NeRRe Therapeutics is a clinical-stage company developing the neurokinin(NK)-1 receptor antagonist orvepitant for the treatment of common, chronic, and debilitating conditions caused by neural hypersensitivity associated with Substance P/ NK-1 receptor system dysfunction.
Our focus with orvepitant is on the disabling chronic cough associated with the rare and terminal lung disease idiopathic pulmonary fibrosis (IPF) for which there is no approved treatment.
A Phase 2b study (VOLCANO-2) in patients with refractory or unexplained chronic cough (RUCC) has been completed. This study demonstrated that orvepitant 30 mg once daily resulted in rapid and sustained improvements in several clinically relevant patient reported outcome (PRO) assessments of cough burden, providing a clear proof of concept for the benefit of orvepitant as a treatment for chronic cough.
In the VOLCANO-2 study there was no effect on cough frequency in the full analysis set, but the 30 mg dose was significant or trending towards significance in subjects with higher cough frequencies at baseline. A similar observation has now been made and reported in several other studies in chronic cough. The body of evidence suggests that at lower cough frequencies the signal to noise ratio limits the ability to discern a change in frequency and highlights a significant limitation of cough frequency as a study endpoint.
NeRRe will now evaluate orvepitant as a treatment for chronic cough in patients with IPF, a rare, progressive, and fatal form of interstitial lung disease in which cough is a dominant and distressing feature, that decreases patient quality of life, is a marker of increased disease severity, and may predict its progression¹. Effective treatments for IPF cough are urgently needed.