QR-01 is a product that not only introduces a novel active compound for this disorder, but also employs a unique formulation. The formulation is a proprietary liquid at administration but becomes semi-solid at mouth temperature.
In addition, the active molecule is synthesized by a novel proprietary method of synthesis.
The Company has currently successfully completed a 14-day toxicology study in hamsters and test of effectiveness in a Beagle Dog Study.
In the 14-days toxicology study, all animals exhibited high tolerance to the drug, with no adverse reactions or irritation at the buccal application site. No significant side effects were observed and more importantly, the necroscopic cross examination showed no changes in tissues. The successful completion of this study marks an important milestone for Orocidin, providing the foundation for the upcoming pivotal 8-week toxicity study.
The Company launched an extended eight-week study to further confirm its safety.
The Beagle Dog Study is the first study that shows Orocidin’s drug, QR-01, having a direct effect on periodontitis diagnosed in beagle dogs.
The 13-day small efficacy study was conducted on beagle dogs with clinically confirmed periodontitis.
The dogs demonstrated consistent improvements across key clinical endpoints, including the Gingival Index, the Plaque Index and overall periodontal Disease.
These results support the clinical relevance of QR-01, as periodontitis in dogs is a well-established model for the human condition.
Moreover, QR-01 was well tolerated, with no adverse side effects reported throughout the treatment period.
Pre-clinical efficiacy study in Wistar rats withperiodonitits (ongoing).
Initiate 8-Week toxicity study in hamsters.
Initiate pilot efficacy study
in patients.