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Asset Brief

RECCE 327

RCE·Recce Pharmaceuticals·Bacterial infections and sepsis, including diabetic foot infections·Phase 3·[ TODO: fill in ]

Plain-language Brief

The trial in plain terms

The disease: Bacterial infections cover a wide spectrum of conditions, from localised wound infections to life-threatening bloodstream infections (sepsis). Diabetic foot infections (DFIs) are a clinically serious subset in which bacteria infect the soft tissue or bone of the foot in people with diabetes, frequently involving multiple bacterial species simultaneously. Sepsis occurs when the body's response to infection causes widespread organ stress, and it carries high mortality even with current antibiotic treatment. Antibiotic-resistant bacteria are a growing problem in both settings, limiting treatment options for clinicians.
What the asset is trying to do: RECCE 327 is described by the company as a synthetic anti-infective polymer, meaning it is a man-made, chain-like molecule rather than a naturally derived or semi-synthetic compound like most conventional antibiotics (per Recce Pharmaceuticals company disclosures). The company states it has a novel mechanism of action distinct from traditional antibiotics, though the precise molecular target has not been publicly disclosed. Because its mechanism is described as different from existing antibiotic classes, it may act against bacteria that have developed resistance to standard drugs, though no peer-reviewed comparative data have been cited in company announcements to date.
What the trial is measuring, and why it matters: The lead clinical program has received Human Research Ethics Committee (HREC) approval to advance a Phase 3 trial in diabetic foot infections, as disclosed in the company's 22 June 2026 ASX announcement. A positive regulatory inspection outcome for the Phase 3 trial was also reported on 21 April 2026 (per ASX announcement). Specific primary and secondary endpoints, enrolment targets, and trial registry identifiers have not been publicly disclosed in the materials provided.
Efficacy benchmarks in this setting: In the diabetic foot infection setting, approved systemic antibiotics such as daptomycin and linezolid have served as comparators in Phase 3 registrational trials; for example, the ESTABLISH trials of oritavancin in acute bacterial skin and skin structure infections (which overlap with DFI) reported clinical response rates of approximately 80% in the oritavancin arm (per Corey et al, New England Journal of Medicine, 2014). For sepsis, guidelines-based antibiotic therapy is associated with 28-day mortality rates that vary widely by pathogen and severity. Early-stage or preclinical figures for RECCE 327 are not statistically comparable to these approved-therapy benchmarks and should not be interpreted as equivalent.
Commercial context: Multiple antibiotics are currently approved for diabetic foot infections and systemic bacterial infections globally, including in Australia, the United States, and Europe. A Middle East licensing term sheet was signed and subsequently addended in May 2026 (per ASX announcements 26 May and 27 May 2026); financial terms of that term sheet have not been publicly disclosed. In June 2026, Recce Pharmaceuticals completed a placement and share purchase plan (SPP) to raise $8 million (per ASX announcement 26 June 2026). RECCE 327 is described across company materials as the company's lead asset across wound and systemic infection programs.

Sources for this brief (7)

HREC Approval Accelerates Global Phase 3 DFI Strategy · Recce Pharmaceuticals ASX Announcement · accessed 26 June 2026
Positive Regulatory Inspection Outcome for Phase 3 Trial · Recce Pharmaceuticals ASX Announcement · accessed 26 June 2026
Recce Signs Middle East Licensing Term Sheet · Recce Pharmaceuticals ASX Announcement · accessed 26 June 2026
Placement & SPP to raise $8 million · Recce Pharmaceuticals ASX Announcement · accessed 26 June 2026
Single-Dose Oritavancin in the Treatment of Acute Bacterial Skin Infections (SOLO I) · New England Journal of Medicine · accessed 26 June 2026
Infectious Diseases Society of America (IDSA) Clinical Practice Guidelines for Diabetic Foot Infections · Clinical Infectious Diseases · accessed 26 June 2026
ClinicalTrials.gov — search: RECCE 327 / diabetic foot infection

Trial Design

Design summary

Phase: Phase 3
Design type: [ TODO: fill in ] Phase 3 trial in diabetic foot infections; HREC approval received (per ASX announcement 22 June 2026).
Primary endpoint: [ TODO: fill in ]
Key secondary endpoints: [ TODO: fill in ]
Enrolment target: [ TODO: fill in ]
Current enrolment status: [ TODO: fill in ] HREC approval received June 2026; trial registry registration and enrolment commencement not yet publicly confirmed in available materials.
Sites: [ TODO: fill in ]
Expected readout window: [ TODO: fill in ]

Asset Track Record

Did RCE deliver against its own guidance?

Past catalysts on this ticker, reconciled against the announcement parse pipeline. Hover any row for the parsed outcome detail.

