
- Alnylam Pharmaceuticals Inc ALNY announced results from exploratory endpoints and additional analysis from the phase 3 APOLLO-B study of patisiran in transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy.
- The RNAi drug maintained “generally consistent” efficacy and quality of life benefits across multiple pre-specified subgroups at month 12, Alnylam announced.
- It also revealed more details on a key flaw, a composite secondary endpoint, including all-cause mortality. The researchers found that the numbers trended towards a benefit for patisiran, with 10 deaths from all causes in the placebo group versus four in the treatment group.
- Related: Alnylam shares detailed patisiran data from a rare disease study.
- Alnylam also presented a handful of echocardiographic parameters, or analyzes of heart images generated by sound waves.
- Patisiran demonstrated statistically significant benefits over placebo, including longitudinal strain (p=0.0324) and LV mass (p=0.0402). The p-value for LV end-diastolic volume was slightly above 0.05, and no significant differences were found in mean or relative LV wall thickness and cardiac output.
- The company plans to submit a supplemental regulatory submission for ATTR amyloidosis with cardiomyopathy based on the APOLLO-B data by the end of the year.
- Price promotion: ALNY shares closed down 4.41% at $200.16 on Friday.
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