Sulfagenix’s initial product, SG1002, has been demonstrated in clinically relevant cardiovascular disease models* to:
• Decrease infarct size
• Improve cardiac function
• Increase angiogenesis
• Down-regulate oxidative stress
• Decrease inflammation
Heart Failure Clinical Development
Safety as well as proof of concept studies have been completed in humans and animal models. More rigorous human studies are planned to validate the proof of concept evidence and evaluate functional outcomes.
Sulfagenix Australia is conducting a double blind, placebo controlled dose escalation Phase I study of SG1002 in normal volunteers and heart failure patients (http://www.clinicaltrials.gov/ct2/show/NCT01989208). After safety has been established and an optimal dose identified, a Phase II study will be conducted with endpoints of echo strain, 6 minute walk distance and quality of life questionnaires added to the biomarker endpoints being utilized in the Phase I study.
Phase I Dose Ascending Clinical Trial - COMPLETED
8 normal, randomized 3:1
8 CHF patients, randomized 3:1
200, 400, 800 mg BID for 7 days each
Primary endpoints: safety, H2S, GSSH, BNP blood levels
Phase II Clinical Trial - PLANNED
50 CHF patients, randomized 1:1
Placebo or optimal dose SG1002 BID for 90 days
Primary endpoints: safety, H2S GSSH, BNP blood levels
Secondary endpoints: Echocardiography, 6MW, QoL
*Polhemus DJ, Kondo K, Bhushan S, Bir SC, Kevil CG, Murohara T, Lefer DJ, Calvert JW. Hydrogen Sulfide Attenuates Cardiac Dysfunction After Heart Failure via Induction of Angiogenesis. Circ Heart Fail. 2013 Sep 1;6(5):1077-86.