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NIH Grants Phylonix Phase II SBIR to Develop High-Throughput In vivo Zebrafish Assays
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Phylonix Pharmaceuticals, Inc. has announced that it has been awarded a $1,250,369 Phase II Small Business Innovation Research Grant (SBIR) from the National Institute of General Medical Sciences of the National Institutes of Health (NIH) to develop in vivo zebrafish assays for assessing drug effects on Cytochrome (CYP) P450s. CYP profiling, a critical step in drug development, is required by the Food and Drug Administration (FDA) for all new drug approvals.
“This grant, ’Zebrafish Cytochrome P450 Assays for Assessing Drug Metabolism and Drug Safety,’ will support the Phylonix research program for assessing potential drug-to-drug interactions (DDIs) during preclinical research,” commented Patricia McGrath, Phylonix President and Chief Executive Officer.
“A rapid and robust whole zebrafish CYP assay, amenable to automation in multiwell plate formats, will accelerate drug metabolism and safety profiling and reduce the possibility of costly late-stage drug development failures or product market withdrawal after commercialization,” she continued.
Background on the Technical Approach
Many clinically relevant drug-to-drug interactions (DDIs) are associated with inhibition and/or induction of a CYP enzyme, such as 3A4. Modification of CYP activities can profoundly affect therapeutic efficacy and lead to life-threatening toxicity. Examples of costly high-profile drug withdrawals due to CYP-related DDIs include the antihistamines terfenadine and astemizole, the antihypertensive mibefradil and statins such as cerivastatin.
A validated, simple in vivo CYP assay will be useful for profiling drug metabolism prior to performing mammalian testing. Because of their genetic and physiological similarity to humans, zebrafish have been shown to be an efficient, predictive animal model for assessing drug metabolism and drug safety.
“This grant, ’Zebrafish Cytochrome P450 Assays for Assessing Drug Metabolism and Drug Safety,’ will support the Phylonix research program for assessing potential drug-to-drug interactions (DDIs) during preclinical research,” commented Patricia McGrath, Phylonix President and Chief Executive Officer.
“A rapid and robust whole zebrafish CYP assay, amenable to automation in multiwell plate formats, will accelerate drug metabolism and safety profiling and reduce the possibility of costly late-stage drug development failures or product market withdrawal after commercialization,” she continued.
Background on the Technical Approach
Many clinically relevant drug-to-drug interactions (DDIs) are associated with inhibition and/or induction of a CYP enzyme, such as 3A4. Modification of CYP activities can profoundly affect therapeutic efficacy and lead to life-threatening toxicity. Examples of costly high-profile drug withdrawals due to CYP-related DDIs include the antihistamines terfenadine and astemizole, the antihypertensive mibefradil and statins such as cerivastatin.
A validated, simple in vivo CYP assay will be useful for profiling drug metabolism prior to performing mammalian testing. Because of their genetic and physiological similarity to humans, zebrafish have been shown to be an efficient, predictive animal model for assessing drug metabolism and drug safety.
