Aurinia Pharmaceuticals Inc (NASDAQ:AUPH) announced positive results from its 48-week Phase 2B study. The results not only achieved the complete and partial remission objectives, they were even superior over the 24-week results. Phase 3 study commence soon and has a high probability of success.
The buzz
Aurinia is a Canadian, clinical-stage, biotech firm based in Victoria, focused on the advancement of its lead medication voclosporin for the treatment of Lupus Nephritis. It quotes the Lupus Foundation of America’s prediction that almost 500,000 to over 1.5 million people in the U.S., and up to 5 million people globally, suffer from “SLE”. Almost 40% to 60% of people with SLE develop LN.
Lupus Nephritis is an inflammation of the kidney resulting out of SLE which, if left inadequately treated or untreated, can result in end-stage renal disease, renal transplant, death and dialysis, making it a serious and life-threatening condition. As of now, there are no LN therapies are approved by FDA or EMA.
Aurinia appears to be an attractive takeover target. Analysts expected that the 48-week report from its AURA Phase IIB voclosporin trial success would be successful. Also, they anticipated that those 48-week study report would be issued sometime between February and March 2017. The FDA has allowed company’s plan of a single arm Phase 3 study using the low dose which is anticipated to start in 2Q2017.
Aurinia issued top-line, 48-week data from its Phase 2b AURA-LV study in lupus nephritis which was impressive. It resulted in heavy pre-opening and after-hours trading.
Assuming the Phase 3 trial commences in April 2017, the company has released projection that it intends to take up to 18 months to enroll the 320 people for the trial. But, in light of the modification in recruiting requirement to permit LN patients to use biopsy report up to 24 months old compared to six-month old report for subjects in the AURA Phase IIB study, and considering much higher profile that company has received following recent report, recruitment may just take 12 months.
