Panion Animal Health AB develops a new gene therapy treatment for epilepsy in dogs. The clinical phase of a safety study in dogs under the lead of associate professor David Woldbye at the University of Copenhagen was recently finalized, as reported on August 30, 2018.
More study results are now available from the blood samples of the dogs, specifically relating to the presence of the vector in the time after treatment. The testing was performed in a professional GLP testing facility in Germany with very high quality and using updated, sensitive methods.
“The results confirm our expectations and the sampling period was in the right time frame” says Anja Holm, CEO of Panion. “We find that this part of the study is successful and of good quality. It is also an important and reassuring result, that there was no spread of vector between the dogs, i.e. from treated to control dogs in contact, at the levels tested in this study model. This builds part of the picture for a new gene therapy treatment and we will discuss the results with the authorities. It is necessary to get a good indication of the overall registration requirements in the light of our data, before we can finalize the development plan for our intended new product.”
Panion Animal Health AB will meet with the US authorities in the FDA Presubmission meeting in October 2018. More information will be released about additional study results as the analyses will be finalized and reported in the coming months.