Aurinia Pharmaceuticals (AUPH) is a clinical stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are suffering from serious diseases with a high unmet medical need, explains small cap stock expert Tom Bishop, editor of BI Research.
The company is currently developing voclosporin, an investigational drug, for the potential treatment of lupus nephritis, FSGS and Dry Eye Syndrome. Aurinia has shifted from an early stage company with one program to a late stage clinical company with multiple programs.
In its Q1 report management updated investors on its three clinical programs. The 320-patient, global 52-week Phase III “AURORA” clinical trial to evaluate voclosporin for the treatment of lupus nephritis (LN), initiated in May of 2017, is on track to complete enrollment in Q4 2018. The Company has 212 clinical trial sites activated and able to enroll patients around the globe.
More than once the company commented that it is very pleased with the progress this trial is making (“enrollment has gone extremely well”). It is optimistic of success based on data so far including the strong results from the Phase 2 trial which treated the sickest patients ever treated in an LN trial. Note there is nothing approved to treat LN, though a number of drugs are used off label.
Meanwhile in June Aurinia expects to initiate a 90-patient Phase 2a head-to-head tolerability study of voclosporin ophthalmic solution (VOS) versus Restasis for the treatment of dry eye with data due before year end. An estimated 20 million people are affected by dry eye syndrome in the U.S. alone. The goal here is to find the best in class treatment option including showing if VOS is more tolerable than Restasis.
And third, Aurinia is preparing to initiate a 20-patient phase 2 proof of concept trial to evaluate the use of voclosporin for FSGS, a rare disease that attacks the kidney’s ability to perform its filtering function. Approximately 5,400 patients are diagnosed each year with this disease.
Similar to lupus nephritis, an early clinical response reduction in proteinuria in FSGS patients is expected to be critical to long-term kidney health. Net cash used in operating activities during Q1 was $14.4 million and Aurinia has $159 million of cash, which the Company believes will be enough to accomplish the foregoing clinical trials and last into 2020.
In its closing comments during the conference call management noted, that it is “looking forward to a much busier remainder of 2018” as compared to the quieter stretch of recent months. And, “We believe the market opportunity for voclosporin to be very substantial. It is with great confidence that we continue to advance this drug in its final development phase for lupus nephritis.” The shares remain a buy.
