Aurinia Announces Initiation of Patient Dosing in Phase 2/3 AUDREY™ Clinical Trial for Dry Eye Syndrome
- Category: Proteins and Peptides
- Published on Friday, 01 November 2019 15:13
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- Voclosporin ophthalmic solution (VOS) AUDREY trial results anticipated in the second half of 2020 –
VICTORIA, Canada I October 31, 2019 I 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.”
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.
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.
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.
SOURCE: Aurinia Pharmaceuticals