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Mid-stage safety profile of inclisiran spooks investors, MDCO down 6%, ALNY down 4%

Published 11/15/2016, 01:08 PM
Updated 11/15/2016, 01:08 PM
Mid-stage safety profile of inclisiran spooks investors, MDCO down 6%, ALNY down 4%
  • Alnylam (ALNY -3.9%) and collaboration partner The Medicines Company (MDCO -6.1%) hit the skids after the release of 180-day follow-up data from the Phase 2 ORION-1 study assessing inclisiran for the treatment of high cholesterol. The results were presented at the American Heart Association Annual Meeting in New Orleans, LA.
  • Investors are heading for the exits in apparent response to the safety data. On slide #8, 54% (n=198/370) of patients treated with inclisiran experienced a treatment-emergent adverse event (TEAE), including 9% (n=34/370) considered serious or severe. For comparison purposes, the TEAE rate for placebo was also 54% (n=69/127), including 8% (n=10/127) considered serious or severe.
  • There was one death (n=1/65) in the 500 mg cohort, however.
  • The numbers for liver and muscle TEAEs (slide #9) do not appear to be unreasonable. Myalgia (muscle pain) occurred in 5.7% (n=21/370) of the pooled group while liver enzyme elevations were observed in only 1.4% (n=5/370). The rates for the 300 mg cohort were 6.6% (n=8/122) and 3.3% (n=4/122), respectively.
  • The Medicines Company plans to advance inclisiran to Phase 3 development at the 300 mg dose.
  • Inclisiran (PCSK9si) is an investigational GalNAc-conjugated RNAi therapeutic targeting PCSK9, a protein regulator of LDL receptor metabolism. In contrast to PCSK9 inhibitors, PCSK9si works by turning off PCSK9 synthesis in the liver.

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