19 July 2026financingExtension to Share Purchase Plan Closing Datehitsrc ASX ↗
19 July 2026financingUpdate - Proposed issue of securities - RCEhitsrc ASX ↗
13 July 2026regulatory decisionRECCE® 327 (R327) and RECCE® 529 (R529) Intellectual Property Office of Vietnam (IP Viet Nam) — Vietnamese Patent Granted for RECCE Anti-Infectiveshit · positivesrc ASX ↗
5 July 2026financingShare Purchase Plan - Letter and Offer Booklethitsrc ASX ↗
30 June 2026financingFY2026 R&D Tax Incentive receiptoverduesrc ASX ↗
30 June 2026otherAUD $3.7M Income Tax Refund Receivedhitsrc ASX ↗
22 June 2026data readoutRECCE 327 Phase 3 DFI interim analysis (155 patients)hit · positivesrc ASX ↗
26 June 2026financingProposed issue of securities - RCEhitsrc ASX ↗

Class Catalyst Calendar

What's landed, what's next for RECCE 327 and peers

RECCE 327's own upcoming catalysts alongside class-defining historical readouts and upcoming primary completion dates in the same mechanism classes. Each event moves the broader thesis for RECCE 327. Showing past 6 months and next 12 months · 8 later hidden.

ConferenceAACR Annual Meeting 2026· ChicagoApr 2026
ConferenceASCO Annual Meeting 2026· ChicagoMay 2026
Today
ConferenceESMO Congress 2026

Trial design comparison

How RECCE 327 reads against active peer trials

Same axes, same units. Discontinued and historical pivotal trials excluded; see Competitor Landscape below for the full set.

Trial	Sponsor	Class	Phase / Line	Design	Primary endpoint	Dosing	Key eligibility	n
RECCE 327	Recce Pharmaceuticals	Synthetic polymer antibiotic	Phase 3[ TODO: fill in ]	[ TODO: fill in ] Phase 3 trial in diabetic foot infections; HREC approval received (per ASX announcement 22 June 2026).	[ TODO: fill in ]	[ TODO: fill in ]	[ TODO: fill in ]	0
An Oral Doxycycline Regimen to Prevent Bacteremia Following Dental Procedures

Competitor Landscape

Competing programmes by mechanism and phase

Read-across commentary attached per trial. Phase ordering preserved within each group.

OtherASX peers ›

25 activeexpand ›

UO
An Oral Doxycycline Regimen to Prevent Bacteremia Following Dental Procedures
Phase 4
University of Santiago de Compostela·Not yet recruiting·Primary completion 15 Jan 2025·NCT06422221
1 site
PI: Pedro Diz Dios

Curated Commentary

Third-party coverage(none curated yet)

expand ›

External analyst notes, journalism, and industry commentary cited with attribution.

No third-party coverage curated for RECCE 327 yet. Broker coverage of Recce Pharmaceuticals is thin; named analyst notes will appear here as they become available. For now, see the company's ASX announcements and the linked sponsor / class sources elsewhere on this page.

Asset Track Record

Did RCE deliver against its own guidance?

Past catalysts on this ticker, reconciled against the announcement parse pipeline. Hover any row for the parsed outcome detail.

19 July 2026financingExtension to Share Purchase Plan Closing Datehitsrc ASX ↗
19 July 2026financingUpdate - Proposed issue of securities - RCEhitsrc ASX ↗
13 July 2026regulatory decisionRECCE® 327 (R327) and RECCE® 529 (R529) Intellectual Property Office of Vietnam (IP Viet Nam) — Vietnamese Patent Granted for RECCE Anti-Infectiveshit · positivesrc ASX ↗
5 July 2026financingShare Purchase Plan - Letter and Offer Booklethitsrc ASX ↗
30 June 2026financingFY2026 R&D Tax Incentive receiptoverduesrc ASX ↗
30 June 2026otherAUD $3.7M Income Tax Refund Receivedhitsrc ASX ↗
22 June 2026data readoutRECCE 327 Phase 3 DFI interim analysis (155 patients)hit · positivesrc ASX ↗
26 June 2026financingProposed issue of securities - RCEhitsrc ASX ↗

Class Catalyst Calendar

What's landed, what's next for RECCE 327 and peers

ConferenceAACR Annual Meeting 2026· ChicagoApr 2026
ConferenceASCO Annual Meeting 2026· ChicagoMay 2026
Today
ConferenceESMO Congress 2026

Trial design comparison

How RECCE 327 reads against active peer trials

Same axes, same units. Discontinued and historical pivotal trials excluded; see Competitor Landscape below for the full set.

Trial	Sponsor	Class	Phase / Line	Design	Primary endpoint	Dosing	Key eligibility	n
RECCE 327	Recce Pharmaceuticals	Synthetic polymer antibiotic	Phase 3[ TODO: fill in ]	[ TODO: fill in ] Phase 3 trial in diabetic foot infections; HREC approval received (per ASX announcement 22 June 2026).	[ TODO: fill in ]	[ TODO: fill in ]	[ TODO: fill in ]	0
An Oral Doxycycline Regimen to Prevent Bacteremia Following Dental Procedures

Competitor Landscape

Competing programmes by mechanism and phase

Read-across commentary attached per trial. Phase ordering preserved within each group.

