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bayoubengals88
Wisconsin Fan
LA
Member since Sep 2007
11990 posts

Aurinia Pharmaceuticals (AUPH) - Phase 3 data readout expected before year's end
And this one is not AS binary as many think:

31 October: Aurinia Announces Initiation of Patient Dosing in Phase 2/3 AUDREY™ Clinical Trial for Dry Eye Syndrome

- Voclosporin ophthalmic solution (VOS) AUDREY trial results anticipated in the second half of 2020 –

quote:

VICTORIA, British Columbia--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple inflammatory and autoimmune conditions, today announced the initiation of patient dosing in the Phase 2/3 AUDREY™ clinical trial evaluating voclosporin ophthalmic solution (“VOS”) for the potential treatment of dry eye syndrome (“DES”).

“Based upon the impressive results seen with VOS in the head-to-head exploratory Phase 2a study against cyclosporin A, we are focused on rapidly advancing this promising treatment for those who suffer from dry eye syndrome,” commented Peter Greenleaf, President and Chief Executive Officer of Aurinia. “Through the Phase 2/3 AUDREY trial, we will generate important dose-ranging and clinical data aimed at bringing VOS towards registration and commercialization.”

The AUDREY trial is a randomized, double-masked, vehicle-controlled, dose-ranging study evaluating the efficacy and safety of VOS in subjects with DES. A total of approximately 480 subjects are expected to be enrolled. The study will consist of four arms with a 1:1:1:1 randomization schedule, in which patients will receive either 0.2% VOS, 0.1% VOS, 0.05% VOS or vehicle, dosed twice daily for 12 weeks. The primary outcome measure for the trial is the proportion of subjects with a 10mm improvement in Schirmer Tear Test (“STT”) at four weeks. Secondary outcome measures will include STT at other time points, Fluorescein Corneal Staining (“FCS”) at multiple time points, change in eye dryness, burning/stinging, itching, photophobia, eye pain and foreign body sensation at multiple time points, and additional safety endpoints. Top-line results from the AUDREY clinical study are anticipated during the second half of 2020.

“Despite available therapies, DES continues to have a significant impact on individuals affected. We are encouraged by the efficacy data we saw in our exploratory study which demonstrated rapid and statistical superiority versus the current standard of care on objective signs of DES,” stated Neil Solomons, M.D., Chief Medical Officer at Aurinia. “Based on these data, the Company has gained confidence that VOS represents a potential best-in-class calcineurin inhibitor for DES.”

In January of 2019, Aurinia reported Phase 2 results demonstrating that VOS (voclosporin 0.2%) administered twice daily was superior to cyclosporin A 0.05% (Restasis®) administered twice daily across all objective endpoints including FCS and STT. This statistical superiority was observed after two weeks of dosing. The exploratory study also showed no statistically significant nor clinically meaningful difference in drop discomfort, as measured by drop discomfort scores at one and five minutes after first application, between VOS 0.2% and cyclosporin A 0.05%.

Joseph Tauber, M.D., practicing ophthalmologist and founder of the Tauber Eye Center, Kansas City, MO, commented, “To the best of my knowledge, the Phase 2 results reported by Aurinia earlier this year represent the first double-masked, randomized, head-to-head study to show objective superiority over an active comparator for DES.”

About Aurinia

Aurinia Pharmaceuticals is a late clinical-stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company is currently developing the investigational drug, voclosporin, for the treatment of lupus nephritis (“LN”), focal segmental glomerulosclerosis (“FSGS”), and DES. The Company’s head office is in Victoria, British Columbia and focuses its development efforts globally. For further information, see our website at www.auriniapharma.com.

