Genkyotex, the leading developer of NOX inhibitors to treat oxygen-radical mediated diseases, announced today that Phase I studies have demonstrated excellent safety and tolerability following single and multiple oral doses of GKT137831, the first in class NOX 1 and 4 inhibitor. In addition, GKT137831 demonstrated a favourable pharmacokinetic profile in these subjects. Data were presented today at Kidney Week 2012, the annual meeting of the American Society of Nephrology.
GKT137831 was found to be safe and well tolerated when administered orally to a total of 72 healthy adult males, at single doses of up to1800 mg OD, and at multiple doses of up to 900 mg OD for 10 days. No safety signals were identified, and dose limiting toxicities were not reached. Orally administered GKT137831 is rapidly absorbed and has a broadly dose proportional PK over the 10-900 mg dose range. Multiple dose administration does not modify the PK of GKT137831 and there is no accumulation.
"The recently completed multiple ascending dose study has confirmed the excellent safety and pharmacokinetic profile of GKT137831 in healthy subjects, initially shown in the single ascending dose study completed earlier this year. We are now planning the initiation of Phase II clinical studies, including the evaluation of oral GKT137831 in patients with diabetic nephropathy, the lead indication," said Ursula Ney, Chief Executive Officer at Genkyotex.