LifeCycle Pharma Announces Positive Topline Results from Phase II Clinical Study of LCP-Tacro Once Daily in Stable Liver Transplant Patients
-- Once daily administration
-- Improved bioavailability by approximately 30%, leading to a 70% dosing compared to Prograf(R)
-- Reduced variability (peak-to-trough ratio) with a 30% reduced peak
On Wednesday July 9, 2008, the results will be presented at the 2008 Joint International Congress of ILTS, ELITA & LICAGE in Paris.
According to LCP, the positive Phase II clinical data in stable kidney and liver transplant patients provide a very robust, statistical confirmation of the proposed dosing regimen. With the results from the clinical phase ll program, LCP expects to initiate the Phase III clinical trial program in stable transplant patients by late 2008. In addition, these data are a solid basis to conduct Phase IIb pharmacokinetic studies in de-novo kidney and liver transplant patients, subsequently leading to Phase III de-novo studies in the first half of 2009.
"We are very excited about these data", said Dr. Michael Beckert, Executive Vice President and Chief Medical Officer of LCP. "The consistency of the results across different patient populations in Phase II, both in kidney and liver transplant patients, as well as compared to our Phase I data in more than 180 healthy volunteers, is very impressive and confirms LCP-Tacro's best-in-class profile", Dr. Michael Beckert added. "This is one more milestone, we have achieved on our way towards a fully integrated speciality pharmaceutical company in the area of transplantation care and immunology".
LCP-Tacro (Liver) Phase II Clinical Study Design
The Phase II clinical study, which commenced enrollment in December 2007, was a three sequence, open-label, multi-center, prospective, conversion study in stable liver transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets Once-A-Day versus Prograf(R) (tacrolimus) capsules Twice-A-Day. Stable liver transplant patients who fulfill all I/E (inclusion/exclusion) criteria are enrolled and kept on Prograf(R) for 7 days, followed by a 14-day treatment period with LCP-Tacro tablets. Pharmacokinetic assessment was performed on Day 7 (Prograf(R)) and Day 14 & 21 (LCP-Tacro). On Day 22, patients were offered to enroll in the 52-week open-label extension study. The phase II clinical study enrolled 57 evaluable patients in 15 sites in the U.S.
About LCP-Tacro & Tacrolimus
Tacrolimus is a leading immunosuppressive medication to prevent rejection after organ transplantation. LCP-Tacro is being developed as a once-daily tablet version of tacrolimus, with improved bioavailability and reduced variability in absorption when compared to Astellas' twice daily version of tacrolimus (Prograf(R) worldwide) and its prolonged-release version of tacrolimus (Advagraf in Europe). Clinical trials have demonstrated that LCP-Tacro has a superior bioavailability and PK profile and is expected to provide significant improvements for patients currently on Prograf(R). Transplant patients need to maintain a minimum level of tacrolimus in the blood to prevent organ rejection, but too high levels increase the risk of serious side effects such as kidney damage or hypertension. Therefore, tacrolimus levels need to be managed carefully and transplant patients typically are obliged to make frequent visits to the hospital for monitoring and dose adjustments for months after receiving a new organ. Management of tacrolimus levels is complicated by the low bioavailability of Prograf(R), its variable absorption and interaction with food and other drugs. The current market size for immunosuppressants used in transplantation in the seven major markets (US, Japan, France, Germany, Italy, Spain and UK) is approximately $3.3B and growing by approximately 5-10% per year. In 2007, worldwide sales of tacrolimus were approximately $1.64 billion, with some 50% of such sales generated in the United States, and 30% in Europe.
About LifeCycle Pharma A/S ("LCP")
LCP is an emerging specialty pharmaceutical company that, through innovative technologies, is able to rapidly develop a portfolio of differentiated products to meet the unique needs of key therapeutic markets and patient populations. This includes products for immunosuppression, specifically organ transplantation, and to combat certain cardiovascular diseases. By using its unique and patented delivery technology, MeltDose(R), LCP is able to develop drugs with enhanced absorption and thereby increased bioavailability. LCP has a cholesterol lowering product, Fenoglide(TM), currently on the US market and a diversified near- and medium-term pipeline, including four product candidates in clinical trials and two in preclinical stages of development. LCP is listed on the OMX Nordic Exchange Copenhagen under the trading symbol (OMX: LCP). For further information, please visit www.lcpharma.com.
LifeCycle Pharma A/S
Hans Christian Teisen, +45 7033 3300
Executive Vice President and CFO
Posted: July 2008