Reponex gets approval to start pivotal trial for RNX-011 in life-threatening peritonitis.

Reponex Pharmaceuticals A/S, a subsidiary of Pharma Equity Group, has received regulatory approval to initiate a pivotal Phase 2 clinical trial with RNX-011 for treating secondary peritonitis, a life-threatening intra-abdominal infection with high mortality. The study aims to demonstrate commercial value for the drug candidate and addresses a critical unmet medical need in emergency abdominal surgery. The trial will investigate the treatment of secondary peritonitis, a serious and life-threatening intra-abdominal infection with high mortality.

Copenhagen, September 01, 2025 - Pharma Equity Group's subsidiary, Reponex Pharmaceuticals A/S (Reponex), has received regulatory approval to initiate a pivotal Phase 2 clinical trial with its drug candidate RNX-011 for the treatment of secondary peritonitis, a life-threatening intra-abdominal infection with high mortality [1]. This approval marks a significant milestone for the company and validates the scientific strategy behind RNX-011.

The trial, designed to demonstrate commercial value, will investigate a unique, triple-action combination therapy (fosfomycin, metronidazole, and GM-CSF) administered directly into the abdominal cavity during surgery. The primary objective is to reduce the number of serious postoperative complications, such as abscesses and the need for re-operation, which are critical value-driving endpoints for potential partners and payers. Additionally, the study will measure the treatment's effect on local inflammation (IL-6) and patients' overall recovery (QoR-15) to support the clinical effect with strong mechanistic data [2].

The study is expected to enroll 32 patients, with the first patient expected to be included in Q4 2025. The regulatory approval of this pivotal study is a crucial commercial milestone for Pharma Equity Group, as it transitions from a strong proof-of-concept to a pivotal study designed to deliver the data that major pharmaceutical companies demand. The company aims to prove that RNX-011 can prevent life-threatening complications and fundamentally improve the treatment for a very vulnerable patient group [1].

"The regulatory approval of our RNX-011 study is a crucial commercial milestone for Pharma Equity Group. We are now taking the step from a strong proof-of-concept to a pivotal study designed to deliver the data that major pharmaceutical companies demand. Our goal is clear: to prove that RNX-011 can prevent life-threatening complications and fundamentally improve the treatment for a very vulnerable patient group. This approval significantly strengthens our position in the upcoming partner dialogues," says Christian Tange, CEO of Pharma Equity Group A/S.

Pharma Equity Group, a listed company on the Nasdaq Copenhagen stock exchange, is fully dedicated to advancing the medical projects of Reponex Pharmaceuticals A/S. The company's primary objective is to bring significant value to Reponex Pharmaceuticals' medical projects and is committed to providing extensive support, resources, and expertise to drive their development and success [2].

References:
[1] https://www.globenewswire.com/news-release/2025/09/01/3142115/0/en/Pharma-Equity-Group-s-subsidiary-Reponex-Pharmaceuticals-A-S-receives-regulatory-approval-to-initiate-pivotal-clinical-trial-with-RNX-011-for-life-threatening-peritonitis.html
[2] https://www.nasdaq.com/press-release/pharma-equity-groups-subsidiary-reponex-pharmaceuticals-s-receives-regulatory