Last study subject enters the exploratory part of Peptonic Medical’s phase 2b study
Stockholm, January 13, 2017 – Peptonic Medical AB (publ) (“Peptonic” or “the Company”) – a company developing pharmaceuticals based on oxytocin – today announced that the last study subject of the Company’s phase 2b clinical study has been enrolled and started the treatment. This concerns the second (exploratory) part of the clinical phase 2b study, in which the oxytocin gel is stored in laminated tubes and administered using disposable applicators. In total, forty study subjects are participating in this part of the study.
”I want to thank the personnel of the clinical sites for their excellent patient recruitment work”, says Johan Inborr, CEO of Peptonic,”Summer vacations and public holidays have delayed the recruitment, despite the magnificent efforts by the clinics, but now all patients have been enrolled, and we can look forward to the results of the study”.
Enrolment to the main study (glass syringes used for gel storage and administration) was completed in November 2016 and the last study subjects will complete the treatment and exit this study in the near future. Initial results of the main study are expected during the first quarter this year, whereas the results of the explorative study are expected in the second quarter.
For more information, please contact:
Johan Inborr, CEO
Phone: +46 708 853 893
E-mail: johan.inborr@peptonicmedical.se
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 13th January 2017.
About Peptonic Medical AB (publ)
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. Oxytocin has a long history of safe medical use and offers an alternative to estrogen and estrogen-like acting compounds for menopausal and postmenopausal women. Peptonic Medical AB (publ)’s mission is to develop safe and effective drugs based on 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 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 laminated 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.
About oxytocin
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 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.