Recce Pharmaceuticals Ltd, the company behind a new class of synthetic anti-infectives, has announced the successful completion of safe dosing in the first cohort of a Phase I/II clinical trial for urinary tract infections (UTIs). The trial evaluated the company’s drug candidate, R327, at faster infusion rates. The dosing of both male and female subjects was conducted at Scientia Clinical Research, and the results indicate that R327 continues to be safe and well-tolerated.
James Graham, Chief Executive Officer of Recce Pharmaceuticals, expressed his satisfaction with the completion of dosing ahead of schedule, stating that it confirms the company’s progress towards achieving the study’s objectives. R327 demonstrated its safety and tolerability when administered at two faster infusion rates of 2,500mg through intravenous administration. An independent safety committee has reviewed the dosing data from the complete cohort and is expected to recommend continuing the study.
Recce Pharmaceuticals is known for developing a new category of synthetic anti-infectives to address the growing global health concern of antibiotic-resistant superbugs and emerging viral pathogens. The company’s anti-infective pipeline comprises three broad-spectrum, patented, synthetic polymer anti-infectives: RECCE327, RECCE435, and RECCE529.
RECCE327 is being developed as an intravenous and topical therapy to treat serious and potentially life-threatening infections caused by Gram-positive and Gram-negative bacteria, including their superbug forms. The drug candidate has been awarded Qualified Infectious Disease Product designation by the FDA under the Generating Antibiotic Initiatives Now (GAIN) Act, which grants it Fast Track Designation and 10 years of market exclusivity post-approval. RECCE327 has also been included on The Pew Charitable Trusts Global New Antibiotics in Development Pipeline as the only synthetic polymer and sepsis drug candidate under development.
Recce Pharmaceuticals wholly owns its automated manufacturing facility, which supports ongoing clinical trials. The company aims to leverage the unique properties of its technologies to target unmet medical needs and overcome the challenges posed by bacterial and viral mutations. Despite RECCE327’s promising potential, it is important to note that it is not yet approved for use in humans, and further clinical testing is required to evaluate its safety and efficacy.
For additional details regarding the clinical trial, interested parties can refer to anzctr.org.au using the Trial ID ACTRN12623000448640.
In summary, Recce Pharmaceuticals has successfully completed safe dosing in the first cohort of a Phase I/II clinical trial for UTIs. The drug candidate, R327, has been shown to be safe and well-tolerated at faster infusion rates, according to data from male and female subjects. This milestone reinforces the company’s progress towards achieving its study objectives. Recce Pharmaceuticals continues to pursue the development of a new class of synthetic anti-infectives to combat antibiotic-resistant superbugs and emerging viral pathogens.
