Aurinia Pharmaceuticals Inc (AUPH)

[InTheTrenches]

Check out their power point presentation: (1/17):

http://c.eqcdn.com/_145f9f3f186607c6907567cb01941372/auriniapharma/db/246/890/pdf/January+Corporate+Presentation_AUPH_FINAL.pdf

Page 24:

"In previous studies, > 2000 patients have been treated with voclosporin with no abnormal or unexpected SAE’s—this remains the case upon review of the AURA data"

"13 deaths have been reported in the AURA study: pattern is consistent with other global Active LN studies1,2,3"

"11 of 13 deaths occurred at sites with compromised access to SoC; patients who died had a statistically different clinical baseline picture, demonstrating a more severe form of LN, potential comorbid conditions & poor nutrition"

"The Drug Safety Monitoring Board continues to meet on a regular basis & provides recommendations on study protocol/conduct. The AURA study remains ONGOING to its 48 week secondary endpoints"
(i.e., if DSMB thought there were any deaths directly due to the Voclosporin, safety monitoring board would have halted the trial with a clinical hold).

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SAE and Mortality comparisons of Voclosporin Phase 2b with other LN studies on Page 25

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Planned Voclosporin Phase 3 appears to have favorable endpoints compared to Phase 2b (Pages 30-31).