OtherASX peers ›

25 activeexpand ›

UO
An Oral Doxycycline Regimen to Prevent Bacteremia Following Dental Procedures
Phase 4
University of Santiago de Compostela·Not yet recruiting·Primary completion 15 Jan 2025·NCT06422221
1 site
PI: Pedro Diz Dios

RECCE 327n = 0

Recce Pharmaceuticals·Synthetic polymer antibiotic·Phase 3·[ TODO: fill in ]

Design: [ TODO: fill in ] Phase 3 trial in diabetic foot infections; HREC approval received (per ASX announcement 22 June 2026).
Primary endpoint: [ TODO: fill in ]
Dosing: [ TODO: fill in ]
Eligibility: [ TODO: fill in ]

An Oral Doxycycline Regimen to Prevent Bacteremia Following Dental Proceduresn = —

University of Santiago de Compostela·—·Phase 4

Design: —
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Efficacy and Safety of 7 Versus 14 Days of Antibiotic Treatment for Pseudomonas Aeruginosa Bacteraemian = —

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla·—·Phase 4

Design: —
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Improving Therapeutic Drug Monitoring and Dosing for Vancomycin in Young Infants With Infections (VANCAPP) (Part 2)n = —

Murdoch Childrens Research Institute·—·Phase 4

Design: —
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Therapeutic Options for CRABn = —

Clinical Hospital Centre Zagreb·—·Phase 4

Design: —
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PipEracillin Tazobactam Versus mERoPENem for Treatment of Bloodstream Infections Caused by Cephalosporin-resistant Enterobacteriaceae (PETERPEN)n = —

Rambam Health Care Campus·—·Phase 4

Design: —
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Beta-lactam Plus Levofloxacin to Enhance Therapy in Streptococcal Septicemian = —

Mahidol University·—·Phase 4

Design: —
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Dosing: —
Eligibility: —

Comparison of Cloxacillin and Benzylpenicillin in Penicillin Susceptible S. Aureus Bacteraemian = —

Region Skane·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Optimising TREATment for Severe Gram-Negative Bacterial Infectionsn = —

National University of Singapore·—·Phase 4

Design: —
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Dosing: —
Eligibility: —

Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus Aureus Bacteraemian = —

Clinical Research Centre, Malaysia·—·Phase 3

Design: —
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Eligibility: —

Management of Shock in Children With SAM or Severe Underweight and Diarrhean = —

International Centre for Diarrhoeal Disease Research, Bangladesh·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Dalbavancin Versus Standard Antibiotic Therapy for Catheter-related Bloodstream Infections Due to Staphylococcus Aureusn = —

Assistance Publique - Hôpitaux de Paris·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantationn = —

Mundipharma Research Limited·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Combination Therapy With Ceftazidime and Fosfomycin Will be Compared to Ceftazidime Alone in Hospitalized Adult Patients With Suspected Severe Gram-negative Bacterial Infectionsn = —

Angela HUTTNER·—·Phase 3

Design: —
Primary endpoint: —
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Eligibility: —

Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Carbapenem-Resistant Enterobacteriaceae Infectionsn = —

Qilu Pharmaceutical Co., Ltd.·—·Phase 3

Design: —
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Eligibility: —

Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonatesn = —

Indian Council of Medical Research·—·Phase 3

Design: —
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Eligibility: —

Pivmecillinam With Amoxicillin/Clavulanic Acid for Step Down Oral Therapy in ESBL UTIsn = —

Lund University·—·Phase 3

Design: —
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Eligibility: —

A Randomized Study of a Short Duration Therapy for Candidemian = —

Assistance Publique - Hôpitaux de Paris·—·Phase 3

Design: —
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Dosing: —
Eligibility: —

A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.n = —

Basilea Pharmaceutica·—·Phase 3

Design: —
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STeroids and Enhanced Spectrum Antibiotics for the Treatment of Patients in Africa With Refractory Sepsisn = —

University of Virginia·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Womenn = —

Minervax ApS·—·PHASE2/PHASE3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Pentaglobin in CRE and PA Neutropenic Infectionsn = —

Gruppo Italiano Trapianto di Midollo Osseo·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremian = —

Todd C. Lee MD MPH FIDSA·—·Phase 2

Design: —
Primary endpoint: —
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Eligibility: —

Safety and Efficacy of Interferon-Gamma 1b in Patients With Candidemian = —

Radboud University Medical Center·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Safety, Pharmacokinetics and Efficacy of BV100 Plus Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol in Patients With Pulmonary and Extrapulmonary Infections Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complexn = —

BioVersys AG·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)n = —

AstraZeneca·—·PHASE1/PHASE2

Design: —
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Eligibility: —