Phase I Clinical Trial
Sulfagenix Australia has recently completed a Phase I study in 15 healthy subjects (n = 7) and heart failure patients (n = 8) (http://www.clinicaltrials.gov/ct2/show/NCT01989208). Administration of SG1002 resulted in increased H2 S levels in healthy subjects. We also observed increased H2 S levels in HF subjects following 400 mg SG1002. Nitrite, a metabolite of NO, was increased in both healthy and HF patients receiving 400 mg and 800 mg SG1002. HF subjects treated with SG1002 displayed stable drug levels over the course of the trial. SG1002 was safe and well tolerated at all doses in both healthy and HF subjects. These data suggest that SG1002 increases blood H2 S levels and circulating NO bioavailability. The finding that SG1002 attenuates increases in BNP in HF patients suggests that this novel agent warrants further study in a larger clinical study.
Phase II Clinical Trial
Based on safety identified in the Phase I study and achieving reasonable blood levels of hydrogen sulfide, the optimal dose along with placebo, will be used for continued evaluation in a Phase II study. The Phase II study will include heart disease patients randomly assigned to the SG1002 or placebo. The study will be carried out to demonstrate safety of chronic (3 months) drug administration and the ability to overcome deficits found in heart disease patients, including deficits in hydrogen sulfide anin markers of oxidative stress or heart disease. In addition to validating endpoints in the Phase I study, the Phase II study will also evaluate functional outcomes including quality of life parameters in patients with heart failure.