- Alnylam Pharmaceuticals Inc ALNY announced positive results from the Phase 3 APOLLO-B study of patisiran in transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy.
- The company previously announced top-line results from the APOLLO-B study in August 2022.
- The 12-month study met its primary endpoint, with patisiran demonstrating a statistically significant and clinically meaningful benefit in functional capacity as measured by the 6-minute walk test (6-MWT) compared to placebo, with a mean difference of 14, 7 meters favor of patisiran.
- The study also included additional secondary composite endpoints. A non-significant result was found for the composite endpoint of all-cause mortality, incidence of cardiovascular events, and change from baseline in 6-MW over 12 months compared to placebo.
- Patisiran also showed an encouraging safety and tolerability profile in patients with ATTR amyloidosis with cardiomyopathy.
- Patisiran produced rapid and sustained reductions in serum TTR levels with a mean percentage reduction in serum TTR reduction of 87% from baseline at month 12.
- On the safety front, patisiran showed an encouraging safety and tolerability profile, including no cardiac safety concerns compared to placebo.
- Most adverse events (AEs) were mild or moderate. The most common treatment-related AEs were infusion-related reactions and muscle cramps.
- Five deaths were observed in the patisiran-treated patients and eight in the placebo group.
- Price promotion: ALNY shares are up 2.80% to $214.72 on the latest check Thursday.
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