PRINCETON, NJ – Sept. 25, 2015 –Certara®, the global biosimulation technology-enabled drug development company, today announced that it partnered with the Critical Path to TB Drug Regimens (CPTR) to develop a tuberculosis (TB) biomarker in Phase II which was predictive of durable cure in Phase III. Their meta-analysis was presented at the 8th International Workshop on Clinical Pharmacology of TB Drugs, and the American Society for Microbiology’s (ASM’s) Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) conference. Both meetings which were held at the San Diego Convention Center, CA from Sept. 17–21.
Their presentation was entitled, “Quantitative Modeling of Time to Positivity Following Dosing of Bedaquiline and Rifafour in Patients with Pulmonary TB Infection.”
The team conducted a meta-analysis of 10 Phase II studies with more than 1,700 patients using non-linear mixed-effects modeling. They identified time to detection (TTD), also known as time to positivity (TTP), or the time to reach detectable growth of Mycobacterium tuberculosis (Mtb) in culture, as an important measure of patient progress during TB therapy.
“Determining a link between an early biomarker measurement in Phase II, such as TTP, and long-term clinical outcomes in Phase III may help to reduce the time required to develop a new TB drug regimen from decades to years,” said JF Marier, PhD, FCP, vice president and lead scientist at Pharsight, a Certara Company. “For example, a dose-ranging study could be used to determine early changes in TTP in Phase II, predict their effect on long-term clinical outcome in Phase III, and guide decisions. It could also reduce the size and cost of clinical trials for TB therapies by shortening the duration of those trials.”
CPTR is a collaborative initiative established to help address the scientific, clinical, regulatory and legal challenges posed by focusing on development of novel drug combinations rather than single agents.
Certara also collaborated with Merck and the Novartis Institutes for BioMedical Research on an ICAAC poster describing their modeling and simulation work with the antibiotic daptomycin in patients ranging in age from neonates to adolescents. The poster was entitled, “Population Pharmacokinetics and Dose Justification of Daptomycin in Pediatric Patients With Complicated Skin and Skin Structure Infections (cSSSI).”
The pharmacokinetics (PK) of daptomycin in adults is well understood. As the number of multidrug-resistant Gram-positive infections in children is increasing, pediatric patients need new treatment options. This is a challenge because children can differ from adults in their drug metabolism or clearance. An early clinical trial of daptomycin showed that, when children were given adult daptomycin dosing regimens, the area under the curve and maximum concentration measurements were not equivalent to those in adults. This difference resulted in overly low drug exposures.
“We conducted a population PK analysis using all the available PK data collected from four pediatric clinical trials of daptomycin,” said Certara Director of Pharmacometrics Samer Mouksassi, PharmD, PhD, FCP. “As a result, we were able to determine an effective daptomycin dose regimen to treat cSSSI in children in different age groups.”
For more information about this conference, please visit http://www.icaac.org.
Certara is a global biosimulation technology-enabled drug development company. Its customers include hundreds of biopharmaceutical companies around the globe, together with several regulatory agencies. Certara’s solutions, which span the discovery, preclinical and clinical stages of drug development, enable superior drug development and regulatory decision-making through biosimulation, thus increasing R&D productivity and commercial value. For more information, visit www.certara.com.
Ellen Leinfuss, 609-216-9586
Chief Marketing Officer
Lisa Osborne, 206-992-5245
Rana Healthcare Solutions