Pipeline

Clinical Phases of Reponex’s Treatments

 

Product Clinical Phase I Clinical Phase II Clinical Phase III Approval
RNX-011
Bacterial peritonitis
RNX-021, RNX-022, RNX-023
Chronic skin ulcers
RNX-041
Inflammatory bowel disease
RNX-051
Colorectal cancer

 

 

Reponex treatments

 

Bacterial Peritonitis (RNX-011)

Patients with perforated appendicitis, or other bowel perforations, may develop bacterial peritonitis, which is a bacterial infection in the lining of the abdomen. Untreated peritonitis can cause long-term damage to internal organs, prolonged hospitalisation and may even be fatal.

Reponex has developed an intraperitoneal treatment of bacterial peritonitis RNX-011. The aim of RNX-011 is to improve the treatment of peritonitis to reduce hospitalisation time, improved patient outcome and cost savings for health services.

Reponex has completed both a exploratory Phase II acceptability and safety study in uncomplicated appendicitis patients, and a Proof-of-concept Phase II clinical trial on patients with complicated perforated appendicitis. Both studies were completed at Herlev University Hospital, Denmark. In both studies RNX-011 was applied to the peritoneum during a laparoscopic intervention. In the preliminary phase II trial, all patients were allowed to be discharged within 23 hours on follow-up oral antibiotic, versus within 169 hours on intravenous antibiotics using the standard treatment. Read more about bacterial periotonitis.

 

Chronic Skin Ulcers (RNX-021, RNX-022 and RNX-023)

Reponex has formulated two gels for topical application to accelerate the healing of chronic skin wounds and ulcers, one with a single active substance (RNX-021) and another with the addition of two other wound healing agents (RNX-022).

Reponex has formulated a drug (RNX-023) in the form of a dusting powder that combines an active substance with an antibiotic for use on severely infected chronic wounds.

A randomized placebo controlled clinical phase II trial on RNX-021 is currently active but not recruiting, and is performed in collaboration with Bispebjerg Hospital. Subsequent trials and development on the two other products will be conducted. Read more about chronic skin ulcers.

 

 

Inflammatory Bowel Disease (RNX-041)

Pouchitis

A special group of previously operated ulcerative colitis patients, having complete colon resection, suffer from a chronic, Crohn’s-like inflammation of the pouch constructed from the terminal ileum to allow normal defecation. This inflammatory condition is called “pouchitis”. Pouchitis causes great pain, very frequent toilet visits and often significantly reduced quality of life for the patients. 

An exploratory clinical phase II trial on RNX-041 for the treatment of pouchitis is ongoing at Zealand University Hospital. The study will provide invaluable data for the design and execution of the subsequent placebo-controlled trial of RNX-041 for Crohn’s Disease.

Crohn’s disease

Crohn’s disease is an immune-mediated disease in which parts of the digestive tract come under destructive attack. Symptoms often include abdominal pain, diarrhoea, fever, abdominal distension, and weight loss. Crohn’s is a debilitating disease with a severe impact on patients’ quality of life. Recurring intestinal ulceration, narrowing and fistula formation are frequent manifestations. Reponex has developed a novel drug formulation containing three API’s (RNX-041), which is an improvement over the moderate results achieved by current intravenous treatment options. Administration of RNX-041 will be by endoscopic intra-intestinal delivery.

The aim of RNX-041 is to improve the treatment of Crohns and pouchitis to alleviate suffering and reduce the relapse rate in patients with this serious disease. Read more about Crohn’s disease and pouchitis.

 

 

Colorectal Cancer (RNX-051)

It has recently been discovered that generation, growth and spread of colorectal cancer tumors are promoted by certain bacteria in the large intestine, including fusobacteria, toxin-producing enterococci, coliforms and Bacteroides spp. These may exist in biofilm which invades the surface mucous layer of the colon and some can also infect the tumors, promoting growth and resistance to radio-and chemotherapy.

Reponex has designed a pharmaceutical composition for an innovative method of eradicating or reducing these cancer-promoting bacteria in the colon and eliminate the bacterial biofilm, by the intraintestinal administration of RNX-051. An exploratory clinical phase II trial on RNX-051 is ongoing at Zealand University Hospital.

The aim of RNX-051 is to significantly improve the health-care providers’ management of CRC to the benefit of patient by improving treatment outcome. Read more about colorectal cancer.