- Recce Pharmaceuticals (RCE) reports positive safety results from the fourth patient cohort in a first-phase trial of its RECCE 327 (R327) synthetic anti-infective
- The drug developer dosed 10 healthy male subjects with 1000mg of R327 as part of the trial, with R327 indicated to be safe and well-tolerated in all subjects
- The 1000mg dose is a twenty-fold increase on the initial dose of 50mg given to the first patient cohort back in January
- An independent safety committee will now review the data from the fourth cohort of subjects to determine if the trial can move ahead to the next cohort
- Shares in Recce Pharmaceuticals close 0.53 per cent higher at 96 cents per share
Recce Pharmaceuticals (RCE) has reported positive safety results from the fourth of eight planned patient cohorts in a first-phase trial of its RECCE 327 (R327) synthetic anti-infective.
The drug developer dosed 10 healthy male subjects with 1000mg of R327 as part of the trial. Recce said R327 was indicated to be safe and well-tolerated in all subjects, with no clinically significant changes in vital signs or adverse events associated with the drug recorded in the cohort.
The 1000mg dose is a twenty-fold increase on the initial dose of 50mg given to the first patient cohort back in January.
Recce CEO James Graham said achieving a dosing level of 1000mg was a “significant milestone” for the company.
“Indicating R327 to be safe and well-tolerated at a twenty-fold increase of the initial dosing level of 50mg is pleasing, not only for the unmet medical need of sepsis but so too for synergies across our wider infectious disease portfolio,” Mr Graham said.
An independent safety committee will now review the data from the fourth cohort of subjects to determine if the trial can move ahead to the next cohort. Recce said it was expecting to receive a recommendation to proceed from the safety committee, and so the company has already started patient recruitment for the fifth cohort.
R327 is a broad-spectrum anti-infective designed to treat several families of bacteria. Recce said according to PEW Charitable Trusts global antibiotic pipeline review, R327 was the only clinical-stage new class of antibiotics being developed as a treatment for sepsis.
Shares in Recce Pharmaceuticals closed 0.53 per cent higher this afternoon at 96 cents per share. The company has a $166 million market cap.