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Aurinia Pharmaceuticals Inc (AUPH)

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Last Post: 8/21/2017 4:31:58 PM - Followers: 147 - Board type: Free - Posts Today: 8

Aurinia is a late-stage biopharmaceutical company providing novel products specifically engineered to treat a limited, targeted patient population suffering from serious disease states for which there is a high unmet medical need.

*Aurinia Pharmaceuticals Inc.
http://www.auriniapharma.com/
 

Pipeline

 

Pipeline

Pipeline

Candidate & Indication Development Stage
Preclinical Phase 1 Phase 2 Phase 3 Market
VOCLOSPORINLupus Nephritis (LN)
Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase in progress
Phase 3 Phase not started
Market Phase not started

Aurinia is committed to working in areas of high unmet medical need and is poised to deliver the first approved therapy in the U.S. and Europe for the treatment of lupus nephritis, or LN.

The Voclosporin Advantage

Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor (“CNI”) with clinical data in over 2,000 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action that has the potential to improve near- and long-term outcomes in lupus nephritis (LN) when added to standard of care mycophenolate mofetil (MMF). It has been granted “fast track status” by the U.S. Food & Drug Administration (FDA).

Voclosporin Could Transform the LN treatment Landscape

Voclosporin has the potential to become a best in class medication and the first approved treatment for LN in the U.S. and Europe, effectively altering the current treatment paradigm for the disease.

Advantages of Voclosporin Combined with Standard of Care (SoC)

Our clinical data suggests that adding voclosporin to the current SoC of MMF for the treatment of lupus nephritis (LN) will yield superior results to using the standard of care alone.

Additionally, voclosporin may prove to be an ideal therapy for lupus nephritis due to advantages such as:

  • Improved efficacy
    Increased safety
    Oral administration
    Improved average time to renal response or remission
    Improved duration of renal response
    Reduction in steroid burden
    Potential first line add-on to MMF
    Fewer toxic immunosuppressants required
Benefits of Voclosporin

Potential Benefits of Voclosporin

In clinical trials, Voclosporin has been shown to be especially effective in the presence of low dose steroids with rapid reduction of LN inflammatory markers and overall improved renal stability.

The list of potential product benefits includes:

LN Critical Need Voclosporin (based on AURA Results)
Control of Active Disease
Rapid Disease Control
Lower Steroid Burden
Impact on Extra-renal disease
Convenient Treatment Regimen

In previous studies, over 2000 patients have been treated with Voclosporin with no abnormal or unexpected SAE’s

Well Characterized Safety Profile

Efficacy of calcineurin inhibition has already been established. Voclosporin has a well-characterized safety profile (over 2,000 patient exposures across multiple years) across indications.

No new safety signals were observed with the use of Voclosporin in LN patients; Voclosporin was well-tolerated and renal function remained stable in clinical studies. The overall safety profile is consistent with other immunosuppressive drugs.

 

