Phase III studies in stable kidney transplant patients complete Phase III studies in de novo kidney transplant patients ongoing
Worldwide - Veloxis Pharmaceuticals
Phase II clinical studies complete - De novo and stable liver transplant patients
Worldwide - Veloxis Pharmaceuticals
LCP-Tacro™ is being developed as a once-daily dosage version of tacrolimus for the treatment of kidney and liver transplant patients. Compared with Astellas Pharma's Prograf®, a twice-daily dosage version of tacrolimus, and Advagraf®, a once-daily dosage version of tacrolimus for organ transplants which was approved by the EMA in mid-2007, Veloxis believes that LCP-Tacro™ would have the following potential key differences:
Improved systemic absorption and reduced variability
Improved bioavailability, and thus requiring a lower dose of tacrolimus
Limited peak-to-trough fluctuation
Veloxis believes that physicians may find LCP-Tacro™'s once-daily dosing and non-substitutability by generics attractive.
Development Strategy and Status
Veloxis announced in June 2011 the top-line results of a clinical phase 3 study in stable kidney transplant patients. In this non-inferiority study, LCP-Tacro™ dosed once a day successfully met all primary efficacy and safety end points when compared with the current leading transplant drug, Prograf®, dosed twice a day. LCP-Tacro™ demonstrated a trend toward lower rejection rates as determined by a central blinded pathology reading, and similar safety and tolerability profiles were demonstrated across both groups in the study. The results were achieved with significantly lower doses of LCP-Tacro™ compared with Prograf®.
Top-line results from a clinical phase 3 study in patients who just received a kidney transplant (de novo) are expected by early 2013, after which Veloxis expects to submit applications for registration in the EU and US in the first half of 2013.
Veloxis has completed phase 2 clinical studies in stable and maintenance kidney and liver transplant patients. In addition, Veloxis conducted 9 phase 1 clinical studies with LCP-Tacro™, including a head-to-head clinical study in healthy volunteers. Clinical data confirmed that LCP-Tacro™, when compared with Advagraf® the Astellas Pharma once-daily version of tacrolimus, marketed only in Europe), demonstrated approximately 30% higher bioavailability. LCP-Tacro™ also showed a flatter pharmacokinetic profile and/or decreased variability and a potential for administration at lower daily doses when compared with Advagraf®.
On 10 August 2007, the FDA approved FenoChol™ for the treatment of dyslipidemia in the US. Veloxis outlicensed the marketing of FenoChol™ for the US, Canada, and Mexico to Shionogi Pharma (formerly Sciele Pharma, Inc), which launched the product under the brand name Fenoglide® in the US in February 2008. The royalty stream from Fenoglide® was sold to Cowen Healthcare Royalty Partners in 2008. Rights for Fenoglide® for these territories were transferred to Shore Therapeutics, Inc, in 2010.
AtorFen™, which has completed phase 2 clinical studies for the treatment of dyslipidemia, is a combination therapy based on a fixed-dose combination of atorvastatin (the active ingredient in Lipitor®) and a low dose of fenofibrate without food effect. Thus, the product candidate is designed to combine in a small tablet a proven statin and a fenofibrate in a treatment that addresses all 3 atherosclerosis risk parameters: elevated low-density lipoprotein cholesterol, elevated triglycerides, and high-density lipoprotein cholesterol. Veloxis continues to pursue potential partnership opportunities for AtorFen™, which could include phase 3 studies.
LCP-Feno™ is designed to be an AB-rated, substitutable version of Tricor® 145 mg for the treatment of dyslipidemia. LCP-Feno™ is currently available for partnering.