Recce Pharmaceuticals — Positive R327G Phase II ABSSSI study results
Recce Pharma

Recce Pharmaceuticals (ASX: RCE)

Last close As at 20/02/2025

AUD0.44

−0.01 (−1.14%)

Market capitalisation

AUD103m

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Research: Healthcare

Recce Pharmaceuticals — Positive R327G Phase II ABSSSI study results

Recce has reported positive results from its open-label Phase II study assessing RECCE® 327 topical gel (R327G) in patients with acute bacterial skin and skin structure infections (ABSSSI), including patients with diabetic foot infections (DFIs). In 29 evaluable patients, the company reported a 93% primary efficacy endpoint with R327G treatment over 14 days. In our view, these results bode well for the company’s Phase III registrational study in Indonesia assessing R327G as a treatment for DFIs. We expect patient dosing and recruitment to start imminently given the late CY24 approval for the study to commence from the Indonesian Drug and Food Regulatory Authority, Badan POM. If the results are positive, Recce could potentially launch R327G in South-East Asia in H2 CY26, marking the company’s transition to commercial stage.

Jyoti Prakash

Written by

Jyoti Prakash, CFA

Analyst, Healthcare

Healthcare

Study results

20 February 2025

Price AUD0.450
Market cap AUD104m

Estimated net cash/(debt) at 31 December 2024

AUD(0.7)m

Shares in issue

231.9m
Code RCE
Primary exchange ASX
Secondary exchange FSE
Price Performance

Business description

Recce Pharmaceuticals is an Australian company developing its novel, broad-spectrum synthetic polymer anti-infective drugs for the treatment of several infectious diseases, including sepsis, acute bacterial skin and skin structure infections, diabetic foot infections, burn wound infections and urinary tract infections.

Analysts

Jyoti Prakash, CFA
+44 (0)20 3077 5700
Pooya Hemami, OD MBA, CFA
+44 (0)20 3077 5700

Recce Pharmaceuticals is a research client of Edison Investment Research Limited

Note: PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments. Revenue figures reflect gross revenues.

Year end Revenue (AUDm) PBT (AUDm) EPS (AUD) DPS (AUD) P/E (x) Yield (%)
6/23 4.3 (13.1) (0.08) 0.00 N/A N/A
6/24 4.9 (17.8) (0.10) 0.00 N/A N/A
6/25e 10.1 (16.2) (0.07) 0.00 N/A N/A
6/26e 6.0 (71.9) (0.31) 0.00 N/A N/A

In the Phase II ABSSSI trial, R327G was applied once daily for seven days to the site of infection, followed by safety and efficacy evaluations. A possible additional seven-day R327G treatment period was considered at the investigator’s discretion if indicated, with repeated safety and efficacy evaluations.

The study achieved all primary and secondary efficacy endpoints and met plasma pharmacokinetics (PK) expectations. After seven days of treatment, 86% of patients (25 of 29) treated with R327G had a successful clinical response, and at 14 days of treatment, 93% of patients (27 of 29) achieved a primary efficacy endpoint. Clinical outcomes were assessed using the Lipsky Clinical Resolution of Infection Scale and/or the Bates Jensen Wound Assessment tool, both FDA-recognised measures. R327G was reported to be safe and well tolerated, with no serious adverse events. The study enrolled 30 patients in total, with one withdrawing due to pre-existing pain at the wound site that was deemed unrelated to R327G.

These results were consistent with interim data on 20 patients released in November, whereby all patients who completed R327G treatment at that time had achieved positive outcomes, showing either complete cure or notable improvement.

While the company has not yet reported the breakdown in treatment efficacy by specific ABSSSI condition type, given the high response rates shown, it anticipates that its Indonesian registrational Phase III DFI study may reach a statistically significant efficacy result after completing treatment of c 100 patients (compared to the trial’s planned enrolment of 300 patients). Recce expects to report interim data (on c 100 patients) from the Phase III study, consistent with the Badan POM-approved study protocol, by the end of CY25.

The global ABSSSI market was valued by Fortune Business Insights at US$7.3bn in 2018 and is projected to reach US$25.9bn in 2032. Recce also plans to start an Australian Phase III R327G study in ABSSSI and/or DFIs in CY25, and we await further details on this programme (as well as on a possible study including US trial sites) in the coming weeks.

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