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news.Quotient Clinical has entered into an agreement with German biotechnology company MediGene to undertake a rapid formulation development and clinical testing (RapidFACT) formulation development and clinical testing program on RhuDex, a new potential first-in-class treatment for rheumatoid arthritis and other inflammatory disorders.
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Quotient Clinical’s RapidFACT service exploits its integrated GMP manufacturing and clinical testing processes and facilities to enable the clinical evaluation of new drug formulations.
The company claims, compared to conventional development processes, RapidFACT enables shortening of project timelines and reduction of API consumption by ~90%.
MediGene will use the drug formulation selected in this program as the basis for the further clinical development of RhuDex.
Quotient Clinical MD Mark Egerton said RhuDex targets a novel mechanism and has the potential to become a new first-in-class therapy for rheumatoid arthritis.
"RapidFACT has now been employed across a wide selection of development projects, and we have secured strong data to validate the time and cost savings benefits that can be delivered to development project teams," Egerton said.
The agreement is subject to ethical and Medicines and Healthcare products Regulatory Agency (MHRA) approval.
Quotient Clinical, a provider of early development services, is a business unit of Quotient Bioresearch.
Quotient Bioresearch provides early stage and specialist drug development services to pharmaceutical, biotechnology and medical device clients worldwide through its three business units – Chemistry and Metabolism, Bioanalytical Sciences and Clinical.
MediGene focuses on clinical research and development of novel drugs against cancer and autoimmune diseases.