September 13, 2011 -- Quotient Clinical, a business unit of Quotient Bioresearch (Quotient), today announced an agreement with UK-based biotech, Phico Therapeutics (Phico). Quotient will undertake a RapidFACTTM program to optimise nasal delivery of Phico’s SASPjectTM PT1.2, an antibiotic protein technology that offers a new approach for the treatment of serious life-threatening bacterial infections, including methicillin-resistant Staphylococcus aureus (MRSA).
RapidFACT will be used to screen alternative formulations designed to enhance nasal delivery, retention, and efficacy of SASPject in intranasal S. aureus carriers. RapidFACT exploits Quotient’s Translational Pharmaceutics™ platform to enable the rapid clinical screening and optimisation of drug products. Compared to conventional development processes, RapidFACT shortens project timelines and reduces active ingredient consumption by up to ~90 per cent, all of which combine to deliver significant cost savings. This is the first time that RapidFACT has been used to optimise nasal delivery, and is also the first time that it has employed a pharmacodynamics endpoint to guide formulation development.
Mark Egerton, MD of Quotient Clinical, commented: “We are delighted to be working with Phico on the SASPject technology. RapidFACT has been used on a wide variety of oral products and this is the first example of its use on a nasal product, demonstrating RapidFACT’s broad utility. It is also pleasing that we have been able to integrate Quotient’s specialist microbiological services into this project. We are looking forward to delivering an optimised drug product for the next stages of development, and helping Phico to accelerate its novel approach into patient studies.”
Dr Heather Fairhead, CEO of Phico commented: “This will be the second trial we have conducted with Quotient Clinical and we are very pleased to be working with the Quotient team again. We expect to benefit once more from their professional and helpful approach and the use of RapidFACT for this application is an added bonus which should save Phico time and money at this critical stage of clinical development with SASPject PT1.2.”
For more information on Quotient Clinical, please call UK +44 (0)115 974 9000, USA – 1-800-769-3518, email firstname.lastname@example.org or visit www.quotientbioresearch.com/clinical.
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About Quotient Clinical
Quotient Clinical is a leading provider of early development services. Its Translational Pharmaceutics™ platform offers a unique and streamlined process to reduce the time from First-in-Human studies to Proof-of-Concept by integrating flexible drug product manufacture into clinical trials
Drug product formulations can be efficiently optimised for downstream development using the RapidFACT™ service (Rapid Formulation development And Clinical Testing) in a process that significantly shortens timelines and saves significant money.
14C clinical studies can be provided as a fully integrated service using the flexible Synthesis-to-Clinic™ platform. Synthesis-to-Clinic enables all the processes involving 14C drug products, from synthesis of the 14C labelled drug molecule through to conduct of human clinical trials, to be undertaken with a single vendor and a single project manager throughout, delivering significant time and cost savings.
With a strong customer base across the United States, Europe and Japan, the goal of Quotient Clinical is to provide a unique and comprehensive range of early development services to pharmaceutical and biotechnology customers.
Quotient Clinical is a business unit of Quotient Bioresearch.
About Quotient Bioresearch
Quotient Bioresearch is a leading provider of early stage and specialist drug development services to life science clients worldwide. We provide tailored solutions for pharmaceutical, biotechnology and agrochemical clients, using state-of-the-art technologies underpinned by unparalleled medical, chemical and biological expertise. Our consultative, science-driven approach ensures the highest quality service to support and accelerate the development of your products. Our extensive range of capabilities spans Chemistry and Metabolism, Bioanalytical Sciences, and Clinical. These can be provided independently or integrated into bespoke work programmes.
For further information: www.quotientbioresearch.com
About Phico Therapeutics
Phico Therapeutics is a small biotech company based near Cambridge, UK. Phico has developed a unique antibacterial platform technology named SASPject. SASPject is effective against Gram-positive and Gram-negative bacteria, achieving in vitro kill rates exceeding other antibiotics. The technology uses delivery vectors to deliver anti-bacterial proteins that inactivate bacterial DNA. Phico’s first SASPject, for nasal decolonisation of S, aureus, including MRSA, has successfully completed a Phase I clinical trial with Phase II starting soon: both trials are funded by £1M from the Wellcome Trust. Early products focus on antibiotic resistant bacteria and broader spectrum SASPjects aimed at a range of Gram negative bacteria, including Pseudomonas aeruginosa, E. coli and Klebsiella pneumonia, are in development for inhaled and intravenous applications.