Alnylam Presents Positive Results From Phase 3 Study Of Patisiran In ATTR Amyloidosis

Alnylam Pharmaceuticals Inc. (ALNY) announced positive results from the APOLLO-B Phase 3 study of patisiran, an investigational RNAi therapeutic in development for the treatment of transthyretin-mediated or ATTR amyloidosis with cardiomyopathy.

According to the company, 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 or 6-MWT, compared to placebo, with a median difference of 14.7 meters favoring patisiran.

The study also met its first secondary endpoint, demonstrating a statistically significant and clinically meaningful benefit on health status and quality of life, as measured by the Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score, compared to placebo with least squares mean difference of 3.7 points 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.

As a result, formal statistical testing was not performed on the final two composite endpoints. Patisiran also demonstrated an encouraging safety and tolerability profile in patients with ATTR amyloidosis with cardiomyopathy.

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