LUVENIQ (LX211) is the oral form of a next-generation calcineurin inhibitor, voclosporin. Like other molecules of this class, the compound reversibly inhibits immunocompetent lymphocytes, particularly T-lymphocytes, and it also inhibits lymphokine production and release.

LUVENIQ (oral voclosporin) was discovered by the team of scientists currently at Isotechnika Pharma, Inc. in Edmonton, Alberta, Canada based on unique insights into the in vivo metabolism of calcineurin inhibitors. LUVENIQ is highly potent in various animal models of autoimmune diseases, including experimental uveitis. LUVENIQ is differentiated from the first-generation calcineurin inhibitors by its molecular structure and binding to its biologic target calcineurin phosphatase, and by its metabolic pathway and the associated pharmacokinetic and pharmacodynamic features, which may be linked to advantages in safety.

Lux Biosciences recently announced the results of its Phase 2/3 clinical development program of LUVENIQ in non-infectious uveitis. LUVENIQ at the 0.4 mg/kg BID dose was superior to placebo in reducing active posterior segment inflammation in the LX211-01 study at both Week 16 (p<0.01) and Week 24 (p<0.05), the co-primary efficacy endpoints of the study. In the LX211-02 study, LUVENIQ at the 0.4 mg/kg BID dose demonstrated a 50% greater reduction than placebo (p<0.05) in the primary endpoint of the study, inflammatory exacerbation rate at 6 months in subjects with medically controlled posterior segment disease. Increased blood pressure, decreased renal function and hirsutism were the drug related adverse events observed at a rate of approximately 5% increment over placebo, overall giving rise to a safety profile that appears conducive for chronic use. A New Drug Application (NDA) and a Marketing Authorization Application (MAA) are currently being prepared for submission to the US Food and Drug Administration (FDA) and to the European Medicines Agency (EMEA), respectively.  Lux Biosciences has exclusive worldwide rights to voclosporin for ophthalmic use and is cooperating with the team at Isotechnika Pharma who develop it in other indications. If regulatory approval is granted, LUVENIQ would be the first immunomodulatory therapy for the treatment of uveitis available in the United States.