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PostSubject
#4884  Sticky Note AUPH: Now that Ph3 for LN is underway Lunacy aka John Galt 07/19/17 06:05:27 PM
#5280   Thanks John Galt! Hotrodder1 08/21/17 04:31:58 PM
#5279   Thanks Luna. With not a competition in sight, Jesspro 08/21/17 04:12:13 PM
#5278   Jess, here is some info on P-values and Lunacy aka John Galt 08/21/17 12:19:51 PM
#5276   it because of the eclipse cervelo 08/21/17 11:24:05 AM
#5275   On second thought, looks like $5's have arrived.... biotech_researcher 08/21/17 10:23:18 AM
#5274   I expect we have bottomed here..... biotech_researcher 08/21/17 08:58:57 AM
#5273   I don't sell. I add more when it grandma_of_jbraika 08/21/17 06:13:19 AM
#5272   I sure don't see that..... biotech_researcher 08/20/17 08:36:03 PM
#5268   The dog and pony pessimism show makes me SvsB 08/20/17 02:43:02 PM
#5267   Luna, how is P-value determined and how was Jesspro 08/20/17 06:47:10 AM
#5266   Stellar management team, great science, Aspreva success, stellar grandma_of_jbraika 08/20/17 12:29:31 AM
#5265  Restored "No wonder AUPH management is in no hurry biotech_researcher 08/19/17 08:35:46 PM
#5264   The FDA likes double blind with no peeking The Lost Trader 08/19/17 08:33:19 PM
#5263   No wonder AUPH management is in no hurry Jesspro 08/19/17 08:28:40 PM
#5262   Jess, they said this: Pts with LN: What is biotech_researcher 08/19/17 08:10:18 PM
#5261   Jess, The Kidney Foundation completely disagrees with your point.. biotech_researcher 08/19/17 08:07:23 PM
#5260   "Hard to find a better risk/reward play grandma_of_jbraika 08/19/17 07:32:19 PM
#5259   Exactly that The Lost Trader 08/19/17 07:02:03 PM
#5258   Lost, This is a 100% unmet medical need Jesspro 08/19/17 07:01:26 PM
#5257   How is lupus treated? biotech_researcher 08/19/17 04:21:21 PM
#5256   Nothing...SLE is being attempted but Voc is a The Lost Trader 08/19/17 04:00:20 PM
#5255   Lost, are there any strong competition on par Jesspro 08/19/17 03:59:01 PM
#5254   Hope everyone here is doing well! Been The Lost Trader 08/19/17 12:01:44 AM
#5253   Oh brother............ biotech_researcher 08/18/17 07:35:45 PM
#5252   no one claimed they held AUPH. I was zzaatt 08/18/17 03:21:46 PM
#5251   Warren Buffett biotech_researcher 08/18/17 02:40:40 PM
#5250   I also forgot Robert Duggan.....oh wait. SvsB 08/18/17 12:58:21 PM
#5249   So you're surprised but not curious? I'm moosedogger 08/18/17 12:42:44 PM
#5248   You left out Ray Dalio moosedogger 08/18/17 12:39:40 PM
#5247   So it wasn't just Warren Buffett but also SvsB 08/18/17 12:36:13 PM
#5246   Give us a legitimate negative on Auph, I'm Lunacy aka John Galt 08/18/17 12:28:14 PM
#5245   SvsB, better re-read that post again. No reference biotech_researcher 08/18/17 12:27:57 PM
#5244   On the stocks that I own, I take biotech_researcher 08/18/17 12:25:59 PM
#5243   OK, I'll bite. Do us a favor moosedogger 08/18/17 12:12:50 PM
#5242   Is he like Warren Buffett or something? if SvsB 08/18/17 12:05:12 PM
#5241   Over on the Biotech Values board, Dew and biotech_researcher 08/18/17 11:24:47 AM
#5240   Peter Lynch: "If you like a stock at grandma_of_jbraika 08/18/17 10:43:01 AM
#5239   If Glickman's wish should happen (going-it-alone), this baby Jesspro 08/18/17 10:32:28 AM
#5238   We have no idea when the BO will Lunacy aka John Galt 08/18/17 09:49:02 AM
#5237   Yeah, I have no idea what people were Awlau 08/18/17 09:38:42 AM
#5236   Moose, As I said before, the more they Jesspro 08/17/17 10:08:34 PM
#5235   I can't add anything new.....I'm just referencing what moosedogger 08/17/17 05:03:24 PM
#5234   That 30% was incorrect by MF. Take Lunacy aka John Galt 08/17/17 04:52:59 PM
#5233   "due to AUPH's really strong position/advantages. " Moose, can biotech_researcher 08/17/17 04:41:23 PM
#5232   The claimed 30% chance of P3 success is moosedogger 08/17/17 04:19:26 PM
#5231   "....there are no degrees to integrity, (high/low), you moosedogger 08/17/17 12:04:03 PM
#5230   1.2 billion in sales x 4 x 30% greggors 08/17/17 11:54:19 AM
#5229   I love how they always talk so positive cervelo 08/17/17 11:51:21 AM
#5228   Three and a half reasons to buy Aurinia Jesspro 08/17/17 10:40:53 AM
#5227   Very well said!!! EOM wilco244 08/17/17 07:50:49 AM
PostSubject