Pharm-Olam has been handed a Department of Defense (DOD) contract to run a mid- to late-stage trial of blockbuster autoimmune and inflammation drug adalimumab.
Better known as AbbVie’s Humira, the drug has a host of indications from Crohn’s disease and plaque psoriasis to rheumatoid arthritis and ankylosing spondylitis. It’s a huge moneymaker and the biggest-selling drug in the world, with around $15 billion in annual sales (although it's now falling under patent threats).
Now, the government is looking to tap the fully human IgG1 monoclonal antibody that binds to tumor necrosis factor alpha to help certain COVID-19 patients and guard against an unwanted inflammatory response, which can lead to more severe cases.
Pharm-Olam will help run the phase 2/3 trials via the U.S. DOD's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND). The Houston-based CRO is working under a $36.3 million agreement with the JPEO-CBRND to run the adaptive, outpatient study.
A number of repurposed drugs have been targeting COVID-19 and its tendency to invoke a severe inflammatory response or to help boost survival rates. But many, including AstraZeneca’s blood cancer med Calquence and IL-6 inhibitors Actemra from Roche and Kevzara from Sanofi and Regeneron, have tried and failed in similar tests. Pharm-Olam and the DOD will hope to have better luck with adalimumab.
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“We are pleased to have been selected by the DOD to conduct this important clinical trial and support the development of countermeasures to help those infected by COVID-19," said Jamie Sischo, Pharm-Olam’s vice president of government programs.
“The adalimumab COVID Therapeutic Trial will test the safety and efficacy of a treatment for pandemic sufferers. Further, this agreement expands our dedication and commitment to slowing and stopping the effects of COVID-19 and adds to our growing portfolio of federally funded clinical trials, including support for Operation Warp Speed.”