Peptonic Medical’s vaginal gel shows an excellent safety profile and reduces symptoms associated with urinary incontinence
Stockholm, May 29th, 2017. Peptonic Medical AB (publ) today announces additional results of the completed phase 2b study that show that the vaginal gel – without oxytocin – is well tolerated and its use doesn’t cause any serious adverse events (SAE). During the course of the study (including the main study and the exploratory part), only one SAE was reported among the total of 90 study subjects. This SAE, however, was deemed as ‘not related’ (to the treatment) as it concerned a study subject falling from a horse back. One reported AE was deemed as ‘probably related’ to the treatment. In this case, the study subject reported a good treatment effect and the AE was ‘mild’. All other cases of the reported were either ‘not related’ or only ‘possibly related’.
- These results are well in line with those from previous clinical studies with the vaginal gel and shows that it causes adverse events in only a few study subjects, says Johan Inborr, CEO of Peptonic Medical. The majority of the AE’s were mild and transient.
In addition to reporting on the ‘most bothersome symptoms’, women participating in the study were asked to respond to six statements regarding urinary and incontinence. Among those women that were treated with the placebo gel there was a statistically significant (p< 0.05) improvement in relation to five of the six statements.
Also for the sixth statement an improvement was reported by the study subjects, However, the improvement did not quite reach statistical significance (p=0.08).
- Urinary incontinence as well as vaginal atrophy are linked to the reduced production of estrogen at menopause. It was an unexpected, yet an exciting, finding that those patients that were treated with the placebo gel reported less incontinence symptoms, says Johan Inborr, CEO of Peptonic Medical. This offers additional competitive advantage to our vaginal gel once it is on the market. Urinary incontinence is a huge problem among the target patient group, but it seems that very few want to talk about it.
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®.
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 were approved by 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 .
For more information, please contact:
Johan Inborr, CEO
Mobil: +46 708 853 893
E-post: 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 29th May 2017.
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