DEVELOPMENT AND QUALIFICATION OF A BIOMARKER FOR PRECLINICALLY IDENTIFYING THE PRO-ARRHYTHMIA RISK OF DRUGS BASED ON CONTRACTILITY MEASUREMENTS CONDUCTED IN HUMAN ADULT PRIMARY CARDIOMYOCYTES

Information

  • Research Project
  • 9989724
  • ApplicationId
    9989724
  • Core Project Number
    U01FD006879
  • Full Project Number
    1U01FD006879-01
  • Serial Number
    006879
  • FOA Number
    RFA-FD-19-028
  • Sub Project Id
  • Project Start Date
    9/1/2019 - 5 years ago
  • Project End Date
    8/31/2020 - 4 years ago
  • Program Officer Name
    SIMPSON, IDELLA
  • Budget Start Date
    9/1/2019 - 5 years ago
  • Budget End Date
    8/31/2020 - 4 years ago
  • Fiscal Year
    2019
  • Support Year
    01
  • Suffix
  • Award Notice Date
    9/3/2019 - 5 years ago
Organizations

DEVELOPMENT AND QUALIFICATION OF A BIOMARKER FOR PRECLINICALLY IDENTIFYING THE PRO-ARRHYTHMIA RISK OF DRUGS BASED ON CONTRACTILITY MEASUREMENTS CONDUCTED IN HUMAN ADULT PRIMARY CARDIOMYOCYTES

PROJECT SUMMARY Current strategies for cardiac safety evaluation of drugs have shown significant limitations. Over the past several years, the FDA and pharmaceutical industry have promoted initiatives to develop more predictive human-relevant preclinical platforms to rectify this problem. In this context, AnaBios established an adult human primary cardiomyocyte contractility model, which has the potential to predict drug-induced pro- arrhythmia risk. The correlation between electrical (action potential, AP) and mechanical (contraction) abnormalities, is a consequence of the tight functional coupling between these two processes in adult cardiac cells and tissues. As a result, drug-induced ventricular repolarization irregularities also lead to severe contractility abnormalities. In line with these observations, AnaBios has developed an adult human primary ventricular cardiomyocyte contractility model that simultaneously evaluates pro-arrhythmia risks from the measurement of drug-induced changes in several parameters that are derived from the kinetics of the contractility transient; AnaBios is further combining the parameters into a single biomarker that can be used to predict pro-arrhythmia risk in advance of clinical studies. AnaBios aims to qualify the biomarker derived from the contractility measurements, which will provide critical information for drug developers and regulators with respect to the cardiac risk of drugs at the preclinical stages of drug development.

IC Name
FOOD AND DRUG ADMINISTRATION
  • Activity
    U01
  • Administering IC
    FD
  • Application Type
    1
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
    247461
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
    103
  • Ed Inst. Type
  • Funding ICs
    FDA:247461\
  • Funding Mechanism
    Non-SBIR/STTR RPGs
  • Study Section
    ZFD1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    ANABIOS CORPORATION
  • Organization Department
  • Organization DUNS
    963422196
  • Organization City
    SAN DIEGO
  • Organization State
    CA
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    921095754
  • Organization District
    UNITED STATES