- Recce Pharmaceuticals’ (RCE) new class of synthetic anti-infectives drug, the RECCE 327 (R327) has been given the go-ahead for the next set of doses by an Independent Safety Committee (ISC) following a successful Phase I intravenous (IV) clinical trial of 10 healthy human subjects
- The intravenous dose concluded that the drug demonstrated good safety and tolerability; the study evaluated R327 across eight sequential dosing cohorts of 50-16,000 milligrams in 7-10 healthy subjects per dose.
- 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
- The study is on track to have all Phase I dosing complete by Q2 2022
- RCE shares are up 2.19 per cent, reporting at 93.5 cents
An Independent Safety Committee has recommended that Recce Pharmaceuticals’ (RCE) new class of synthetic anti-infectives medicine, RECCE 327 (R327), be approved for the next round of dosing following a successful Phase I intravenous (IV) clinical study.
The ISC conducted a review of 10 healthy human subjects that were intravenously dosed in Phase I of R327 and concluded that the drug demonstrated good safety and tolerability.
The Phase I trial was conducted at Adelaide’s CMAX clinical trial facility and given in an ascending dose.
RCE CEO James Graham believes that being given the go-ahead is a “wonderful endorsement for the compelling Safety and Tolerability profile demonstrated among the 10 subjects”.
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.
The study conducted evaluates the safety and pharmacokinetics of R327 in 7-10 healthy subjects per dose, across eight sequential dosing cohorts of 50-16,000 milligrams.
The study is on track to have all Phase I dosing complete by Q2 2022.
RCE shares were up 2.19 per cent, reporting at 93.5 cents at 12:55 pm AEDT.