Pharma Equity Group’s subsidiary, Reponex Pharmaceuticals A/S, reports highly positive final results from the phase-2 clinical trial of the company’s patented drug candidate RNX-051.

5 April 2024

Company Announcement No. 11

Pharma Equity Group’s subsidiary, Reponex Pharmaceuticals A/S, reports highly positive final results from the phase-2 clinical trial of the company’s patented drug candidate RNX-051.

Reponex Pharmaceuticals A/S (Reponex) today announced positive final results from the phase-2 clinical proof-of-concept trial of the drug candidate RNX-051, the MEFO trial, based on received high level summary from the Company’s clinical site.

Reponex’s MEFO-trial
This concerns the treatment of patients with right-sided colon cancer and right-sided colon polyps/adenomas (precursors of cancer) with the Company’s drug candidate RNX-051. The company’s clinical collaborators who have performed the trial report the following:

Background
Patients with precursor lesions to cancer in the colon (adenomas) harbor a different gut microbiota than healthy controls. Distinct bacteria have been found to influence the bowel lining by promoting chronic inflammation and through interaction with molecular mechanisms in the bowel cells that may lead to bowel cancer. A central mechanism of the bacteria with cancer promoting abilities is to produce a biofilm lining the inner surface of the bowel wall.

In patients where the cancer has already developed, it is known that distinct bacteria such as Fusobacterium nucleatum and Bacteroides fragilis shift the immune system within the tumor leading to a greater risk of metastatic spread of the cancer. The mechanisms are complex but mediated through reducing the function of immune cells that are actively killing cancer cells.

Rationale
Administering the two antibiotics fosfomycin and metronidazole (constituents of RNX-051) with distinct properties ensuring an effect both on the colon lining and inside the cancer through local administration may change the milieu leading to a reduced risk of adenoma generation and improved sensitivity to immune cells or therapies that modulate the immune system, such as immune check-point inhibitors. The MEFO trial consisted of two arms: the first in patients with adenomas (the “adenoma arm”) and second in patients with cancers in the right side of the bowel (the “cancer arm”). A major aim was to change the biofilm in the “adenoma arm” and improve the tumor-related bacterial composition in the “cancer arm”. In both arms there was a focus on the modulation of the immune cells in a positive way to increase their ability to kill precursor or cancer cells.