RECCE 327 / Recce Pharma - LARVOL DELTA

An Open-Label Study to Evaluate the Systemic Pharmacokinetics and Bioavailability of Single and Multiple Doses of RECCE®327 Topical Gel Applied to Normal Intact Skin in Healthy Male and Female Participants (ANZCTR) - P1 | N=12 | Completed | Sponsor: Recce Pharmaceuticals LTD | Recruiting ➔ Completed

Trial completion • Infectious Disease

Recce Pharmaceuticals Reports Positive Data from Phase II Trial of RECCE 327 Gel in Acute Bacterial Skin and Skin Structure Infections, Supporting Accelerated Commercialization Pathway (GlobeNewswire) - P2 | N=30 | ACTRN12624000973516 | Sponsor: Recce Pharmaceuticals Limited | "The Phase II trial successfully demonstrated R327G achieving a 93% primary efficacy endpoint over 14 days, meeting all study endpoints. After 7 days of treatment, 86% of patients (25 out of 29) treated with R327G had a successful clinical response. At 14 days of treatment, 93% of patients (27 out of 29) achieved a primary efficacy endpoint. R327G demonstrated to be safe and well tolerated, with no serious adverse events (SAE) reported, achieving all endpoints...This Phase II study achieved all primary and secondary endpoints as an open-label clinical trial evaluating the safety, tolerability, efficacy, and plasma pharmacokinetics of R327G when applied directly to the infected area."

P2 data • Infectious Disease

An Open-Label Study to Evaluate the Systemic Pharmacokinetics and Bioavailability of Single and Multiple Doses of RECCE®327 Topical Gel Applied to Normal Intact Skin in Healthy Male and Female Participants (ANZCTR) - P1 | N=12 | Recruiting | Sponsor: Recce Pharmaceuticals LTD

New P1 trial • Infectious Disease

RECCE®327 Topical Gel Study for the clinical indication of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) (ANZCTR) - P2 | N=30 | Recruiting | Sponsor: Recce Pharmaceuticals Limited | Not yet recruiting ➔ Recruiting | Initiation date: Aug 2024

Enrollment open • Trial initiation date • Infectious Disease

RECCE®327 Topical Gel Study for the clinical indication of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) (ANZCTR) - P2 | N=30 | Not yet recruiting | Sponsor: Recce Pharmaceuticals Limited

New P2 trial • Infectious Disease

Proof of concept study of RECCE®327 topical anti-infective therapy for mild skin and soft tissue diabetes foot infections (DFIs) (ANZCTR) - P1/2 | N=32 | Terminated | Sponsor: Recce Pharmaceuticals | Recruiting ➔ Terminated

Trial termination • Diabetes • Infectious Disease • Metabolic Disorders

An Open Label, Adaptive Design Evaluation, Crossover Study of the Safety, Pharmacokinetics and Pharmacodynamics of Various RECCE®327 Intravenous Dose and Infusion Rates (ANZCTR) - P1 | N=16 | Recruiting | Sponsor: Recce Pharmaceuticals Ltd | Initiation date: Jun 2000 ➔ Jun 2023

Trial initiation date • Infectious Disease • Nephrology • Urology

Proof of concept study of RECCE®327 topical anti-infective therapy for mild skin and soft tissue diabetes foot infections (DFIs) (ANZCTR) - P1/2 | N=32 | Recruiting | Sponsor: Recce Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Trial initiation date • Diabetes • Infectious Disease • Metabolic Disorders

An Ascending-dose, Randomized, Placebo-controlled, Parallel, Double-blind, Single-dose, First-in-Human Study to Evaluate the Safety and Pharmacokinetics of RECCE®327 in Healthy Male Subjects (ANZCTR) - P1; N=120; Not yet recruiting; Sponsor: Recce Pharmaceuticals, Ltd.

Clinical • New P1 trial • Infectious Disease

[VIRTUAL] Elucidating the Mechanism of Action of Novel Polymer-based Synthetic Anti-infective Compound Recce® 327 (WMF 2021) - "Finally, we found that R327 led to a rapid decrease in viable stationary phase cells that were not actively growing. These studies strongly indicate that R327 is rapidly and irreversibly bactericidal to both active and slow-growing cells and that it acts by disrupting cellular bioenergetics, potentially by disrupting the membrane potential and/or ATP synthesis."

Late-breaking abstract • Complement-mediated Rare Disorders • Infectious Disease

Recce Pharmaceuticals Completes Capital Raising of $27.95 Million (GlobeNewswire) - "Recce Pharmaceuticals Ltd...is pleased to announce it has raised A$27,950,000 (before costs)...that will result in 21,500,000 full paid ordinary shares being issued at A$1.30 per share (Placement)....Additional support by the Australian Government’s 43.5% R&D rebate on R&D applicable activities, ensures the Company is fully funded to complete its Phase I human clinical trial....Funds will also be used to support regulatory submissions and general corporate purposes."

Financing • Infectious Disease • Novel Coronavirus Disease