Trevena has announced positive results from a proof-of-concept clinical trial during which its new AT1 receptor-selective agonist, TRV027, was found to be well-tolerated in Covid-19 patients who have been hospitalised.
TRV027 is being evaluated as a potential therapy for treating acute lung injury that leads to acute respiratory distress syndrome (ARDS) and abnormal blood clotting in patients suffering from Covid-19.
As per the trial data, TRV027 showed preliminary proof of its potential to boost biomarker and clinical endpoints associated to disease severity and advancement.
The trial was funded and led by Imperial College London in the UK.
The trial also secured additional support through the British Heart Foundation Imperial Centre for Research Excellence Award.
The trial’s primary goal was mean change from baseline D-dimer levels at three days.
D-dimer servers as biomarker to evaluate the risk of abnormal clotting in vascular system.
The increase in circulating D-dimer in patients suffering from Covid-19 is known to be an accurate predictor of critical disease advancement and mortality.
Almost 70% of the subjects getting TRV027 had a decline in circulating D-dimer when compared with 27% in the placebo arm.
Additionally, TRV027 was associated to a 92% probability of a potential advantageous therapy effect based on a Bayesian model analysis suggested by the Data Monitoring and Safety Committee (DMSC) of the study.
In a post-hoc analysis, it was found that subjects in the TRV027 arm had a 12-day reduction in the average length of hospital stay as against placebo while the median reduction stood at four days.
Trevena CEO president and Carrie Bourdow said: “I am pleased to announce the results from this analysis, which provide initial evidence of the therapeutic potential of TRV027 to improve Covid-19 patient outcomes.
“With the ACTIV and REMAP-CAP Covid-19 platform trials currently evaluating TRV027, and data expected as early as mid-2022, we look forward to building upon these promising results.”
In March, the DMSC evaluated the data in March this year and found no safety or efficacy concerns, and therefore, recommended advancing TRV027 to a larger and wider trial with clinical efficacy outcomes.
Furthermore, the DMSC advised closing subject recruitment at the interim analysis enrolling almost 30 patients prior to reaching the target needed to analyse statistically significant therapy differences.
TRV027 is presently being evaluated in two multi-site, multi-arm efficacy studies – ACTIV-4 Host Tissue trial in the US as well as REMAP-CAP trial in the UK.