Paion O.N (DE:PA8G) announced positive top-line results from the confirmatory Phase III trial of remimazolam for procedural sedation in bronchoscopy, adding to the positive results of a Phase III colonoscopy trial. It is currently conducting additional Phase I studies to further assess abuse potential as the final step of its US clinical development program. Paion is on track to file for approval in both the US (in procedural sedation via partner Cosmo Pharmaceuticals) and Japan (for general anaesthesia) by mid-2018. With the successful completion of the Phase III program for procedural sedation we increase our valuation to €240m (vs €214m) or €4.13 per share.
Positive top-line bronchoscopy data
The primary endpoint of successful completion of the bronchoscopy procedure without the need for rescue medication or more than five top-up doses was easily met: procedural success was 82.5% for remimazolam vs 3.4% for placebo (p<0.0001). Adverse events occurred less frequently with remimazolam compared to midazolam. The results in the secondary endpoints were in keeping with the Phase III colonoscopy study and the high-risk colonoscopy safety study, with induction and recovery from sedation faster with remimazolam than midazolam or placebo.
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