Press release 2017-04-11
Xbrane Biopharma has, in preparation for upcoming clinical trials, done a comparative study in minipigs on the 1 month formulation of Spherotide. The study involved two groups of ten minipigs in total, receiving one injection of Spherotide and the originator product, respectively. The primary objective of the study was to compare the testosterone suppression in the subjects 1 month after injection which, after scientific advice with regulatory authorities, will be the primary endpoint in the pivotal phase III clinical study for Spherotide. The secondary objective of the study was to compare the pharmacokinetic profiles, even though this will not be the primary endpoint of the upcoming clinical trial.
Spherotide demonstrated no significant difference vs. the originator product on the clinically relevant endpoint, testosterone suppression 1 month after injection. Further, Spherotide demonstrated no significant difference in the safety profile vs. the originator product. The pharmacokinetic profile of Spherotide demonstrated a higher concentration maximum (Cmax) and higher total drug exposure (AUCinf) compared to the originator product. The study was performed by CiToxLAB in Denmark under GLP (Good Laboratory Practice).
"The primary endpoint in the upcoming clinical study will be related to testosterone suppression during the end of the treatment period for one injection. Seeing no significant difference between Spherotide and the originator product on that endpoint in this in-vivo trial in a larger animal gives us further confidence in Spherotide ahead of the clinical trials", says Martin Åmark, Xbranes CEO.
Spherotide is a generic long acting formulation with the active substance triptorelin (originator product Decapeptyl®/Pamorelin®/Trelstar®) and is used primarily in the treatment of prostate cancer, endometriosis and uterine fibroids. The drug is based on encapsulation of the active ingredient in biodegradable microspheres that degrade in the body after injection and create a long acting effect.
About Xbrane Xbrane is a commercial phase Swedish biopharmaceutical company specialized in biosimilars and long acting injectables. Xbrane has world leading expertise in developing generics for long acting injectable drugs and proprietary high-yield protein expression technology for the development of biosimilars. Xbranes's headquarter is located in Stockholm and the company's in-house research and development facilities are in Sweden and Italy. Xbrane is listed at Nasdaq First North since February 3 rd , 2016 under the name XBRANE and Avanza Bank AB is Xbrane's certified advisor. For more information see www.xbrane.com .
For further information, please contact: Martin Åmark Chief Executive Officer M: +46 (0) 763-093 777 E: martin.amark@xbrane.com
This information is information that Xbrane Biopharma AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:00 April 11 2017.
Attachments:
