Shares in Spain’s Laboratorios Farmaceuticos Rovi are sinking this morning after its investigational diabetic foot ulcer drug Nautiol failed in a late-stage trial.

The Madrid-headquartered drugmaker says that data from a Phase III trial of Nautiol (bemiparin) does not show that the drug is a better treatment than placebo. In the study, 329 patients randomly received daily subcutaneous injections of bemiparin or placebo, and for the primary efficacy endpoint, the complete healing or improvement of the ulcer, there was no statistically significant difference in the Rovi drug group (66.1%) to placebo (65.8%).

Chief executive Juan Lopez-Belmonte noted that “the results do not confirm the positive data that we obtained in an earlier trial”, adding that “we are particularly aware of the disappointment that this may cause to diabetic patients”. He added that “there is a clear need to develop more effective treatments” to prevent foot ulcers “from being the leading cause of non-traumatic amputations”.

Javier Martínez, director of clinical development at Rovi, said the company is working with the steering committee of the trial to review and interpret these results. Nevertheless, he added, the data confirm the good safety profile of bemiparin.

Mr Lopez-Belmonte said that Rovi will decide “within a few weeks” about what are the next steps to take in its research programme for bemiparin, a low molecular weight heparin, for diabetic foot ulcers. The drug is already available as an antithrombotic, sold as Hibor, and brought in 11 million euros (+13%) for the first quarter, out of total turnover of 33.3 million euros (+11%)

Investors seem to have made up their minds, however, and at 11.15am (UK time), Rovi shares were down 15.9% to 5.08 euros.