Since the start of the COVID-19 pandemic, Labcorp has worked tirelessly to provide the kind of cutting-edge diagnostics and drug development breakthroughs that improve health and improve lives.
Labcorp’s very own clinical research unit (CRU) in Leeds, U.K., recently helped to accelerate clinical trials of one such breakthrough: Ridgeback Biotherapeutics’ and Merck’s Molnupiravir.
What is Molnupiravir?
Molnupiravir is a ribonucleoside analogue with direct-acting antiviral activity against a number of RNA viruses, including SARS-CoV-2, the virus that causes COVID-19.
The oral antiviral was recently approved under a Conditional Marketing Authorization by the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) as a treatment for mild to moderate COVID-19 in non-hospitalized adults at risk of developing severe disease.
Molnupiravir is currently under review by the U.S. Food and Drug Administration (FDA) for the same use case. Merck has supply and purchase agreements in place worldwide to quickly and widely distribute treatment once authorized.
Accelerating the Molnupiravir clinical trials, by the numbers:
Our work at the Leeds CRU allowed Merck and Ridgeback Biotherapeutics to quickly advance through early-phase clinical trials safely, responsibly and in full regulatory compliance.
Combining in-house multidisciplinary teams, thorough contingency planning, resilient protocols and cutting-edge technology, researchers at the Leeds CRU sped along numerous elements of the Molnupiravir first-in-human trial.
Regulatory submissions, pharmacy and bioanalytical laboratory setup, and volunteer recruitment are just a few of the processes our Leeds CRU helped to accelerate.
“This team developed a protocol with the sponsor team in a matter of days that normally would have taken several weeks, and submitted initial documents to the regulators,” said Jim Bush, Vice President, Medical at Labcorp, Clinical Pharmacology Services. “It was unbelievably collaborative.”
Just how much did the Leeds CRU accelerate this trial? Let’s take a look:
- 20 Days to bring together our multidisciplinary team, finalize regulatory submission documents, attain full ethics and clinical trial approvals, and begin subject screening
- 7 Days to establish a pharmacy setup (Typically 2-3 months)
- 14 Days to establish bioanalytical setup (Typically 6-8 weeks)
- 9.5 Weeks to enable Phase II trials (Typically 33 weeks)
- 23 Days from initial phone conversation with sponsor to first-in-human dose
- 16 Weeks for completion all dosing cohorts (Typically 46 weeks)
Though vaccines continue to be safe and effective tools in our fight against COVID-19, no vaccine is 100% effective. That’s why antiviral therapies like Molnupiravir remain a crucial need, especially for high-risk adults. Labcorp is honored to have played a part in accelerating Merck’s clinical trials and helping speed this potentially life-saving drug to market.
Contact us or explore our clinical trial services to learn more about how we can help you optimize protocol design, accelerate trial recruitment and more.
Take a deeper dive
Want to dig into the finer details of the research conducted in these clinical trials? A number of publications have resulted from the trials, co-authored by Labcorp’s own Oren Cohen, M.D. and Jim Bush MB.ChB. Explore them here!
Human safety, tolerability, and pharmacokinetics of molnupiravir, a novel broad-spectrum oral antiviral agent with activity against SARS-CoV-2
Developing a direct acting, orally available antiviral agent in a pandemic: the evolution of molnupiravir as a potential treatment for COVID-19
Accelerated first-in-human clinical trial of EIDD-2801/MK-4482 (molnupiravir), a ribonucleoside analog with potent antiviral activity against SARS-CoV-2