B study in August 2022.
The 12-month study achieved its primary endpoint, with patisiran demonstrating a statistically significant and clinically meaningful benefit on functional capacity, as measured by the 6-Minute Walk Test (6-MWT), compared to placebo, with a median difference of 14.7 meters favoring patisiran.
The study also included additional secondary composite outcomes endpoints. A non-significant result was found on the composite endpoint of all-cause mortality, frequency of cardiovascular events, and change from baseline in 6-MWT over 12 months compared to placebo.
Patisiran also demonstrated an encouraging safety and tolerability profile in patients with ATTR amyloidosis with cardiomyopathy.
Patisiran achieved a rapid and sustained reduction in serum TTR levels, with a mean percent reduction from baseline in serum TTR reduction of 87% at Month 12.
On the safety front, Patisiran demonstrated an encouraging safety and tolerability profile, including no cardiac safety concerns relative to the placebo.
Most adverse events (AEs) were mild or moderate in severity. The most common treatment-emergent AEs were infusion-related reactions and muscle spasms.
Five deaths were observed in patisiran-treated patients and eight in the placebo group.
Price Action: ALNY shares are up 2.80% at $214.72 on the last check Thursday.
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