About Voclosporin

Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor (“CNI”) with clinical data in over 2,600 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action. By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses and stabilizes the podocyte in the kidney. It has been shown to have a more predictable pharmacokinetic and pharmacodynamic relationship (potentially requires no therapeutic drug monitoring), an increase in potency (vs cyclosporin), and an improved metabolic profile compared to legacy CNIs. Aurinia anticipates that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries and until April 2028 with anticipated pediatric extension. Further, the new Notice of Allowance is expected to result in the issuance of a U.S. patent with a term extending to December 2037. If the FDA approves the use of voclosporin for LN and the label for such use follows the dosing protocol under the Notice of Allowance, the issuance of this patent will expand the scope of intellectual property protection for voclosporin to December 2037.

About Voclosporin ophthalmic solution (VOS)

Voclosporin ophthalmic solution (“VOS”) is an aqueous, preservative free nanomicellar solution intended for use in the treatment of DES. A Phase 2a study was recently completed with results released in January of 2019. Previously, a Phase 1 study with healthy volunteers and patients with DES was also completed as were studies in rabbit and dog models. VOS has IP protection until 2031.

About DES

Dry eye syndrome (“DES”) is characterized by irritation and inflammation that occurs when the eye’s tear film is compromised by reduced tear production, imbalanced tear composition, or excessive tear evaporation. The impact of DES ranges from subtle, yet constant eye irritation to significant inflammation and scarring of the eye’s surface. Discomfort and pain resulting from DES can reduce quality of life and cause difficulty reading, driving, using computers and performing daily activities. DES is a chronic disease estimated to affect more than 16 million people in the United States. There are multiple FDA approved therapies for the treatment of dry eye; however, there is opportunity for potential improvements in the effectiveness, tolerability, and onset of action.


This post was edited on 11/1 at 10:31 am


MarkInTable
LSU Fan
Dallas, TX
Member since Aug 2016
93 posts

re: Aurinia Pharmaceuticals (AUPH) - Phase 3 data readout expected before year's end
I'm holding ~300 shares until the big payday.


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tipup
LSU Fan
Member since Sep 2005
1649 posts

re: Aurinia Pharmaceuticals (AUPH) - Phase 3 data readout expected before year's end
In 2013 it was $214.00 a share? WTF happened?


MSTiger33
LSU Fan
New York City
Member since Oct 2007
15237 posts

re: Aurinia Pharmaceuticals (AUPH) - Phase 3 data readout expected before year's end
Holding big time on this one. I plan to buy more as soon as the garbage management at ADMP gets off its arse and sign Pship or BO papers.

Everything I read says AUPH is the golden goose.


bayoubengals88
Wisconsin Fan
LA
Member since Sep 2007
11990 posts

re: Aurinia Pharmaceuticals (AUPH) - Phase 3 data readout expected before year's end
quote:

In 2013 it was $214.00 a share? WTF happened?


No, it's never been about $10.50
It wasn't listed until the end of 2013


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bayoubengals88
Wisconsin Fan
LA
Member since Sep 2007
11990 posts

re: Aurinia Pharmaceuticals (AUPH) - Phase 3 data readout expected before year's end
quote:

Everything I read says AUPH is the golden goose.
My favorite thing about this company is the CEO and the management under him. These guys have so much experience, and have been successful with buyouts in the past. I mean, hell, Glickman was able to sell a drug with 10% remission rate...Voclosporin (AUPH drug) boasts a 50% remission rate. Five times better than the standard care!

I just watched Cramer's interview with Glickman from a few months ago. According to that we'll have some new indications to discuss come Friday.

But I'm with you. I'll likely keep buying below $7 (less now than when it was $3.40 though)
1,600 shares and counting.


MSTiger33
LSU Fan
New York City
Member since Oct 2007
15237 posts

re: Aurinia Pharmaceuticals (AUPH) - Phase 3 data readout expected before year's end
The management is as solid as it comes. Goal is to get at least 10,000 shares. ADMP is screwing up my timeline. I was hoping that ADMP would have popped by now. Want to roll over those gains to AUPH


bayoubengals88
Wisconsin Fan
LA
Member since Sep 2007
11990 posts

re: Aurinia Pharmaceuticals (AUPH) - Phase 3 data readout expected before year's end
I don't know this one. They're hoping for a partnership soon?


