When I read through each of the announcements that relate to the progress of the sepsis study, and its subsequent UTI spinoff study I see the timelines all being fairly clearly signalled. I have not been ticking them off on my calendar however. Are you saying that the initial timelines for these studies were not fulfilled, and if not, that they were not
remotely within a framework that is reasonable or acceptable?
I see that the UTI trial was an unexpected spinoff from the sepsis trial, so could be expected to add sequentially to the timeframe. None of these trials seem to be substantially slow to progress nor to complete, given the need to ensure the safety of the recipients of the drug.
So again, are you saying that the
ex vivo UTI trial was inappropriately conceived and planned to obtain meaningful results? This is despite it having been reviewed and approved by definitively and significantly trustworthy medical expertise to test the things it was aimed at showing. I am not suitably qualified to even begin to make such an assertion, but something tells me that you are not either.
These are the people who have now approved its use on
actual patients with actual UTI, having established its safety and efficacy envelopes via those trials. That is encouraging, to me at least.
Having read a bunch of your posts on RCE it is clear that the tenor of them is critical, even scathingly dismissive, while encouraging of others to concur with your perspective. You are basically saying to me and to other HC readers that we should accept and trust your significantly critical judgements and statements rather than those of the company or its medical associates that are conducting and reviewing the trial progress. While at the same time you continue to hold shares in the company. Now the company has done a successful CR that appears to have been well supported. There is something in that picture that I find incongruous. I smell a rat.
Clarification - Phase I/II UTI/Urosepsis Rapid Infusion Clinical Trial of RECCE®327
SYDNEY Australia, 1 July 2024:Recce Pharmaceuticals Ltd (ASX: RCE,FSE: R9Q) (theCompany), the Company developing a new class of Synthetic Anti-infectives, wishes to clarify the announcement released on 28 June 2024 surrounding the completed Phase I/II UTI/Urosepsis Rapid Infusion Clinical Trial.
The Phase I/II clinical trial was an Open Label, Adaptive Design Evaluation, Crossover Study of the Safety, Pharmacokinetics and Pharmacodynamics of Various RECCE®327 (R327) Intravenous Dose and Infusion Rates.
The primary trial outcomes were to evaluate the safety and tolerability of R327 administered at various infusion rates ranging from 15 to 45 minutes in healthy male and female participants, and to assess the plasma pharmacokinetics of R327 using the same infusion rates. The secondary trial outcomes focused on evaluating the concentration of R327 in urine at various doses and infusion rates, as well as examining theex vivopharmacodynamics, specifically the minimum inhibitory concentration (MIC), of urine and blood samples from participants. Trial outcomes were successfully achieved
Participants in the trial received R327 via intravenous administration across a range of infusion times, with the duration of infusion and dose varying across the cohorts. The trial included a total of 25 participants, as stated in the announcement released on June 28, 2024. These participants were divided into five cohorts, each receiving R327 at different infusion times and doses. A control group was not used. The subject demographics consisted of healthy males and females aged 18-65.
Cohort 1 (2,500mg, 45-min infusion rate)–nine trial subjects
Cohort 2 (3,000mg, 30-min infusion rate)–four trial subjects
Cohort 3 (3,000mg, 15-min infusion rate)–two trial subjects
Cohort 4 (3,000mg, 20-min infusion rate)–four trial subjects
Cohort 5 (4,000mg, 20-min infusion rate)–six trial subjects
An independent data review has been conducted and made the positive safety and efficacy conclusions stated in the announcement released 28thJune 2024. A comprehensive data review will be conducted with results to be made available to the Company and expected to be in line with findings to date.
(20min delay)