Recce Pharmaceuticals Reports Phase II ABSSSI Trial Interim Data and Safety Approval

Recce Pharmaceuticals Ltd recently announced that an independent non-Data Safety Monitoring Board (non-DSMB) reviewed the safety and efficacy data from the Phase II clinical trial of RECCE® 327 Gel (R327G). This trial focused on patients with acute bacterial skin and skin structure infections (ABSSSI), including diabetic foot infections (DFI). The findings demonstrated highly promising results, confirming the safety and potential efficacy of R327G.

Professor Eugene Athan, Coordinating Principal Investigator of the study, highlighted the encouraging outcomes observed in the interim data, which suggest that R327G could effectively treat ABSSSI, including DFI. The non-DSMB's review concluded there were no significant safety concerns, and they recommended the continuation of the clinical trial, which is expected to be finished by year-end.

James Graham, Chief Executive Officer of Recce Pharmaceuticals, expressed optimism regarding the feedback from the non-DSMB. He emphasized the importance of the absence of serious adverse events and the broad-spectrum efficacy observed in challenging wound infections, reinforcing R327G's potential to address unmet medical needs in treating serious bacterial infections.

The non-DSMB's positive evaluation was based on R327G's excellent safety profile, with no serious adverse events reported among patients. The efficacy results were highly encouraging, with all patients meeting the primary endpoint by achieving complete cure or improvement, some as early as 7 days. These outcomes were measured using the Lipsky Clinical Resolution of Infection Scale, a recognized tool for assessing infection resolution, particularly in diabetic foot infections.

The variety of conditions treated included diabetic foot ulcer, eczema, scratches, and puncture wound infections. A wide array of bacteria (both Gram positive and Gram negative) were isolated and successfully treated, resulting in infection improvement or cure in all patients who continued with their treatment. Specific patient responses included:

- Patient 188 (Male) - Cure by Day 7
- Patient 253 (Male) - Cure by Day 7
- Patient 349 (Male) - Cure by Day 7
- Patient 463 (Female) - Cure by Day 7
- Patient 546 (Male) - Cure by Day 14
- Patient 663 (Female) - Cure by Day 14
- Patient 767 (Male) - Improvement by Day 7
- Patient 872 (Male) - Improvement by Day 7
- Patient 970 (Male) - Improvement by Day 7
- Patient 1059 (Male) - Improvement by Day 7
- Patient 1163 (Male) - Improvement by Day 7
- Patient 1268 (Male) - Improvement by Day 14
- Patient 1381 (Female) - Withdrawn due to pain at the wound site, unlikely related to R327G
- Patient 1484 (Female) - Improvement by Day 14

The global market for ABSSSI treatment was valued at $7.3 billion USD in 2018 and is projected to reach $26 billion USD by 2032, growing at a compound annual growth rate (CAGR) of 9.5% from 2019 to 2032.

The Phase II clinical trial, titled “Open-label, Pilot Efficacy Study and Exploratory Evaluation of the Systemic Bioavailability of Single and/or Multiple Doses of R327 as a Topical Gel Applied to Acute Bacterial Skin and Skin Structure Infections” (Trial ID ACTRN12624000973516), is designed to evaluate the efficacy and systemic absorption of R327G when applied directly to infected areas.

Recce Pharmaceuticals Ltd is committed to developing a new class of synthetic anti-infectives aimed at addressing urgent global health issues related to antibiotic-resistant superbugs and emerging viral pathogens. Their anti-infective pipeline includes RECCE® 327 (R327) for intravenous and topical treatment of serious bacterial infections, RECCE® 435 (R435) for oral treatment of bacterial infections, and RECCE® 529 (R529) for viral infections. These anti-infectives, with their multi-layered mechanisms of action, offer the potential to overcome the resistance processes utilized by bacteria and viruses, a critical challenge with existing antibiotics.

The World Health Organization (WHO) has recognized Recce’s efforts by adding R327, R435, and R529 to its list of antibacterial products in clinical development for priority pathogens. The FDA has granted R327 the Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act, providing Fast Track Designation and market exclusivity post-approval. Recce also owns its automated manufacturing, supporting current clinical trials and aiming to address synergistic, unmet medical needs with its innovative technologies.