The molecule studied, known as rEV131 is a recombinant version of a naturally occurring molecule identified in ticks, parasites whose saliva contains immuno-suppressive and immuno-modulatory molecules.
The trial achieved a statistically significant difference in the mean sum of symptom scores at 15 minutes post allergen challenge in the 62 patients who completed the trial according to the protocol.
rEV131 showed a dose-dependent drug effect enabling Evolutec to select the optimum dose for further work to determine the onset of action and the duration of effect. There were no significant adverse events and rEV131 was found to be comfortable and well-tolerated.
This result shows that rEV131 has an onset of action of 45 minutes or less – faster than steroid nasal sprays, which have an onset of action of approximately eight hours. The main effects of rEV131 were against congestion and mucus production – symptoms that patients find the most troublesome and which are not well addressed by oral antihistamines. The rapid onset of action and efficacy against congestion and mucus underpin the potential commercial advantages of rEV131.
Mark Carnegie Brown, Evolutec’s CEO, commented: “This result highlights the potential of rEV131 in the $6 billion allergic rhinitis market. We now intend to undertake a multi-dose phase II study to define further the onset and duration of action which will guide commercial positioning.”