Certara applying expertise in clinical pharmacology, innovation and collaboration to accelerate potential prophylaxis for COVID-19
PRINCETON, NJ – 2020 年 5 月 7 日 – Certara®, the global leader in model-informed drug development, and DMTC (formerly the Defence Materials Technology Centre) Ltd, which works to enhance Australia’s defense and medical countermeasure capabilities, have entered into a research collaboration to evaluate the preventative use of chloroquine in health care workers at risk of infection from the novel coronavirus strain that causes COVID-19. Certara will support the DMTC-led clinical trial by analyzing study data to develop mathematical models to understand the viral time course and factors impacting drug exposure and prophylactic response in health care workers.
With no approved treatments for COVID-19, researchers across the globe are rapidly searching for safe and effective treatments for the disease. An oral prescription drug used for the treatment of malaria and certain inflammatory conditions, chloroquine has previously shown in vitro and experimental activity against related SARS-CoV-1 and has been hypothesized to be effective against SARS-CoV-2.
DMTC CEO Dr. Mark Hodge urged caution in the race to combat COVID-19. “Clinical trials are essential to establish global benchmarks and ultimately to prove a drug’s effectiveness,” said Dr. Hodge. “Repurposing an existing drug with a known safety profile has potential benefits in expediting conclusive results. In addition to our Australian partners in this trial, DMTC is harnessing the expertise of international partners like Certara to ensure that the clinical trial is complementary to other ongoing clinical trials across the globe.”
DMTC’s Chloroquine Chemoprophylaxis Countermeasure Against COVID-19 (C4) Study is a randomized, controlled study of healthy, adult healthcare workers drawn from military and civilian workforces, at risk of SARS-CoV-2 infection. Participation in the trial is entirely voluntary, subject to fully informed consent and strict admittance criteria.
C4 study participants will be randomized to receive a loading dose, followed by weekly doses of either chloroquine or a placebo, and will be carefully monitored and assessed over 14 weeks. Certara will analyze the data to conduct exposure-response research and build mathematical models to evaluate the relationship between chloroquine exposure and study endpoints.
“As COVID-19 continues to spread, we need to act quickly and efficiently to develop therapeutics for this global health crisis,” said Dr. Craig Rayner, president, integrated drug development at Certara. “We are honored to support the DMTC-led trial by providing our expertise in clinical pharmacology to help determine if chloroquine can be used as a preventative treatment for COVID-19 and as a much-needed prophylaxis for health care workers.”
Certara optimizes R&D productivity, commercial value and patient outcomes through its unique portfolio of model-informed drug development, regulatory science, and market access solutions. 過去6年間に米国 FDA が承認した新薬承認申請の90%以上をサターラのソフトウェアやサービスがサポートしています。Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries. For more information, visit www.certara.com.
DMTC develops and delivers technology and manufacturing solutions that strengthen Australian industrial capacity in areas identified as sovereign defence and national security priorities. DMTC outcomes are achieved through collaborative partnerships between Defence, government research agencies, Universities and industrial partners. Established in 2008, DMTC is a not for profit company limited by guarantee. For more information, visit www.dmtc.com.au.
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