Recce Pharmaceuticals Announces Positive Safety Data from Seventh Cohort of Phase 1 Clinical Trial Evaluating Healthy Subjects Intravenously Dosed with RECCE® 327

Highlights:

• 10 subjects in cohort seven were intravenously dosed with RECCE^® 327 at 6,000mg
• Independent Safety Committee reviewing cohort seven data and anticipate a recommendation to proceed to cohort eight
• Overall study objectives achieved with a focus on establishing a dose ceiling
• Phase 2 protocol under development based upon efficacious doses determined in previous animal studies

SYDNEY, Australia, Aug. 23, 2022 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX:RCE, FSE:R9Q) (the Company), the company developing a new class of synthetic anti-infectives, is pleased to report that in cohort seven of a Phase 1 clinical trial, RECCE^® 327 (R327) intravenously dosed at 6,000mg (a 120-fold increase from cohort one at 50mg) over a 1-hour infusion demonstrated no serious adverse effects among 10 healthy male subjects.

An Independent Safety Committee is reviewing cohort seven data and is expected to recommend the initiation of cohort eight. Recce reports 6,000mg as broadly efficacious in previous animal studies with Phase 2 protocol under development.

“We are thrilled to have completed dosing of 6,000mg (6 grams) via a 1-hour I.V. infusion in our Phase 1 clinical trial,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals Ltd. “Achieving a 120-fold increase from cohort one at 50mg with anticipation to soon initiate cohort 8 continues to build the safety and tolerability profile of R327 as a potential new treatment option.”

The Phase 1 trial is an ascending dose, randomized, placebo-controlled, parallel, double-blind, single-dose study conducted at Adelaide's CMAX clinical trial facility. The study is evaluating the safety and pharmacokinetics of R327 in 7-10 healthy subjects per dose across eight sequential dosing cohorts (Trial ID ACTRN12621001313820).

According to PEW Charitable Trusts global antibiotic pipeline review, R327 is the only clinical-stage new class of antibiotic in the world being developed for sepsis, the largest unmet medical need in human health.¹

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^{1 https://www.pewtrusts.org/en/research-and-analysis/data-visualizations/2017/nontraditional-products-for-bacterial-infections-in-clinical-development}

About Recce Pharmaceuticals Ltd

Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) is developing a New Class of Synthetic Anti-Infectives designed to address the urgent global health problems of antibiotic-resistant superbugs and emerging viral pathogens.

Recce’s anti-infective pipeline includes three patented, broad-spectrum, synthetic polymer anti-infectives: RECCE^® 327 as an intravenous and topical therapy that is being developed for the treatment of serious and potentially life-threatening infections due to Gram-positive and Gram-negative bacteria including their superbug forms; RECCE^® 435 as an orally administered therapy for bacterial infections; and RECCE^® 529 for viral infections. Through their multi-layered mechanisms of action, Recce’s anti-infectives have the potential to overcome the hypercellular mutation of bacteria and viruses – the challenge of all existing antibiotics to date.

The FDA has awarded RECCE^® 327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act – labelling it for Fast Track Designation, plus 10 years of market exclusivity post approval. Further to this designation, RECCE^® 327 has been included on The Pew Charitable Trusts Global New Antibiotics in Development Pipeline as the world’s only synthetic polymer and sepsis drug candidate in development. RECCE^® 327 is not yet market approved for use in humans with further clinical testing required to fully evaluate safety and efficacy.

Recce wholly owns its automated manufacturing, which is supporting present clinical trials. Recce’s anti-infective pipeline seeks to exploit the unique capabilities of its technologies targeting synergistic, unmet medical needs.

Corporate Contact
James Graham
Recce Pharmaceuticals Ltd
+61 (02) 9256 2571
James.graham@recce.com.au

Media and Investor Relations (AU)
Andrew Geddes
CityPR
+61 (02) 9267 4511
ageddes@citypublicrelations.com.au

Media and Investor Relations (USA)
Jordyn Temperato
LifeSci Communications
jtemperato@lifescicomms.com