Achieves Steady-State With No Observable Accumulation After 8 Weeks of Dosing
CHICAGO, Il, USA I April 29, 2013 I Durata Therapeutics, Inc. (DRTX) today announced data from a Phase 1 study of its lead product candidate, dalbavancin, under investigation for the treatment of susceptible gram positive bacterial infections including MRSA. The data, presented at the 23rd Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), demonstrate that dalbavancin, when administered to healthy subjects as an IV infusion weekly for a total of up to 8 weeks, was well tolerated.
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Weekly Doses of Intravenous Dalbavancin in Healthy Subjects Authors: M. Dunne, C. Sprenger, S. Moriarty (Branford, US) Poster #: P910
Study conclusions: Dalbavancin was well-tolerated when administered IV as a loading dose of 1000 mg followed by 500 mg weekly for a total of up to 8 weeks. With a loading dose of 1000mg on Day 1, the 500 mg weekly dose achieves steady-state by Day 8 with no observable accumulation. This dosing regimen of dalbavancin should be considered for further study in clinical indications which require longer duration of therapy, such as osteomylelitis.
Further Study Details
This was a single center, open-label, multiple-dose, safety, tolerability, and PK study of increasing dosing durations. The total sample size for this study was 18 subjects, divided into 3 dosing cohorts of 6 subjects each. All subjects were asymptomatic, non-smoking adult volunteers between the ages of 18 and 55. All subjects received 1000 mg IV on Day 1. Cohort 1 received subsequent 500 mg IV doses on Days 8, 15 and 22; Cohorts 2 received additional 500 mg IV doses on Days 29 and 36; and Cohort 3 received additional 500 mg doses on Days 43 and 50. Drug was administered over 30 minutes. Standard safety parameters were monitored throughout the study.
For the dalbavancin 500 mg IV dose given on the last day of dosing, the AUC (ug.h/mL) was 10202.82, 12992.79 and 12173.30 and the C-max was 160.00, 187.00 and 179.67 in Cohorts I, II and III respectively. The calculated elimination curve reflected the beta (β) T-1/2 of Dalbavancin of 99 to 109 hours. Steady state was achieved by Day 9 with no observable accumulation. No serious AEs were reported over the course of this study. The most common treatment emergent AE reported was mild pain in the extremity, reported by 2 subjects, without evidence of thrombophlebitis. No subject withdrew or was discontinued from the study. No laboratory abnormality was attributed to Dalbavancin.
A copy of this poster is available on Durata’s website: www.duratatherapeutics.com.
About Dalbavancin
Dalbavancin is an intravenous antibiotic product candidate under investigation for once-weekly dosing, which we believe may facilitate the treatment of patients with ABSSSI in both the in-patient and out-patient settings, potentially reducing the length of a patient’s hospital stay or avoiding hospital admission altogether, with an impact on the overall cost of care for these patients.
About Durata Therapeutics
Durata Therapeutics is a pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses. Durata has completed two global Phase 3 clinical trials with its lead product candidate, dalbavancin, under investigation for the treatment of patients with acute bacterial skin and skin structure infections, or ABSSSI.
SOURCE: Durata Therapeutics
Post Views: 165
Achieves Steady-State With No Observable Accumulation After 8 Weeks of Dosing
CHICAGO, Il, USA I April 29, 2013 I Durata Therapeutics, Inc. (DRTX) today announced data from a Phase 1 study of its lead product candidate, dalbavancin, under investigation for the treatment of susceptible gram positive bacterial infections including MRSA. The data, presented at the 23rd Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), demonstrate that dalbavancin, when administered to healthy subjects as an IV infusion weekly for a total of up to 8 weeks, was well tolerated.
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Weekly Doses of Intravenous Dalbavancin in Healthy Subjects Authors: M. Dunne, C. Sprenger, S. Moriarty (Branford, US) Poster #: P910
Study conclusions: Dalbavancin was well-tolerated when administered IV as a loading dose of 1000 mg followed by 500 mg weekly for a total of up to 8 weeks. With a loading dose of 1000mg on Day 1, the 500 mg weekly dose achieves steady-state by Day 8 with no observable accumulation. This dosing regimen of dalbavancin should be considered for further study in clinical indications which require longer duration of therapy, such as osteomylelitis.
Further Study Details
This was a single center, open-label, multiple-dose, safety, tolerability, and PK study of increasing dosing durations. The total sample size for this study was 18 subjects, divided into 3 dosing cohorts of 6 subjects each. All subjects were asymptomatic, non-smoking adult volunteers between the ages of 18 and 55. All subjects received 1000 mg IV on Day 1. Cohort 1 received subsequent 500 mg IV doses on Days 8, 15 and 22; Cohorts 2 received additional 500 mg IV doses on Days 29 and 36; and Cohort 3 received additional 500 mg doses on Days 43 and 50. Drug was administered over 30 minutes. Standard safety parameters were monitored throughout the study.
For the dalbavancin 500 mg IV dose given on the last day of dosing, the AUC (ug.h/mL) was 10202.82, 12992.79 and 12173.30 and the C-max was 160.00, 187.00 and 179.67 in Cohorts I, II and III respectively. The calculated elimination curve reflected the beta (β) T-1/2 of Dalbavancin of 99 to 109 hours. Steady state was achieved by Day 9 with no observable accumulation. No serious AEs were reported over the course of this study. The most common treatment emergent AE reported was mild pain in the extremity, reported by 2 subjects, without evidence of thrombophlebitis. No subject withdrew or was discontinued from the study. No laboratory abnormality was attributed to Dalbavancin.
A copy of this poster is available on Durata’s website: www.duratatherapeutics.com.
About Dalbavancin
Dalbavancin is an intravenous antibiotic product candidate under investigation for once-weekly dosing, which we believe may facilitate the treatment of patients with ABSSSI in both the in-patient and out-patient settings, potentially reducing the length of a patient’s hospital stay or avoiding hospital admission altogether, with an impact on the overall cost of care for these patients.
About Durata Therapeutics
Durata Therapeutics is a pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses. Durata has completed two global Phase 3 clinical trials with its lead product candidate, dalbavancin, under investigation for the treatment of patients with acute bacterial skin and skin structure infections, or ABSSSI.
SOURCE: Durata Therapeutics
Post Views: 165
