- Recce Pharmaceuticals (RCE) announces “positive” results from its completed phase one study of anti-infective R327
- The trial doses R327 from 50mg to 6000mg and marks the first-in-human study to display safe and well-tolerated treatment with no adverse reactions
- Eighty subjects were randomised into eight single-dose cohorts, with 60 subjects receiving R327 over a one-hour infusion, while 20 received placebo
- Concentration rates of R327 in the urine are twenty-onefold higher than in the plasma, with the primary route of excretion exiting through the kidney
- Shares in RCE are up 14.2 per cent, trading at 76.5 cents at midday AEST
Recce Pharmaceuticals (RCE) has announced “positive” results from its completed phase one study of R327 as an intravenous infusion formulation in 80 healthy male subjects.
The results showed a significant dose-dependent concentration of R327 in both the urine and the plasma, highlighting the potential for R327 to become a viable treatment for sepsis and mild to moderate urinary tract infections (UTIs).
The trial utilised ascending doses from 50 to 6000 milligrams and was randomised and placebo-controlled, representing the first-in-human study to display safe and well-tolerated characteristics with no adverse reactions.
A total of 80 subjects were randomised into eight single-dose cohorts, with 60 subjects receiving R327 over a one-hour infusion, while 20 received placebo.
The company found that concentration rates of R327 in the urine were twenty-onefold higher than in the plasma, with the primary route of excretion exiting through the kidney.
Furthermore, an independent study has also demonstrated that when in human urine, R327 can reduce the number of viable E. coli bacteria by 99.99 per cent in just minutes.
The independently verified results of the company’s anti-infective have achieved all primary study endpoints, and it has met international regulatory standards in data.
“We are pleased to see that, even when administered at doses much higher than the expected therapeutic window, R327 IV does not lead to safety or toxicity issues in healthy subjects,” RCE Non-Executive Director and Medical Monitor of the trial Alan W Dunton said.
“We believe in the potential of R327 to provide a much-needed solution to patients with serious infections and look forward to providing interim proof-of-efficacy data in pre-sepsis patients in H2 2023.”
RCE shares were up 14.2 per cent, trading at 76.5 cents at midday AEST.