Highlights:
- Nine subjects in cohort one intravenously dosed with RECCE® 327 at 50mg meets all endpoints, indicating to be safe and well tolerated
Independent Safety Committee clears second study cohort dosing at 150mg - a threefold increase in dose per approved protocol- Second cohort recruited; healthy subjects dosed
January 7, 2022
“R327 continues to make significant progress in the clinic, both in this Phase I intravenous trial and a parallel Phase I/II topical trial on patients with serious burn wound infections,” said
Cohort One (R327 - 50mg) Complete – Demonstrated Safety and Tolerability
R327 was shown to be safe and well tolerated at the 50mg dose with no clinically significant changes in vital signs, adverse events, or laboratory parameters associated with R327.
The Phase I trial is an ascending dose, randomized, placebo-controlled, parallel, double-blind, single-dose study being conducted at
According to
About
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
+61 (02) 8075 4585
James.graham@recce.com.au
Media and Investor Relations (AU)
CityPR
+61 (02) 9267 4511
ageddes@citypublicrelations.com.au
Media and Investor Relations (
jtemperato@lifescicomms.com
1 https://www.pewtrusts.org/en/research-and-analysis/data-visualizations/2017/nontraditional-products-for-bacterial-infections-in-clinical-development
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