Recce Pharmaceuticals has announced the conclusion of subject dosing in the latest cohort of its Phase I/II clinical trial of RECCE 327 (R327) for the treatment of urinary tract infections (UTI) and urosepsis.
The adaptive, open-label, crossover study aims to assess the safety, pharmacokinetics, and pharmacodynamics of various intravenous doses and infusion rates of R327.
Recce is exploring multiple infusion times ranging from 15 to 60 minutes at a dose of 3,000mg, considered to be within R327's optimal therapeutic window.
The safety of the 3,000mg dose has been confirmed by the company when administered over various infusion times between 15 and 60 minutes in trial participants.
The efficacy results of R327, administered intravenously, will be available upon the completion of the Phase I/II trial, following the study protocol.
Recce noted that the primary outcome of the trial is to evaluate the safety and tolerability of the therapy doses ranging from 2,000mg to 3,000mg at infusion rates between 15 and 45 minutes in healthy male and female subjects.
The study includes up to four cohorts, with four participants at each dose level.
An Independent Safety Committee is now set to review the comprehensive data from the four-subject cohort, with recruitment for the next cohort already in progress.
R327 received the Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act from the US Food and Drug Administration (FDA), which includes fast track status and ten years of market exclusivity post-approval.
Additionally, it has been listed on The Pew Charitable Trusts Global New Antibiotics in Development Pipeline as the only synthetic polymer and sepsis drug candidate in development.
Apart from R327, Recce has two patented, broad-spectrum, synthetic polymer anti-infectives in its pipeline namely, RECCE 435 for bacterial infections and RECCE 529 for viral infections.
Recce Pharmaceuticals CEO James Graham said: “Completing dosing for our latest cohort marks another milestone in our journey advancing R327 as a potential frontline treatment for UTI/urosepsis.
“We are dedicated to delivering impactful solutions to combat infectious diseases and improve global health outcomes globally."
