RE: RNS Timeline4 May 2020 19:56
- 24/10/2019; U.S. Army-funded research project to Evaluate Iclaprim. The Company has signed an agreement with the Walter Reed Army Institute of Research (WRAIR) to conduct pre-clinical testing to evaluate novel combinations with iclaprim to improve safety and efficacy administered by a novel enhanced aerosol technology.
The aerosol technology allows delivery of antibiotics painlessly and rapidly into skin and soft tissue with low-pressure and focused delivery. The research is being funded through a grant from the U.S. Department of Defense - Congressionally Directed Military Infectious Diseases Research Program to evaluate the potential of using such a drug-device combination for wound care and to prevent and treat wound infections on the battlefield. The work will be led by Dr. Daniel Zurawski,
David Huang, M.D., Ph.D., Chief Medical Officer of Motif Bio, said: "When a wound becomes infected, it is critical to provide safe and effective treatment as fast as possible. The data generated from Dr. Zurawski's research will be important in understanding whether iclaprim delivered locally could play a role in treating battlefield wound infections.”
In March 2020 a paper was released that compared PHASE 3 REVIVE of the safety and efficacy of Iclaprim vs Vancomycin for treatment of acute bacterial skin and skin structure infections.
Results: Results. In REVIVE-1, ECR was 83.5?% with iclaprim versus 79.7?% with vancomycin (treatment difference 3.77%, 95?%?CI -4.50%, 12.04%). In REVIVE-2, ECR was 82.7?% with iclaprim versus 76.3?% with vancomycin (treatment difference 6.38%, 95?%?CI -3.35%, 16.12%). In the pooled dataset, iclaprim had similar ECR rates compared with vancomycin among wound infection patients (83.2?% vs 78.2?%) with a treatment difference of 5.01?% (95?% CI -1.29%, 11.32%). The safety profile was similar in iclaprim- and vancomycin-treated patients, except for a higher incidence of diarrhea with vancomycin (n=17) compared with iclaprim (n=6) and fatigue with iclaprim (n=17) compared with vancomycin (n=8).
Conclusion. Based on early clinical response, iclaprim achieved non-inferiority to vancomycin with a similar safety profile in patients with wound infections suspected or confirmed as caused by Gram-positive pathogens. Iclaprim may be a valuable treatment option for wound infections.