Promising efficacy with Evolva's EV-077, but a safety signal needs clarification, say Edison analysts

Phase IIa data on Switzerland-based Evolva’s (SIX: EVE) EV-077 indicate that it has significant potential in treating the complications of diabetes, if a safety concern can be overcome, comment analysts at Edison Investment Research.

Data from this trial and on related drugs suggest a lower dose of EV-077 should resolve the issue and still be efficacious. Promising preclinical data on the EV-035 antibacterial products could lead them to being out-licensed. Progress with the vanilla and stevia projects means they might be partnered in the next six months. The analysts value Evolva at 215 million Swiss francs ($230.5 million).

Interim results from the Phase IIa study in diabetics with EV-077 show that it has the potential to treat a number of complications associated with diabetes. However, a safety signal (raised levels of liver enzymes) was also observed. PK/PD analysis and read-across from related drugs suggest that a lower dose should still be efficacious without elevating liver enzymes levels. There are discussions with the German regulator BfArM to amend the current Phase IIa trial protocol to include lower doses.