News and Announcements
Positive Safety Data from Third Cohort of Phase I Clinical Trial Evaluating Healthy Subjects Intravenously Dosed with RECCE® 327
- Published February 18, 2022 12:00AM UTC
- Publisher Wholesale Investor
- Categories Company Updates
Highlights:
- 7 subjects in Cohort Three intravenously dosed; RECCE® 327 at 500mg indicating to be safe and well tolerated
- Minimum recruited subjects met (7); additional three (3) at this milestone requested to maximise key data set – expected within two weeks
- Independent Safety Committee to review at study completion – expect recommendation to proceed – Cohort Four recruitment underway
SYDNEY Australia, 8 February 2022: Recce Pharmaceuticals Ltd (ASX:RCE, FSE:R9Q) (the Company), the Company developing New Classes of Synthetic Anti-infectives, is pleased to report Phase I intravenous (IV) clinical trial of RECCE® 327 (R327) Cohort Three at 500mg (tenfold increase on cohort one 50mg dose), indicating a good safety and tolerability profile among 7 healthy male subjects.
James Graham, Chief Executive Officer of Recce Pharmaceuticals Ltd said, “Indications of R327 being safe and well tolerated at 500mg IV is a wonderful milestone for the Company. These results are an excellent outcome for this clinically-invasive method of administration, with a few additional participants to strengthen a compelling safety profile, and serves well for regulatory and synergistic program potential.”
Cohort Three (R327 – 500mg) – Demonstrated Safety and Tolerability
R327 was indicated to be safe and well tolerated at 500mg with no clinically significant changes in vital signs or adverse events associated with R327.
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 have all Phase I dosing complete 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.
About Recce Pharmaceuticals Ltd (ASX: RCE)
Recce Pharmaceuticals Ltd (ASX: RCE) is pioneering the development and commercialisation of a new class of synthetic antibiotics with broad-spectrum activity designed to address the urgent global health problem of antibiotic-resistant superbugs.
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