- Recce Pharmaceuticals (RCE) is set to administer its “high dose” cohort following its successful phase one clinical trial of R327 in the “low dose” cohort
- The 10 healthy human subjects administered with R327 in the “low dose” cohort showed good safety and tolerability of the antibiotic at 1000mg
- The study is on track to have all phase one dosing complete by the end of Q2, 2022
- R327 is believed to be the only clinical-stage new class of antibiotic in the world being developed for sepsis, the largest unmet medical need in human health
- RCE shares have ended the day down 1.06 per cent at 93 cents
Recce Pharmaceuticals (RCE) has been cleared to administer a “high dose” cohort following its successful phase one clinical trial of RECCE 327 (R327) in the “low dose” cohort.
The 10 healthy human subjects in the “low dose” cohort demonstrated good safety and tolerability of R327 at 1000 milligrams (mg), an independent safety committee data review found.
To date, 36 human subjects were successfully dosed intravenously in phase one and have reported no issue.
“Completing 1000mg (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,” CEO James Graham said.
“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.”
R327 is believed to be the only clinical-stage new class of antibiotic in the world being developed for sepsis, the largest unmet medical need in human health.
The phase one 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 seven to 10 healthy subjects per dose, across eight sequential dosing cohorts of 50 to 16000 mg.
The study is on track to have all phase one dosing complete by Q2, 2022.
RCE shares were down 1.06 per cent, ending the day at 93 cents.