Highlights

  • Recce Pharmaceuticals received Human Research Ethics Committee approval to upgrade its Australian R327G trial from Phase 2 to pivotal Phase 3.
  • The trial will expand eligibility to include Mild and Moderate diabetic foot infections.
  • The Australian and Indonesian Phase 3 programs are targeting combined enrolment completion by the end of 2027.
  • Recce raised A$6.4 million in July 2026 to support clinical programs and commercial activities.

Recce Pharmaceuticals (ASX:RCE) has received approval to advance its Australian clinical trial of RECCE® 327 Topical Gel (R327G) from Phase 2 to a pivotal Phase 3 study for diabetic foot infections.

The Human Research Ethics Committee approval, announced on 22 June 2026, expands the trial design and aligns the Australian program with regulatory expectations for potential product registration.

The Phase 3 upgrade strengthens the development pathway for R327G, although clinical enrolment, trial outcomes and regulatory approval remain key steps before potential commercialisation.

What Was Announced?

The Human Research Ethics Committee (HREC) approved amendments to Recce's Australian R327G trial protocol.

The changes expand patient eligibility beyond Mild diabetic foot infections (DFI) to include Moderate cases, which the company estimates represent approximately 80% of DFI presentations.

The amended protocol also extends eligibility to infected ulcers located below the knee and allows analysis at the individual ulcer level rather than only assessing patient-level outcomes.

The Australian study has now been reclassified as a pivotal Phase 3 trial, designed to align with requirements of the Therapeutic Goods Administration (TGA) and U.S. Food and Drug Administration (FDA).

At the time of the announcement, 18 of the expected 200 Australian participants had been enrolled.

Recce is targeting completion of combined enrolment across Australian and Indonesian Phase 3 programs by the end of 2027, with an interim efficacy analysis planned after 50% enrolment.

Previous Phase 2 results reported by Recce showed a 93% primary efficacy endpoint at Day 14 and an 86% clinical response rate at Day 7, with no serious adverse events recorded.

Why This Matters

For Recce (ASX:RCE), moving R327G into a pivotal Phase 3 study represents an important regulatory development milestone for its lead anti-infective program.

Diabetic foot infections remain a significant medical challenge due to increasing antibiotic resistance and the risk of complications including hospitalisation and lower-limb amputation.

A topical treatment applied directly to infected ulcers could provide an alternative approach to systemic antibiotics if it demonstrates efficacy in larger controlled trials.

Expanding the trial to include Moderate infections may also broaden the potential patient population if R327G eventually receives approval.

However, the Phase 3 upgrade does not confirm clinical effectiveness. The outcome will depend on enrolment completion, trial results and regulatory review.

Company Background

Recce Pharmaceuticals (ASX:RCE) is a clinical-stage biotechnology company developing synthetic anti-infective compounds targeting drug-resistant bacteria.

Its lead compound, RECCE® 327, is being developed in multiple formulations, including R327G topical gel for diabetic foot infections and skin infections.

The injectable formulation of RECCE® 327 has previously been evaluated in early-stage studies targeting conditions including urinary tract infections, urosepsis and broader gram-negative bacterial infections.

The company has stated that RECCE® 327 has been included on the World Health Organization's list of antibacterial products in clinical development.

Recce is also pursuing commercialisation opportunities alongside clinical development activities.

Financial Position

Recce completed a share purchase plan in July 2026 that raised A$2.4 million, following an earlier institutional placement.

Combined proceeds from the funding round totalled A$6.4 million at an issue price of A$0.40 per share.

The company stated that the funds will support clinical trial activities, IND-enabling programs, the MENA commercial licensing process and general Working Capital requirements.

The Phase 3 announcement did not disclose an updated cash balance. Investors should refer to the company's latest financial disclosures for current cash position and quarterly expenditure levels.

What Comes Next?

The next key milestones for Recce (ASX:RCE) include progress toward the 200-patient Australian enrolment target and equivalent recruitment in the Indonesian Phase 3 program.

The company is targeting combined enrolment completion by the end of 2027, with interim efficacy analysis planned at the 50% enrolment point.

Investors will also monitor progress on the non-binding MENA licensing term sheet announced in May 2026, which covers multiple Middle Eastern and North African markets.

The proposed agreement includes potential signing and milestone payments of up to approximately US$3.5 million, along with royalties on net sales, subject to conversion into a binding agreement.

Risks

Recce (ASX:RCE) remains a clinical-stage, pre-revenue biotechnology company exposed to trial, funding and regulatory risks. Phase 3 outcomes may not replicate earlier Phase 2 findings, and slower enrolment could delay timelines. The company continues to rely on capital raising and other funding sources to support development. The MENA licensing arrangement remains non-binding, and regulatory approval for R327G is not guaranteed even if Clinical Trials produce positive results.

Investor Takeaway

The HREC approval allows Recce to advance its Australian R327G diabetic foot infection study into a pivotal Phase 3 trial, expanding the patient population and strengthening the regulatory development pathway.

The milestone reduces uncertainty around trial design and regulatory alignment but does not establish clinical success.

For Recce (ASX:RCE), upcoming focus areas include enrolment progress, interim trial analysis, funding management and whether commercial discussions such as the MENA licensing term sheet progress into binding agreements.