Xceleron Inc Executes Agreement With Neurocrine Biosciences, Inc. For Multi-Arm Microdose Study
Gaithersburg, MD: Xceleron, the global leader for zeptobiology analysis in the field of drug development, announced today an agreement for a multi-arm Phase 0 microdose study with Neurocrine Biosciences (NASDAQ: NBIX), a biopharmaceutical company focused on neurological and endocrine-related diseases and disorders. The purpose is to evaluate preliminary pharmacokinetics (PK) and metabolism of five compounds and rank order them based on their respective PK profiles.
“Partnering with Xceleron to bring our drug candidates into clinical development early in the development process provides Neurocrine with significant benefits in terms of additional candidate selection as well as reduced risk and cost,” said Haig Bozigian, Ph.D., Neurocrine Biosciences’ Vice President, Pre-Clinical Development. “While our lead compound is being evaluated in clinical studies, microdose studies will provide additional valuable comparative pharmacokinetics and bioavailability for our back-up compounds.”
Xceleron will conduct clinical trials in Europe with accelerator mass spectrometry (AMS) analysis completed at the Company’s GLP accredited laboratories in York, UK. Over the course of the 14-day, crossover design trial, five parallel groups of four healthy volunteers will receive oral and intravenous administrations of one of five drug candidates.
“Our ultra-sensitive capability for drug and metabolite analysis is radically changing the interface between preclinical and clinical trial stages,” said Scott Tarrant, Xceleron’s Vice President Business Development. “Companies like Neurocrine, who utilize Phase 0 microdose studies may benefit from this approach by obtaining early clinical data as a means of candidate selection. This represents a significant advancement in drug development and demonstrates the true value of our approach and technology.”
About Xceleron Xceleron is the only good laboratory practices (GLP) – accredited biomedical facility in the world with unique expertise in the field of zeptobiology – ultra-sensitive drug and metabolite analysis using accelerator mass spectrometry (AMS). AMS enables the pharmacokinetic (PK) measurement of absorption, distribution, metabolism and excretion of drugs administered to humans in microdose quantities. The company’s approach facilitates Phase 0 early human trials to identify the metabolic fate of a drug at the single molecule level. To date, studies have consistently shown data linearity between Phase 0 microdosing and traditional Phase I PK measures. Xceleron’s technology offers streamlined clinical development with combined Phase I and mass balance studies, early detection of human specific metabolites, and absolute bioavailability studies which measure drug levels of simultaneously administered IV and oral doses in the same patient. More information can be obtained at www.xceleron.com.
About Neurocrine Biosciences Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company focused on neurological and endocrine-related diseases and disorders. Our product candidates address some of the largest pharmaceutical markets in the world including insomnia, anxiety, depression, various female and male health disorders, diabetes, irritable bowel syndrome, eating disorders, pain, and autoimmunity disorders. More information can be obtained at www.neurocrine.com.