Fibrotech completes phase Ia trial, moves to 1b

Melbourne’s Fibrotech Therapeutics has completed a phase Ia trial of lead antifibrotic compound FT011 in healthy volunteers and commenced a phase Ib trial in patients with diabetic nephropathy.

The phase Ia trial has confirmed the safety and tolerability up to doses of 1000 mg. During the double-blind, randomised, placebo-controlled, dose-escalating study, 40 healthy volunteers were given doses between 10 and 1000 mg.

During the second stage, eight volunteers were given a 100 mg dose under fed rather than fasting conditions, and in the final stage, volunteers were given daily 250 or 500 mg doses for 14 days.

No significant adverse events were observed at any stage, and FT011 was found to be well tolerated with a once daily pharmacokinetic profile.

Dosing in the phase Ib trial commences today. It will involve 24 healthy volunteers and up to 16 patients with Type 1 or Type 2 diabetes-associated nephropathy. The trial will seek to confirm safety and tolerability, and will also look for key biomarkers in the patient group.

“These Phase Ia results confirm our preclinical findings that FT011 is well tolerated and we keenly await the results of the Phase Ib trial,” Fibrotech CEO Professor Darren Kelly commented.

“It is very exciting to be making such progress in developing a compound with real promise to benefit patients with diabetic nephropathy and delay the progression of this disease.”

Fibrotech recently secured patents in the US and Canada covering FT011 and the other candidates in the company’s antifibrotic portfolio.