Dose increase of R327
36 subjects successfully dosed in Phase I intravenous (IV) clinical trial of RECCE® 327 (R327) – demonstrating good safety and tolerability at 1,000mg
Independent Safety Committee affirms ‘low-dose’ cohort clinical trial complete, endpoints achieved – recommends ‘high dose’ cohort dosing to begin
Committee clears cohort five (R327 – 2,000mg IV) dosing – subjects recruited and dosing underway
SYDNEY, Australia, April 13, 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 an Independent Safety Committee data review of 10 healthy human subjects dosed in a Phase I intravenous (IV) clinical trial of RECCE® 327 (R327), demonstrating good safety and tolerability at 1,000mg. The ‘low-dose’ cohorts data review is complete, with all endpoints achieved and a unanimous recommendation to start ‘high-dose’ cohort five at 2,000mg.
Dose increase of R327
“Completing 1,000mg dosing and maintaining a good safety and tolerability profile among 36 subjects in all cohorts is ideal for ‘low-dose’ cohorts achieving clinical endpoints,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals. “Recommendation to commence ‘high dosing’ at 2,000mg, a 40-fold increase from the initial dosing of 50mg in cohort one, by the Independent Safety Committee is a welcome validation with subject dosing now underway.”
The Phase I trial is an ascending dose, randomized, placebo-controlled, parallel, double-blind, single-dose study being 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 of 50-16,000mg (Trial ID ACTRN12621001313820). The study is on track to complete all Phase I dosing by Q2 2022.
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
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.
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A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/37ce1a43-5e42-42e6-ab6d-a6d1e6cd5907