First patients enter Peptonic Medical AB’s clinical phase 2b study
Stockholm 3rd May 2016. - Peptonic Medical AB (publ) -– a company developing pharmaceuticals based on oxytocin – today announced that the first patients have been randomised in to its phase 2b clinical study. The aim of the study is to investigate the effect of Peptonic Medical’s product candidate Vagitocin® on vaginal atrophy in menopausal and post-menopausal women.
The Phase 2b study is a double-blind, placebo-controlled, multicenter study and comprise two arms of 80 patients each, in total 160 patients, in the main study. The objective of the study is to investigate the effect of Vagitocin® (oxytocin 400 IU/day) compared to placebo for the treatment of vaginal atrophy.
“We are pleased that we are moving ahead according to the time table, thus confirming that procedures and logistics are working as expected – from manufacturing of the clinical material to initiation of the clinical sites”, said Johan Inborr, CEO of Peptonic Medical. “All clinical sites are currently screening patients and the in-flow of candidates seems good – just like in previous studies”.
Three clinical centres in Sweden are participating in the clinical study. Associate professor Aino Fianu Jonasson, at the Department of obstetrics and gynecology at the Karolinska University hospital in Huddinge, will be the principal investigator of this clinical study.
Initial results from the study are expected by the end of this year.
For more information, please contact;
Johan Inborr, CEO
Telephone: +46 708 853 893
E-mail: johan.inborr@peptonicmedical.se
About Peptonic Medical AB
Peptonic Medical AB (publ) is an innovative Swedish pharmaceutical company developing oxytocin based products e.g. for the treatment of menopausal symptoms, such as vaginal atrophy. Peptonic Medical’s mission is to develop safe and effective drugs based on the well-known beneficial properties of oxytocin.
About the Phase 2b clinical study
The Phase 2b study is a double-blind, placebo-controlled, multicenter study and comprise two arms of 80 patients each, in total 160 patients. The objective of the study is to investigate the effect of Vagitocin® (oxytocin 400 IU/day) compared to placebo for the treatment of vaginal atrophy. The Vagitocin® gel will be stored in glass syringes and refrigerated during the study. In an exploratory part of the study, comprising 40 study subjects, the Vagitocin® gel will be stored in a laminate tube and refrigerated.
Three clinical centres in Sweden are participating in the clinical study. Associate professor Aino Fianu Jonasson, at the Department of obstetrics and gynecology at the Karolinska University hospital in Huddinge, will be the principal investigator of this clinical study. Initial results from the study are expected by the end of this year.