Trial progresses of RECCE 327 for UTI and urosepsis
The study is assessing RECCE 327 across the infusion times of 15, 20, 30, 45, and 60 minutes at the dose level of 3000 mg.
A phase 1/2 trial (ACTRN12623000448640) of RECCE 327 (R327), a therapy for the management of urinary tract infection (UTI) and urosepsis, has dosed the next cohort of patients at the dose level of 3000 mg and an infusion rate of 20 minutes, according to a news release from Recce Pharmaceuticals, the developer of the treatment.1
R327 was awarded a Qualified Infectious Disease Product (QIDP) designation by the FDA in 2017.
Overall, the study is assessing the therapy across the multiple infusion times of 15, 20, 30, 45, and 60 minutes at the dose level of 3000 mg. Previous data has determined that R327 is safe when administered to participants at 3000 mg at varying infusion times between 15 and 60 minutes.2 Efficacy data will be made available at the time of study completion, according to Recce Pharmaceuticals.
“We're pleased to continue advancing the clinical profile of R327, which has demonstrated safe and efficacious potential against a broad range of antibiotic-resistant pathogens across multiple studies,” said James Graham, CEO of Recce Pharmaceuticals, in the news release.1 “We've observed efficacy when applied topically to patients with diabetic foot ulcer infections, and the additional infusion time at 3,000mg over 20 minutes in this study highlights a compelling safety profile with the potential to treat the millions of patients worldwide that suffer from UTIs or urosepsis each year.”
With the dosing of patients at the 20-minute infusion time, the phase 1/2 study has now assessed R327 across 4 infusion times. The company noted that the trial dosing timestamps have been in line with intended future regulatory submissions.
Participants in the study will be enrolled through clinical trial sites in Australia.
To be included in the trial, participants must be healthy, aged 18 to 65, and have a body mass index between 18 and 35 kg/m² and a body weight not less than 50 kg and no more than 120 kg. Additionally, those included in the study must agree to urethral catheterization of the bladder for each dosing period, and women of childbearing potential must agree to highly effective forms of contraception for the duration of treatment, plus 30 days following the last treatment administration.
Participants will be excluded from the trial if they are currently pregnant or breastfeeding, have a history of or currently have phlebitis, thrombophlebitis, or a clinically significant medical history of condition, received a vaccination 14 days prior to first study dose, have used any investigational products within 30 days prior to first study dose, or have had alcohol or substance abuse within the 6 months prior to screening.
The primary end points for the study include the safety and tolerability of R327 administered via intravenous infusion, as well as the plasma pharmacokinetics of the therapy in healthy participants. Secondary outcome measures include the concentration of R327 in the urine and the ex vivo pharmacodynamics of urine and blood from healthy participants.
R327 was awarded a Qualified Infectious Disease Product (QIDP) designation by the FDA in 2017 as part of the Generating Antibiotic Initiatives Now (GAIN) Act.3 The QIDP designation also includes a label for Fast Track designation. Further clinical trial data on the safety and efficacy of R327 is needed in order to file for market approval in the US.
References
1. Recce Pharmaceuticals doses next cohort in phase I/II trial of RECCE 327 for urinary tract infections and urosepsis. News release. Recce Pharmaceuticals. Published online and accessed March 14, 2024. https://www.globenewswire.com/news-release/2024/03/14/2846219/0/en/Recce-Pharmaceuticals-Doses-Next-Cohort-in-Phase-I-II-Trial-of-RECCE-327-for-Urinary-Tract-Infections-and-Urosepsis.html
2. Recce Pharmaceuticals announces safety committee approves faster infusion rate in phase I/II trial of RECCE 327 for urinary tract infections and urosepsis. News release. Recce Pharmaceuticals. October 25, 2023. Accessed March 14, 2024. https://www.globenewswire.com/en/news-release/2023/10/25/2766465/0/en/Recce-Pharmaceuticals-Announces-Safety-Committee-Approves-Faster-Infusion-Rate-in-Phase-I-II-Trial-of-RECCE-327-for-Urinary-Tract-Infections-and-Urosepsis.html
3. Recce Ltd. U.S. FDA Grants Qualified Infectious Disease Product Designation for RECCE 327. News release. Recce Ltd. November 16, 2017. Accessed March 14, 2024. https://www.biospace.com/article/releases/recce-ltd-u-s-fda-grants-qualified-infectious-disease-product-designation-for-recce-327/
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