On February 18, 2019 Xspray Pharma AB reported the results of a clinical Phase I pilot study with its HyNap-Sora drug candidate (Press release, Xspray, FEB 18, 2019, View Source [SID1234649548]). The study examined HyNap-Sora’s bioavailability compared to the sorafenib cancer drug, currently marketed as Nexavar for the treatment of unresectable hepatocellular carcinoma and advanced renal cell carcinoma. Both investigated HyNap compositions demonstrated significantly increased bioavailability. The variability between subjects in AUC and Cmax was reduced to half compared to Nexavar for one of the HyNap-Sora formulations.
In the completed Phase I clinical trial in 14 healthy subjects, bioavailability of two different formulations of HyNap-Sora was assessed in comparison with Nexavar. The results are positive and the study achieved its primary purpose to show increased bioavailability compared to the originator product. In addition, and as shown in earlier studies with Xspray’s lead product candidate, HyNap-Dasa, the study also showed reduced between subject variability.
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"Sorafenib has a very different pharmacokinetic profile than our product candidates based on nilotinib and dasatinib. Therefore, I’m very pleased that we achieved the primary purpose of this study with sorafenib which enables continuation of the development program. It confirms and strengthens our belief that HyNap formulations of PKIs have the potential to improve both present and upcoming products with poor solubility, improving efficacy and safety enhancing patients’ quality of life during this type of therapy," says Per Andersson, CEO of Xspray.
The clinical results in summary:
• The HyNap formulations were administered at half the dose compared to Nexavar to account for expected increase in bioavailability
• Area under the curve (AUC) was approximately 80 % for the HyNap-Sora formulations compared to Nexavar, indicating that the bioavailability of Sorafenib from HyNap-Sora was 1.6-fold higher
• The maximum concentration of Sorafenib in plasma (Cmax) was approximately 95 % compared to Nexavar.
• The variability between subjects in AUC and Cmax was reduced to half compared to Nexavar for one of the HyNap-Sora formulations.
Sorafenib is a compound with low aqueous solubility and low bioavailability from the sorafenib tablet (Nexavar). The present study demonstrates that the HyNap technology can increase the extent of absorption of sorafenib and reduce between subject variability by improving the solubility.