Technology

Surrogate biomarkers, functional validation and beyond: a comprehensive platform for predicting efficacy and safety

Technologies

The current focus in drug development for cardiovascular and metabolic diseases is on new therapeutic classes that will offer:

  1. New mechanisms of action for better control of glycaemia, obesity, dislipidemia and cardiac function, in ways complementary to existing drugs,
  2. A complementary spectrum of efficacy on cardiovascular disorders associated with metabolic diseases, aiming to reduce major causes of premature morbidity and mortality in these at-risk populations.

Whatever the therapeutic goal, it is now critical to assess efficacy and safety on clinically relevant platforms measuring all parameters and mechanisms associated with cardiovascular and metabolic diseases.

Physiogenex has developed several original functional platforms which focus on biomarker functionality and mechanisms. Beyond classical surrogate endpoints, biomarker functional properties are directly predictive of cardiovascular and metabolic diseases.

  • Transversal platform incorporating all aspects of metabolic and cardiovascular diseases

    Platforms analyzing efficacy and safety on body weight, insulin resistance, insulin secretion, hypertension, cardiovascular dysfunctions, dislipidemia, inflammation and hepatic steatosis represent a unique tool for compound selection, optimization and candidate prioritization. This approach can identify adverse effects that can help to predict potential side-effects, additional efficacy and the safety of drug candidates.

  • Radiotracers and kinetic studies: Original tools to predict your competitive advantage and clinical effects:

    Mechanistic information provided by kinetic studies overcome the limits of classical surrogate biomarkers for predicting clinical efficacy. Unlike plasma variables, kinetics are similar in different species. Contrary to classical surrogate endpoints, kinetic studies focus on functions and mechanisms which are directly involved in metabolic and cardiovascular diseases.
    Accordingly, Physiogenex's in vivo individual-tissue techniques using radiotracers provide critical information on the target-organ distribution of your compound. By evaluating the tissue by tissue impact of your drug candidate in vivo, you will obtain strong efficacy data, identify suspected off-target effects, determine additional efficacy and/or identify adverse effects that would not otherwise have been seen at the preclinical stage   

Physiogenex’s platforms provide strategic data for determining your competitive advantage and for rapid decision-making. Moreover, these techniques can be extremely useful for stratifying heterogeneous patient populations, and for selecting the most relevant cellular/ex vivo screening tests.


Physiogenex platforms have been developed  to meet industry needs for improving the discovery and preclinical process:

  1. Ex vivo/in vivo techniques which can be used for rapid and predictive proof of concept and for large-scale screening,
  2. In vivo techniques which provide strategic key data for clinical development as early as the preclinical stage.
Sensitivity and informative advantages of radiotracers: significant effects on plasma variables do not necessarily reflect effects of your medicine
None significant effects on plasma variables do not necessarily reflect functional effects of your medicine
None significant effects on plasma variables do not necessarily reflect functional effects of your medicine
Advantage of in vivo-individual tissue techniques:
Identify suspected off-target effects or determine additional efficacy
(Experimental design performed to evaluate individual in vivo tissue glucose uptake)
In vivo measures on crucial tissues to identify effects that would not otherwise have been seen at the preclinical stage
In vivo measures on crucial tissues to identify effects that would not otherwise have been seen at the preclinical stage
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