Reponex Pharmaceuticals receives approval for RNX-011 in life-threatening peritonitis trial.

Pharma Equity Group's subsidiary, Reponex Pharmaceuticals A/S, has received regulatory approval to initiate a pivotal clinical trial with RNX-011 for secondary peritonitis, a life-threatening intra-abdominal infection. The trial aims to investigate the drug's treatment efficacy and validate the company's scientific approach. This milestone is a significant step forward for Reponex and a validation of its research efforts.

Pharma Equity Group's subsidiary, Reponex Pharmaceuticals A/S, 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. The trial, which aims to investigate the drug's efficacy and validate the company's scientific approach, marks a significant milestone for Reponex and a validation of its research efforts.

The clinical trial, designed to demonstrate commercial value, is a randomized, placebo-controlled study that will investigate a unique triple-action combination therapy (fosfomycin, metronidazole, and GM-CSF) administered directly into the abdominal cavity during surgery. The primary goal is to document that RNX-011 can reduce the number of serious postoperative complications, such as abscesses and the need for re-operation, which is the primary value-driving endpoint for potential partners and payers. The study will also 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.

The trial is expected to enroll 32 patients, with the first patient expected to be included in Q4 2025. This regulatory approval is a crucial commercial milestone for Pharma Equity Group, as it moves from a strong proof-of-concept to a pivotal study designed to deliver the data that major pharmaceutical companies demand. The company's 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 the company's position in the upcoming partner dialogues.

Pharma Equity Group, a listed company on the Nasdaq Copenhagen stock exchange, is fully dedicated to advancing the medical projects of its subsidiary, Reponex Pharmaceuticals A/S. With an unwavering focus on healthcare, Pharma Equity Group's primary objective is to bring significant value to Reponex Pharmaceuticals' medical projects. The company is committed to providing extensive support, resources, and expertise to drive the development and success of these projects.

References:
[1] https://www.globenewswire.com/news-release/2025/09/02/3142362/0/da/Korrektion-Pharma-Equity-Groups-datterselskab-Reponex-Pharmaceuticals-A-S-har-f%C3%A5et-myndighedsgodkendelse-til-at-igangs%C3%A6tte-afg%C3%B8rende-klinisk-studie-med-RNX-011-til-livstruende-peri.html
[2] https://finance.yahoo.com/news/pharma-equity-groups-subsidiary-reponex-110600948.html
[3] https://www.tradingview.com/news/reuters.com,2025-09-01:newsml_MFN1BwHh6:0-analyst-group-analyst-group-comment-on-pharma-equity-group-s-regulatory-approval-to-initiate-phase-ii-clinical-trial-for-rnx-011/