The aim of this project is to improve the treatment of incipient or established peritonitis (inflammation of the lining of the abdominal cavity) as a consequence of appendicitis or other intestinal perforations, thereby significantly improving survival and reducing morbidity and the duration of hospitalization. Following a successful preliminary acceptability and safety study, an explorative clinical trial in patients with ruptured appendix has also been successfully completed.
Our clinical proces
RNX-011 is a combination of 3 active pharmaceutical ingredients (API). In a preliminary clinical proof of concept study in patients with perforated appendicitis undergoing laparascopic appendicectomy, the addition of RNX-011 to standard of care (SOC) was associated with a shorter hospital stay (13 hours in the RNX-011 group versus 84 hours in the SOC group) and a trend to quicker return to normal activities (6 days in the RNX-011 group versus 10 days in the SOC group (1). In addition, there were no complications in the patients receiving RNX-011, whereas two cases of intra-abdominal abscess (localised infection in the abdominal cavity) occurred among patients receiving standard of care.
Rationale for developing treatment for bacterial peritonitis
Peritonitis is an inflammation of the peritoneum, the epithelium that lines the abdominal cavity. The inflammation can occur either locally or diffusely in the abdomen. The severity of the disease is closely related to the extent of the inflammation. A local inflammation (as seen in uncomplicated appendicitis) is a less severe disease than diffuse peritonitis (e.g., secondary to a perforation of the colon with faecal contamination throughout the abdomen). In the latter case, peritonitis can have long-term adverse consequences for the patient even with the best current treatment options. Current practice for both local and diffuse peritonitis is surgical intervention and with intravenous (systemic) administration of antibiotics.
RNX-011 is a new combination and new route of administration of drugs to treat peritonitis as an add on to current standard surgical intervention. RNX-011 is administered intraperitoneally, i.e, directly into the abdominal cavity, thereby achieving the highest drug concentrations at the site of infection.