Investor service announcement no. 8/2011
To: NASDAQ OMX Copenhagen Hørsholm, Denmark, November 10, 2011
Veloxis Pharmaceuticals Presents LCP-TacroTM Phase 3 Data at the American Society of Nephrology Annual Meeting
Veloxis Pharmaceuticals A/S (OMX: VELO) today will present detailed blinded central pathology (biopsy) results from the LCP-TacroTM study 3001 a long-term safety and efficacy switch study of LCP-TacroTM in kidney transplant recipients, at the Society of Nephrology (ASN) Kidney Week Annual Scientific Meeting. Topline results of this study were released in June 2011. The results presented today show that LCP-TacroTM once-daily was associated with a trend towards reduction in the incidence of Biopsy Proven Acute Rejection (BPAR) and a tendency for less severe histological changes compared to Prograf® twice-daily.
LCP-TacroTM Data Presented
35 needle biopsies (23 LCP-TacroTM, 12 Prograf®) were centrally read by one pathologist blinded to treatment assignment. 1 BPAR episode was recorded for 1 LCP-TacroTM patient, vs. 7 BPAR episodes in 5 Prograf® patients (5 unique Prograf® patients with 1 BPAR each; 2 patients had 2 episodes each) (p=0.21). All BPARs were mild; however, BANFF chronicity score tended to be greater in the Prograf® group (LCP-TacroTM = 2, n=1; Prograf® mean = 3.6, n=5). Overall, 1 of 162 patients randomized to receive LCP-TacroTM therapy (0.62%) and 5/162 patients randomized to receive Prograf® treatment (3.1%) in the modified intent-to-treat population had ≥ 1 centrally read BPAR (p=0.215).
Using blinded central pathology readings and including all data reported during the study prior to database lock, the composite primary efficacy endpoint (treatment failures) was met by 4 patients in the LCP-TacroTM group vs. 8 patients in the Prograf® group, p=0.38; treatment difference (95% confidence interval): -2.47% (-7.5, +1.9). The composite primary efficacy endpoint consisted of death, graft loss, BPAR and lost to follow up. The 4 LCP-TacroTM treatment failures included 3 deaths and 1 BPAR. The 8 Prograf® treatment failures included 1 death, 1 graft loss, 5 BPAR and 1 lost to follow up.
LCP-TacroTM enabled a reduction in dose of 20% through 12 months following a switch from Prograf® as measured by median tacrolimus dose (mg/kg/day) (p<0.00001). Mean tacrolimus trough levels throughout the study were comparable and within the 4-15 ng/mL protocol-specified target range for both groups. Tacrolimus trough levels preceding each BPAR were within the protocol-specified 4-15 ng/mL target range. Mean GFR tended to be higher for the LCP-TacroTM group.
These results are consistent with previous clinical studies and PK results that demonstrated higher bioavailability (LCP-TacroTM patients, on average, required a daily dose that was 20% lower than patients receiving Prograf®, reflecting the improved absorption provided by the MeltDose® formulation) and comparable efficacy versus Prograf® on predefined endpoints.
“The results we have seen in this Phase III study suggest that LCP-TacroTM is non-inferior to Prograf® in the predefined primary endpoints when LCP-TacroTM is dosed at once a day,” said Dr. Suphamai Bunnapradist, M.D., Professor of Medicine and Director of Kidney Transplant Research at the Ronald Reagan Medical Center and David Geffen School of Medicine at UCLA, California, USA., “These data concerning rejection rates, although small and not sufficiently powered to be clinically meaningful, are promising and offer new avenues for additional research and possible submissions to FDA.”
For more information, please contact:
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John Weinberg, M.D. SVP, Commercial Operations & Investor Relations Tlf: +1 908 304 3389 Email: jdw@veloxis.com |
Johnny Stilou Chief Financial Officer Tlf: +45 2055 3852 Email: jst@veloxis.com |
Veloxis Pharmaceuticals A/S (VELO)
Based in Hørsholm, Denmark, with an office in New Jersey, Veloxis Pharmaceuticals A/S, or Veloxis, is a specialty pharmaceutical company. Clinical development is the core of Veloxis’ efforts to develop a product portfolio which includes the Company’s lead product candidate, LCP‐TacroTM for immunosuppression, specifically organ transplantation, and products to combat certain cardiovascular diseases. Veloxis adapts new technologies on a fast commercial timetable. Veloxis’ unique, patented delivery technology, MeltDose®, can improve absorption and bioavailability ‐ at low‐scale up costs ‐ not only for a broad spectrum of drugs already on the market but also for new chemical entities. Veloxis has a lipid lowering product, Fenoglide®, currently on the U.S. market and a diversified near and medium term pipeline with three clinical stage product candidates and a number of projects in preclinical development. Veloxis is listed on the NASDAQ OMX Copenhagen under the trading symbol OMX: VELO.
For further information, please visit www.veloxis.com.
