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news.Concert Pharmaceuticals has presented Phase1 clinical study results of CTP-499 used to treat diabetic nephropathy.
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CTP-499 is an analog of 1-((S)-5-hydroxyhexyl)-3,7-dimethylxanthine (HDX), an active metabolite of pentoxifylline and has a pleiotropic mechanism of action including angiotensin converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (ARBs).
The double-blind,placebo-controlled, randomized, single ascending-dose study has enrolled 38 healthy volunteers.
The primary aim of the study was to evaluate the safety, tolerability and pharmacokinetics of a controlled-release formulation of CTP-499 given as a single dose to four successive cohorts of 8 healthy subjects each (600 mg, 1200 mg, 1800 mg, and 2400 mg).
The results showed that a controlled-release formulation of CTP-499 was well-tolerated at single doses up to and including 1800 mg.
Concert Pharmaceuticals CMO James Shipley said they believe that the properties of CTP-499 and its metabolites may result in favorable biologic activity as an anti-inflammatory, anti-oxidant and anti-fibrotic agent in chronic kidney disease.
"We look forward to advance CTP-499 into a proof-of-concept study in patients with type 2 diabetes and renal impairment," Shipley said.
The company palns to begin a Phase 2 clinical trial of CTP-499 in patients with diabetic nephropathy during the first half of 2012.