Last subject has completed treatment in the first part of Peptonic Medical’s phase 2b VVA study
Stockholm, 1st February 2017. Peptonic Medical AB (publ) - a company developing pharmaceuticals based on oxytocin - today announced that all of the randomized subjects of the first part of the ongoing phase 2b study (main study) now have completed the treatment and exited the study. In this study, the effect of treating menopausal and post-menopausal women suffering from vulvar and vaginal atrophy (VVA) with Peptonic Medcial’s oxytocin gel (Vagitocin®) is being investigated. A glass syringe has been used for storage and administration of the gel.
In total, 161 randomized subjects participated in the study. Of these, more than 97 per cent of the subjects have completed the 12-week treatment and attended all of the follow-up visits during the course of the study. This is a very satisfactory outcome and provides a good basis for assessing the effects of the treatment with oxytocin. With the exception of a slower than planned patient recruitment, the study has progressed well and in accordance with the plan and there are no major deviations or treatment related serious adverse effects to report.
The information collected during the study will now be analysed according to the study protocol and initial results are expected before end of March.
“I want to extend my gratitude to all those that have been engaged and contributed to the success so far – not least all the study subjects”, says Johan Inborr, CEO of Peptonic Medical, “It’s going to be exciting to see the results of this study.”.
For more information, please contact;
Johan Inborr, CEO
Telephone: +46 708 853 893
This information is information that Peptonic Medical 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, 2nd February 2017.
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 is stored in glass syringes and refrigerated during the study. In an exploratory part of the study, comprising 40 study subjects, the Vagitocin® gel is 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 gynaecology at the Karolinska University hospital in Huddinge, is the principal investigator of this clinical study.
Oxytocin is a peptide hormone that is produced within the neurons of the brain and released in to the blood stream. It is well known for its key role in labour and breast feeding, stimulating the contraction of the uterus and promoting milk ejection. Oxytocin has been used clinically since the 1960s as an IV drip and is also administered as an injection after childbirth to reduce uterine bleeding. More recently, oxytocin has been found to possess additional medicinal benefits as an anti-inflammatory agent, in promoting the healing of tissues as well as the possible reduction in certain types of pain.
Oxytocin is the active substance of Vagitocin®, which is currently being investigated for the treatment of vaginal atrophy in menopausal women. In this application, the oxytocin gel is administered vaginally.
About Peptonic Medical AB
Peptonic Medical AB (publ) is an innovative Swedish pharmaceutical company developing oxytocin based products including 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.