Peptonic Medical receives approval for its clinical Phase 2b study

Stockholm 24th March 2016. - Peptonic Medical AB (publ) (“the Company” or “Peptonic”) – a company developing pharmaceuticals based on oxytocin – today announced that it has received approval from the Swedish Medical Products Agency to start the planned Phase 2b study. Previously Peptonic has received approval from the Ethical Vetting Board.

“Albeit expected, we are very pleased with having received these approvals. This means that we are on track according to the time table and that the first patients are expected to enter the study in May. ”, says Johan Inborr, CEO of Peptonic.

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® (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.

Results from the study are expected by the end of 2016.