MSTiger33
LSU Fan
New York City
Member since Oct 2007
15237 posts

re: Aurinia Pharmaceuticals (AUPH) - Phase 3 data readout expected before year's end
Yeah. They have an FDA approved cheaper competitor to the EpiPen. Been sitting on it for months. They also have three generic inhalers about to enter P3. The problem is that this company has the worst management I have ever seen in a company. It is borderline criminal what they are (or should I say are not) doing.


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ynlvr
LSU Fan
Gulf Coast
Member since Feb 2009
2752 posts

re: Aurinia Pharmaceuticals (AUPH) - Phase 3 data readout expected before year's end
Bought in under $4, rode it through $10 and back, bought more at $6.98, holding big bag ‘o AUPH. Holding for a triple from here.


jmcwhrter
Member since Nov 2012
1643 posts
 Online 

re: Aurinia Pharmaceuticals (AUPH) - Phase 3 data readout expected before year's end
Been watching this one for months.. They really looking at a 2019 timeframe for Phase 3 results?


bayoubengals88
Wisconsin Fan
LA
Member since Sep 2007
11990 posts

re: Aurinia Pharmaceuticals (AUPH) - Phase 3 data readout expected before year's end
Yep. Straight from Glickman's mouth. Long wait, but that's ok.


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cuyahoga tiger
LSU Fan
NE Ohio via Tangipahoa
Member since Nov 2011
4473 posts

re: Aurinia Pharmaceuticals (AUPH) - Phase 3 data readout expected before year's end
I'm averaged at 4.87 after I sold 2/3 of my position at 8ish... buying more today... staying long... I think


bayoubengals88
Wisconsin Fan
LA
Member since Sep 2007
11990 posts

re: Aurinia Pharmaceuticals (AUPH) - Phase 3 data readout expected before year's end
So what do we have so far?

1) New indication is for Dry Eye Syndrome
Aurinia has already partnered with Merck for Canine Dry Eye, but withheld the rights to human.

2) No new capital needed.

3) Market for Lupus Nephritis up to 5.5 Billion (was 2-3 billion). The buyout price just got higher....

This post was edited on 10/20 at 7:46 am


bayoubengals88
Wisconsin Fan
LA
Member since Sep 2007
11990 posts

re: Aurinia Pharmaceuticals (AUPH) - Phase 3 data readout expected before year's end
Phase III is said to be primarily composed of healthy US and Canadian patients, which is great.


GREENHEAD22
LSU Fan
LafayettebywayofBush
Member since Nov 2009
13410 posts

re: Aurinia Pharmaceuticals (AUPH) - Phase 3 data readout expected before year's end
Is anyone seeing a drop in the future, thinking of picking some more up.


bayoubengals88
Wisconsin Fan
LA
Member since Sep 2007
11990 posts

re: Aurinia Pharmaceuticals (AUPH) - Phase 3 data readout expected before year's end
There's no reason for a drop below $6
Today's news was fantastic in every way...it just wasn't news of a buyout.


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01
MSTiger33
LSU Fan
New York City
Member since Oct 2007
15237 posts

re: Aurinia Pharmaceuticals (AUPH) - Phase 3 data readout expected before year's end
quote:

Is anyone seeing a drop in the future, thinking of picking some more up.


Its going to be a rollercoaster. I expect there will be a number of dips that will provide a number of buying opportunities.


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Ray Finkle
LSU Fan
Collier county
Member since Sep 2007
1168 posts

re: Aurinia Pharmaceuticals (AUPH) - Phase 3 data readout expected before year's end
Taking a pounding today. Yikes


chadau79
Auburn Fan
Daphne, AL
Member since Sep 2009
3198 posts

re: Aurinia Pharmaceuticals (AUPH) - Phase 3 data readout expected before year's end
Big time.


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