Aurinia Announces Outcome of AUDREY™ Clinical Trial in Dry Eye Syndrome
November 02 2020 - 4:05PM
Business Wire
- The trial did not achieve statistical
significance on the primary endpoint of ≥ 10mm improvement in
Schirmer Tear Test (STT) at 4 weeks – - Company to suspend
development program for voclosporin ophthalmic solution (VOS) - -
Aurinia to host conference call today at 4:30 p.m. EST -
Aurinia Pharmaceuticals Inc. (Nasdaq: AUPH / TSX:AUP) (“Aurinia”
or the “Company”), a late-stage clinical biopharmaceutical company,
today announced topline data from the Phase 2/3 AUDREY™ clinical
study evaluating voclosporin ophthalmic solution (VOS) for the
potential treatment of dry eye syndrome (DES). The trial did not
achieve statistical significance on its primary endpoint of a 10mm
or greater improvement in STT at four weeks between active dose
groups of VOS compared to vehicle. Aurinia is suspending the
development program for VOS based upon these results.
“First and foremost, we would like to thank the patients and
investigators who participated in the AUDREY clinical trial. Based
upon these initial topline results that we continue to interrogate,
we are suspending the DES program at this time,” commented Peter
Greenleaf, President and Chief Executive Officer of Aurinia. “While
surprised by these results, we remain focused on preparing
voclosporin for lupus nephritis – which has a different formulation
and delivery mechanism compared to VOS. As we approach our lupus
nephritis PDUFA action date, the Aurinia team remains committed to
our mission of developing novel treatments for people with
debilitating and severe autoimmune disease.”
The AUDREY trial was a randomized, double-masked,
vehicle-controlled, dose-ranging study evaluating the efficacy and
safety of VOS in subjects with DES. A total of 508 subjects were
enrolled. The study consisted of four arms with a 1:1:1:1
randomization schedule, in which patients received 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 was the proportion of
subjects with a 10mm or greater improvement in STT at four
weeks.
Measure
Result (%)
Odds-Ratio (vs.
vehicle) [95% CI]
p-value (vs.
vehicle)
Primary Endpoint
Percentage of patients with a ≥
10mm improvement from baseline in a Schirmer Tear Test at 4
weeks
VOS 0.05% =10%
2.18 [0.62, 7.62]
p = 0.09
VOS 0.1% = 9%
1.78 [0.49, 6.45]
p = 0.28
VOS 0.2% = 11%
2.48 [0.70, 8.30]
p = 0.13
Vehicle = 5%
N/A
N/A
“While we are understandably disappointed that VOS did not
achieve the primary endpoint of the AUDREY trial, we uncovered
important learnings about this disease state, particularly
concerning the patient population with severe dry eye syndrome,”
commented Neil Solomons, M.D., Chief Medical Officer.
Secondary outcome measures evaluated in the trial included 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. Initial
analysis of these secondary outcomes suggests dose-dependent
activity and safety were observed across dose groups compared to
vehicle. Further analysis of the AUDREY dataset will be conducted
over the coming weeks.
Conference Call Information
Aurinia will host a conference call and webcast to discuss these
results today, Monday, November 2, 2020 at 4:30 p.m. EST. The
webcast can be accessed on the investor section of the Aurinia
website at www.auriniapharma.com. To participate in the
teleconference, please dial +1-877-407-9170 (Toll-free U.S. &
Canada).
About Aurinia
Aurinia Pharmaceuticals is a late-stage clinical
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 seeking FDA approval of voclosporin for the potential
treatment of LN. The Company’s head office is in Victoria, British
Columbia and its U.S. commercial hub is in Rockville, Maryland. The
Company focuses its development efforts globally.
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version on businesswire.com: https://www.businesswire.com/news/home/20201102005888/en/
Investors & Corporate: Glenn Schulman, PharmD, MPH
Corporate Communications, Aurinia gschulman@auriniapharma.com
Media: Stefan Riley Ten Bridge Communications
stefan@tenbridgecommunications.com
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