Theravance Announces Positive Topline Results In Phase 3 Telavancin Hospital-Acquired Pneumonia Program
Wednesday December 5, 4:05 pm ET
SOUTH SAN FRANCISCO, CA--(MARKET WIRE)--Dec 5, 2007 -- Theravance, Inc. (NasdaqGM:THRX - News) today announced positive results from the ATTAIN 1 and ATTAIN 2 studies assessing the safety and efficacy of telavancin, a rapidly bactericidal, once-daily injectable investigational antibiotic for the treatment of hospital-acquired pneumonia (HAP), including patients with ventilator-associated pneumonia (VAP), caused by Gram-positive bacteria such as methicillin-resistant Staphylococcus aureus (MRSA).
In each study, telavancin achieved its objective of non-inferiority in the all-treated (AT) and clinically evaluable (CE) patient populations. In the CE population from ATTAIN 1 and ATTAIN 2 combined, the clinical cure rate for telavancin was 82.7%, compared with 80.9% for vancomycin.
"We are in the midst of a worrisome increase in the occurrence of MRSA pneumonia," said Ethan Rubinstein, M.D., the co-principal investigator in the ATTAIN studies and Head of Infectious Diseases and Professor of Medicine at the University of Manitoba. "In addition, there is a growing incidence of MRSA with reduced susceptibility to vancomycin, leaving too few treatment options."
"In the microbiologically evaluable patients who were infected with MRSA alone, I was pleased to see that treatment with telavancin resulted in numerically higher cure rates of 82%, compared with 74% for vancomycin. The difference did not reach statistical significance but is clinically meaningful," said Ralph Corey, M.D., Professor of Medicine at the Duke University Medical Center and the principal investigator in the ATTAIN studies. "Additionally, encouraging trends in clinical outcomes were seen in patients treated with telavancin compared with those treated with vancomycin in many of the most severely ill patient populations, including those with bacteremia, high APACHE scores, the elderly, and those with severe renal impairment. And, in clinically evaluable patients with VAP, the cure rate was 80% for telavancin compared with 68% for vancomycin."
"We believe that this was the largest double-blind, randomized, clinical program ever conducted in patients with Gram-positive HAP, and included the most patients infected with MRSA," said Michael Kitt, M.D., Senior Vice President of Development at Theravance. "These early results are from a very robust dataset and we look forward to presenting additional analyses as our understanding evolves."
Analysis of the safety database showed that 82% of telavancin-treated patients and 81% of those who received vancomycin experienced one or more treatment-emergent adverse events. The most common adverse events were diarrhea, constipation and anemia, which all occurred at similar incidences in both treatment groups. Additionally, the incidence of renal adverse events was similar in the telavancin (10%) and vancomycin (8%) treatment groups. With regard to changes in the QTc interval, there were similar proportions of patients in each group who experienced a post-baseline maximum value of greater than 500 milliseconds or a maximum change from baseline of greater than 60 milliseconds.
"In addition to the robust outcome data, we were pleased with the safety and tolerability of telavancin in this vulnerable patient population," stated William E. Fitzsimmons, Pharm.D., Senior Vice President, Research and Development at Astellas Pharma US, Inc., an affiliate of Astellas Pharma Inc., the worldwide business partner for the development and commercialization of telavancin. "We are excited about the results of the ATTAIN 1 and ATTAIN 2 studies and look forward to working with Theravance in bringing this potential new treatment to patients."
Program Design
The HAP program consisted of two large, multi-center, multinational, double-blind, randomized Phase 3 clinical studies, ATTAIN 1 and ATTAIN 2, in which 1,503 patients were enrolled and treated, 464 of whom were infected with MRSA. Patients with HAP suspected or proven to be caused by Gram-positive bacteria were randomized (1:1) to receive either telavancin 10 mg/kg IV once daily or vancomycin 1 g IV every 12hr (the protocols allowed vancomycin dosage to be optimized per site-specific guidelines). For patients with suspected or proven polymicrobial infections involving Gram-negative and/or anaerobic bacteria in addition to the Gram-positive organisms for which study medication therapy was used, aztreonam, piperacillin-tazobactam, and/or metronidazole was allowed. The objective of each study was non-inferiority of telavancin versus vancomycin in clinical cure rate at the test-of-cure visit. The program also included a key objective of superiority in clinical cure rate of telavancin versus vancomycin in the pooled patients with MRSA infections from ATTAIN 1 and ATTAIN 2. Determination of clinical cure was based upon physician-judged resolution of clinical signs and symptoms of HAP.
Conference Call and Webcast Information
The company has scheduled a conference call to discuss this announcement today at 5 p.m. Eastern Standard Time. To participate in the live call by telephone, please dial 888-778-8914 from the U.S., or 913-312-0399 for international callers. Those interested in listening to the conference call live via the internet may do so by visiting the company's web site at www.theravance.com. To listen to the live call, please go to the web site 15 minutes prior to its start to register, download, and install any necessary audio software.
A replay of the conference call will be available on the company's web site for 30 days through January 4, 2008. An audio replay will also be available through 11:59 p.m. Eastern Standard Time on December 19, 2007 by dialing 888-203-1112 from the U.S., or 719-457-0820 for international callers, and entering confirmation code 6825479. |
