- Recce Pharmaceuticals (RCE) reports positive safety data in ten male subjects who received 4000mg of Recce’s R327 product as part of a first-phase clinical trial
- The subjects are part of the sixth cohort to be intravenously dosed with R327, and the 4000mg dose marks an 80-fold increase from the first cohort
- Recce says that based on today’s results, it expects an independent safety committee to recommend the commencement of recruitment for cohort seven
- The company says the study is on track to have all phase-one dosing completed by the second quarter of 2022
- Shares in Recce Pharmaceuticals are up 22.12 per cent and trading at 69 cents at 2:05 pm AEST
Recce Pharmaceuticals (RCE) has reported positive safety data in ten male subjects who received 4000mg of Recce’s R327 product as part of a first-phase clinical trial.
The subjects were part of the sixth cohort to be intravenously dosed with R327, and the 4000mg dose marks an 80-fold increase from the first cohort, which was dosed with 50mg of R327.
Recce said it observed good safety and tolerability among the 10 subjects in this sixth cohort, meaning the company expects an independent safety committee to recommend the commencement of recruitment for cohort seven based on today’s results.
CEO James Graham said the company was pleased with the data that “strongly” supported the potential of R327 as a new treatment option for patients with sepsis.
“We look forward to continuing to work with the independent safety committee and further evaluating RECCE 327’s safety and tolerability profile in additional cohorts,” Mr Graham said.
The trial is a randomised, placebo-controlled, single-dose study evaluating the safety and pharmacokinetics of R327 in up to ten healthy subjects per dose, across eight sequential dosing cohorts of 50 to 16000 mg.
According to Recce, R327 is the only clinical-stage new class of antibiotics in the world being developed for sepsis — the largest unmet medical need in human health.
The company says the study was on track to have all phase one dosing complete by the second quarter of 2022.
All trials so far have been conducted at Adelaide’s CMAX clinical trial facility.
Shares in Recce Pharmaceuticals were up 22.12 per cent and trading at 69 cents at 2:05 pm AEST.