At Gene PreDiT we believe that every disease and its treatment should be as personalized as possible, and that each patient should have the best treatment according to its condition.It is known that not only each disease has multiple causes, but also that different individuals have different symptomatology and respond differently to the same treatment. It is estimated that only 40% of currently available medications have significant beneficial effects. Therefore it is essential to identify new biomarkers that allow the stratification of patients, in order to develop more effective, customized therapies.
Gene PreDiT is dedicated to the development of research platforms to identify new genes relevant to certain diseases and identification of compounds with biological activity. Our strategy relies on the usage of Drosophila melanogaster, the fruit fly, as a model organism. Its use as an animal model for targeted drug discovery has been limited, but the high conservation to the human genome, the fact that are innumerous genetic tools available and its reduced cost (among other reasons), represent a clear potential that needs to be explored.
Additionally, the genesand compounds identified in Drosophila are validated in human patients. Thus, Gene PreDiT research platforms combine in silico and in vivo approaches.
Moreover, since developing new drugs takes an enormous amount of time, money and effort, Gene PreDiT is focused in a strategy of drug reprofiling or drug repurposing in order to reduce time frame and costs, along with improve success rates. Many drugs approved for other uses have already been tested in humans, so exhaustive information on their pharmacology, pharmacokinetics and toxicology is available.
As a result, the GenePreDiT platforms represent an innovative strategy to address the urgent need of bringing novel therapies for conditions currently with unmet needs. Moreover, we believe our platforms can be used to identify novel biomarkers and new therapeutic strategies that allow for the development of personalized and more effective therapies. In particular we believe that our approach can be extremely helpful in the stratification of patients in clinical trials. For that purpose, the genes and compounds identified in Drosophila are validated in human patients.
Currently, Gene PreDiT is conducting a Phase IIa clinical trial for a genetic marker and a targeted therapy for obesity. The rationale behind this study is that certain nucleotide polymorphisms (SNPs) of GP0044 gene may predispose overweight or obese people to lose body fat mass and weight after treatment with the compound GPP846. The study GPD-01-01 is interventional and will consist of 2 ambulatory periods and 4 visits (V): a run-in period of at least 4 weeks (V1 to V2) and a 12-week pharmacological treatment period (V2 to V4). The primary objective is to evaluate the interest of GP0044 genotyping as a predictive biomarker of body weight and fat mass reduction after treatment with GPP846. The primary endpoint will be the proportion of patients who will lose at least 3% (response rate) of body weight from end of the run-in period (V2) to week 12 of the treatment period (V4). The secondary objectives are to evaluate the effect of GPP846 in body weight and fat mass reduction in patients with different GP0044 genotypes/SNPs (phenotyping), the effect of GPP846 in waist circumference, waist/hip ration an BMI, as well as the tolerability and safety of the drug in the study population.
