Pharma Equity Group's subsidiary, Reponex Pharmaceuticals A/S, receives regulatory approval to initiate pivotal clinical trial with RNX-011 for life-threatening peritonitis

 Pharma Equity Group's subsidiary, Reponex Pharmaceuticals A/S, receives regulatory approval to initiate pivotal clinical trial with RNX-011 for life-threatening peritonitis Copenhagen, September 01, 2025Company Announcement No. 10Reponex Pharmaceuticals A/S (Reponex), a subsidiary of Pharma Equity Group A/S (NASDAQ: PEG), today announced that it has received regulatory approval to initiate a pivotal Phase 2 clinical trial with its drug candidate RNX-011. The study will investigate...

Hørsholm, 01/09/2025 (informazione.news - comunicati stampa - servizi)

Copenhagen, September 01, 2025

Company Announcement No. 10

Reponex Pharmaceuticals A/S (Reponex), a subsidiary of Pharma Equity Group A/S (NASDAQ: PEG), today announced that it has received regulatory approval to initiate a pivotal Phase 2 clinical trial with its drug candidate RNX-011. The study will investigate the treatment of secondary peritonitis, a serious and life-threatening intra-abdominal infection with high mortality.

The approval is a fundamental milestone for the company and a validation of the scientific strategy for RNX-011. The study addresses a critical unmet medical need in emergency abdominal surgery, where patient outcomes remain poor and where effective, local therapies to prevent serious complications are currently lacking.

The study is a randomized, placebo-controlled trial investigating a unique, triple-action combination therapy (fosfomycin, metronidazole, and GM-CSF) administered directly into the abdominal cavity during surgery.

The purpose of the study is to document that RNX-011 can , such as abscesses and the need for re-operation, which is the primary value-driving endpoint 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.

The study is expected to enroll 32 patients, with the first patient expected to be included in Q4 2025.

"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.

For further information, please contact:

Christian Tange, CEO, Pharma Equity Group A/S, phone: +45 29488417

Christian Vinding Thomsen, Chairman of the Board, Pharma Equity Group A/S, phone: +45 2622 7222

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