Peptonic announces results of the exploratory part of its phase 2b study – provide further support for the launch of a non-prescription product
Stockholm, May 17th, 2017. Peptonic Medical AB (publ) today announces that the results of the exploratory part of its clinical phase 2b study show comparable treatment effects to the first part (main study). In short, this means that no significant differences were found between placebo and oxytocin for any of the defined clinical endpoints, whereas the placebo gel gave a strong effect on the Most Bothersome Symptom (MBS). All study subjects of the placebo arm (10 out of 10) reported symptom relief and half of them were symptom free at the end of the treatment period.
The objective of this study was to show that using a laminate tub with a disposable applicator give the same results as the glass syringe of the main study. This to prove that the laminate tube is commercially viable, as indicated by the results of ongoing stability tests. This objective was met with good margins, which enforces the Company’s plans to launch the vaginal gel without oxytocin as a non-prescription treatment for vaginal atrophy.
In this study, a total of 41 study subjects were randomised – 10 of the placebo arm and 31 of the active (oxytocin) arm. Due to the low number of study subjects in this study, statistical significance values didn’t reach the same levels as in the main study, but the magnitude of the effects were on the same level.
– In this situation, these results feel like a great success. They show the same strong effect of the placebo gel as in the main study, which strengthens our conviction that this gel will be an attractive self-care product, says Johan Inborr, CEO of Peptonic Medical.
The Company has registered a new tradename - VagiVital® for the new product and preparations for filing a patent application are underway.
Initially, VagiVital® is planned to be launched in Sweden during 2018 and thereafter in the neighbouring Nordic countries. The Nordic market for products used to the treatment of vaginal atrophy is estimated to approximately SEK 700 million. This market is dominated by estrogen based non-prescription products. There is a growing awareness among women regarding the risks of long term use of estrogen. Hence, the need for effective and safe treatment options is growing. VagiVital® meets this need. Pharmacies will be the primary sales channel but other channels may be considered. Marketing and promotion will be supported by the documented efficacy from large clinical studies, which makes VagiVital® unique among its competing self-care products. In parallel with the CE-marking and manufacturing sale-up processes we will be looking for distributors and commercial partners both in the home market (Sweden/Nordics) and abroad. This to give us more alternatives to find the best and most cost-effective ways of launching VagiVital®.
– Clearly, bringing VagiVital® to the market is a change of direction of Peptonic. However, it is not a 180 degree turnaround. We are still a serious player in the field of women’s health, we are still focussing on vaginal atrophy, and our development work is still based on high quality clinical research, says Johan Inborr, CEO of Peptonic Medical.
The Company has announced its plan for a rights issue to raise funds to finance the preparations for the launch of VagiVital®. The proposed terms are subject to the approval of the AGM on May 18th. Fully subscribed, the rights issue will bring approximately 12 MSEK to the Company (before issue costs). For more information, please visit: www.peptonicmedical.se .
A thorough investigation of the results and all available information from the study is still underway. This with the aim of finding an explanation to the unexpected results and to come up with a plan for the continued development of Vagitocin®.
For more information, please contact:
Johan Inborr, CEO
Mobil: +46 708 853 893
E-post: johan.inborr@peptonicmedical.se
Denna information är sådan information som Peptonic Medical AB (publ) är skyldigt att offentliggöra enligt EU:s marknadsmissbruksförordning. Informationen lämnades, genom ovanstående kontaktpersons försorg, för offentliggörande den 17 maj 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. The laminated tube is a commercially more viable container than the glass syringe.
The primary clinical efficacy endpoint was to show a statistically significant decrease in the level of the MBS by the treatment with Vagitocin® (oxytocin) – both from baseline at the beginning of the treatment and vs. placebo during the course of the treatment period. At the start of the study, the women participating in the study have assessed the severity of the Most Bothersome Symptom on a scale from 0 (no symptoms) to 3 (severe symptoms). Only those with a score of 2 or 3 were included in the study. At the end of the treatment period, the women made a new assessment of the severity of the symptoms.
Three clinical centres in Sweden are participating in the clinical study. These were Karolinska Sjukhuset in Huddinge, Uppsala Akademiska Sjukhuset and Norrlands Universitetssjukhus in Umeå 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 Peptonic
Peptonic Medical AB (publ) is an innovative Swedish biopharma company developing products within the field of women’s health. The Company was founded in 2009 and its first candidate drug product is Vagitocin® – an estrogen-free product for the treatment of vaginal atrophy.
VagiVital® is a registered trademark of Peptonic Medical. The product is being developed for the non-prescription use for the treatment of vaginal atrophy.
Find out more at www.peptonicmedical.se