The phase II trial will comprise a double blind, placebo-controlled study in 52 patients, with the option to end the trial after treatment of 26 patients if interim results are statistically significant. The clinical endpoints of the study are safety and therapeutic efficacy and the study will be carried out in three clinical centers in the Netherlands.
Results from the phase I trial show that the product is safe and was well tolerated. In addition, 12 out of 16 patients also showed either full recovery or significant improvement after the two-week therapy, which gives a promising early indication of the efficacy of OP-145.
“These are very encouraging results for OP-145 proving that our product is not only safe and well-tolerated but also showing extremely promising signs for its efficacy,” said Dr Joost Holthuis, CEO of OctoPlus.
OP-145 is a novel peptide product that has a unique mechanism of action. It neutralizes the bacterial toxins that often keep chronic middle ear infections active. The drug offers potential benefits to patients with chronic middle ear infection that do not respond to currently available antibiotics and thereby require surgical intervention.
The compound is a co-development project between OctoPlus and Leiden University Medical Center.