Recce Pharmaceuticals (ASX:RCE) said the Human Research Ethics Committee (HREC) approved a protocol amendment to its phase two clinical trial of Recce 327 topical gel treatment candidate for diabetic foot infections, advancing the study to a pivotal phase three clinical trial, according to a Monday Australian bourse filing.

A pivotal phase three trial is considered a registrational study designed to generate the safety and efficacy data required to support regulatory approval applications. The trial has treated 18 of a potential 200 total patients and full enrollment is expected by the end of 2027.

The protocol amendment expands eligibility to include moderate infection patients in addition to mild infection patients.

The company said its completed phase two trial achieved a 93% primary efficacy endpoint at day 14 and 86% clinical response by day seven.

Recce Pharmaceuticals' shares rose 1% in recent trading on Monday.