News and Announcements
Phase I Clinical Trial of RECCE® 327 Advances to High Dose Level (2,000mg I.V)
- Published April 22, 2022 12:00AM UTC
- Publisher Wholesale Investor
- Categories Company Updates
Highlights:
- 36 human subjects successfully dosed in the Phase I intravenous (IV) clinical trial of RECCE® 327 (R327) – good safety & tolerability
- Independent Safety Committee affirms ‘low-dose’ cohort clinical trial complete, end-points achieved – recommends ‘high dose’ cohort dosing to begin
- Committee clears Cohort 5 (R327 – 2,000mg IV) dosing start – subjects recruited and dosing underway
SYDNEY Australia, 12 April 2022: 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 the Phase I intravenous (IV) clinical trial of RECCE® 327 (R327), demonstrating good safety and tolerability at 1,000mg. ‘Low-dose’ cohorts data review complete, end-points achieved with unanimously recommendation to start ‘high-dose’ Cohort 5 (R327, 2,000mg IV).
James Graham, Chief Executive Officer of Recce Pharmaceuticals Ltd said, “Completing 1,000mg (R327 I.V) dosing, maintaining a good safety & tolerability profile among 36 human subject all cohorts – ideal completion of ‘low-dose’ cohorts seeing achieving clinical end-points. Recommendation to commence ‘high dosing’ at 2,000mg – a 40-fold increase from initial dosing of 50mg in Cohort 1 by the independent safety committee is a welcome validation with first human subject dosing now underway”.
The Phase I trial is an ascending dose, randomised, 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.
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