Replies to post #498 on Aurinia Pharmaceuticals Inc (AUPH)

[puravida]

Barry- you may have already read this but I searched yesterday for other info on the 13 deaths and this is all I could find. I agree with you that the ph2 early data looks great but the 13 deaths are concerning me. I have yet to take a position here.

"Analysts at Leerink said that the stock was trading down because there were 13 deaths across the study, with 10 in the low dose arm of the drug. The company said however that these deaths were due to the severe underlying nature of the disease, and not its drug.

“While this does naturally raise questions, it is important to be mindful that these lupus nephritis patients were extremely sick and treated at many sites with differing practice patterns in Asia, some of which we believe were in much less developed places,” Leerink said in a note to clients.

“The company noted that there were no clear underlying patterns among the deaths, and that one patient (who achieved complete remission) for example had baseline proteinurea of 29 grams, which was the highest value they have ever seen in their entire career of treating lupus patients.”



Full article below:


http://www.fiercebiotech.com/biotech/aurinia-pharmaceuticals-lupus-candidate-aces-phii-prepares-for-fda-talks

[Lunacy_John Galt]

This article touches on it. Essentially, very sick patients in Asia with very little access to reasonable healthcare...the sickest of the sick that had no business being in the trial.


http://seekingalpha.com/article/4038791-aurinia-pharmaceuticals-now-attractive-buyout-candidate?app=1&auth_param=1dm4ad:1c8cpqr:5a3eb819658673b94a22bbe15113935d&uprof=45&dr=1#alt1

[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).