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news.OctoPlus has announced that efficacy of OP-145, a therapy for the treatment of chronic middle ear infection, was demonstrated in an interim analysis of the Phase II study. As a result, OctoPlus will close the study because its goal has been achieved.
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An independent data and safety monitoring board (DSMB) completed a formal interim analysis of safety and efficacy data from the Phase II study. The interim evaluation was executed as planned in the study protocol, and is based on data from 30 patients, which represents more than half of the planned total patient study group.
This interim analysis showed that treatment with OP-145 is safe and effective, with statistically significant improvement of otoscopic scores. As a result, the DSMB advised OctoPlus to close the study because clinical endpoints were achieved. OctoPlus will follow the recommendation of the board and close the study at this stage. Complete and final study results are expected to be available by the end of 2008.
Based on these positive results, OctoPlus said that it will proceed with preparations for further development of OP-145 and continue to find commercial partners. In November 2006, OctoPlus granted Green Cross Corporation, a pharmaceutical company in the Republic of Korea, an exclusive license to develop and market OP-145 for the Korean market.
Joost Holthuis, CEO of OctoPlus, said: “We are very pleased to have obtained proof of efficacy for OP-145. This further builds the product profile of OP-145 as a new approach in the treatment of infections and puts us in an excellent position to secure a global commercial partner for this product.”