Voclosporin

Unassigned

New Medicines

Voclera · Lupus nephritis - as an adjunct to use with mycophenolate

Information

Voclera
New molecular entity
Aurinia
Aurinia

Development and Regulatory status

Phase II Clinical Trials
Phase III Clinical Trials
Pre-registration (Filed)
Mar 20 · Aurinia Pharmaceuticals initiate rolling submission of NDA to FDA [13].
Oct 19 · Aurinia Pharmaceuticals announce intention to submit rolling NDA for Lupus nephritis in the first half of 2020. With plans to launch in early 2021 [12].
Apr 17 · Company announces that following discussion with regulatory agencies, they believe that in conjunction with data from the AURA PIIb study, a single multinational PIII trial (AURORA, NCT03021499) will provide sufficient data for registration in the US, EU, and Japan [6,7].
Mar 16 · Fast-track status granted by FDA [4].

Category

Calcineurin inhibitor
In 2001, prevalence of lupus nephritis was estimated at 4.4 per 100,000 UK population [1].
Lupus nephritis - as an adjunct to use with mycophenolate
Oral

Trial or other data

Dec 19 · PIII AURORA trial (n=357) meets primary endpoint. Renal response rate was 40.8% for voclosporin with mycophenolate and low-dose corticosteroids vs. 22.5% for the control group [11].
May 18 · PIII AURORA trial is now expected to complete collection of primary outcome data in Dec 19 [9].
Apr 18 · PIII AURORA II trial (EURDRCT2016-004046-28) starts to assess the long-term safety and efficacy of voclosporin compared with placebo in patients with active lupus nephritis [10].
Jan 18 · PIII AURORA trial (NCT03021499) is recruiting; timescales unchanged [8].
Sep 16 · Aurinia follows up on topline data from its PIIb trial with publication of details of secondary endpoints. The trial of voclosporin hit all of its 24-week secondary endpoints, despite deaths in the treatment arms casting a shadow over the data. Both the low and high doses of voclosporin beat the control in time to complete remissions, respectively taking 19.7 and 23.4 weeks while the other cohort failed to generate a figure. More patients in the voclosporin arms achieved partial remission--70% and 66% compared to 49% in the control group--and took less time to reach this state. With the treatment arms also besting the control group in terms of reducing the urine protein/creatinine ratio (UPCR) and the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score, Aurinia claimed a clean sweep of secondary endpoints to go with the complete remission success it reported for the lower dose last month. The success of the lower dose of voclosporin in inducing complete remission meant the study met its primary endpoint in the topline data readout. But that success was overshadowed by deaths in the treatment arm [5].
Nov 15 · Aurinia announce that their independent Data and Safety Monitoring Board (DSMB) recommend continuation of the PIIb AURA-LV trial without any modifications [3].
Feb 15 · Aurinia initiate open-label, exploratory Aurinia early Urinary protein Reduction Predicts Response (AURION) study to assess short term predictors of response with voclosporin with mycophenolate mofetil in pts with active lupus nephritis. The trial will examine biomarkers of disease activity at 8 weeks and their ability to predict response at 24 and 48 weeks. Enrolment of patients is underway in Malaysia and is expected to be completed by Q3 of 2015. AURION study data are expected early in 2016 [2,3]
Jun 14 · Aurinia initiate a global, randomised, double-blind PIIb, 24 week trial of voclosporin in 258 pts with lupus nephritis (AURA-LV; NCT02141672). It will compare two doses of voclosporin (23.7mg and 39.5mg) administered with mycophenolate mofetil (MMF) vs. MMF alone. All patients will also receive oral corticosteroids as background therapy to induce and maintain remission. Enrolment is expected to be completed by the end of 2015 [2,3].

Mild to moderate dry eye syndrome

Information

New formulation
Aurinia
Aurinia

Development and Regulatory status

None
None
Phase III clinical trials

Category

Aqueous, preservative free nanomicellar ophthalmic solution; topical calcineurin inhibitor type immunosuppressant
Dry eye syndrome is estimated to affect between 5% and 33% of the adult population worldwide . Dry eye syndrome is more common in people aged 50 years or older, in females and in those who have had refractive surgery [3].
Mild to moderate dry eye syndrome
Topical