Peptonic Medical’s phase 2b study

Stockholm 2nd October, 2015. – The Board of Peptonic Medical (publ)  - a company developing pharmaceuticals based on oxytocin – today announced that it has completed the investigations in to the unexpected results of the clinical phase 2b study.

The investigation found that the most probable cause of this unsatisfactory result was that the aluminium tube used to deliver the daily oxytocin dose, reacted with the oxytocin gel to cause a reduction in viscosity, especially when the product was stored at room temperature. This in turn resulted in less adherence of the oxytocin gel to the vaginal mucosal epithelium and therefore an inadequate daily dose of the active compound was delivered to the tissue. In earlier studies a glass container was used without a notable decrease in viscosity.

Clinical observation and patient reports of leakage of the gel prompted storage of the tubes in refrigerator temperature instead of room temperature to preserve gel viscosity for the last 76 of 224 patients in the trial. Analysis of this sub-group, after the trial results were known, showed a significant reduction of the most bothersome symptom (one of three primary endpoints) compared with placebo further supporting the notion that decreased gel viscosity was the reason for the unexpected outcome of this study.

The Board, the management of the company and the lead clinician strongly believe that by changing containers, which can be done quickly and easily, in a repeat clinical study will show the effectiveness of oxytocin in treating vaginal atrophy in postmenopausal women. An alternative tube has been tested and shown to resolve the viscosity issue.

Discussions with both existing and new investors are underway to secure funding for a new study to be conducted during 2016. An information meeting for the shareholders has been scheduled for the 14th of October at 5pm in Stockholm. More information regarding the venue will be issued in the near future.

For more information, please contact;
Johan Inborr, CEO
Telephone:  +46 708 853 893

E-mail: johan.inborr@peptonicmedical.se