Fibrotech, an Australian biopharmaceutical company developing a new class of drugs to prevent a massive health burden associated with fibrosis, today announced that its lead anti-fibrotic compound FT011 has successfully completed a Phase Ia trial in healthy volunteers demonstrating safety and tolerability up to doses of 1000mg. At the same time Fibrotech announced the commencement of a Phase Ib trial involving patients with diabetic nephropathy associated with Type 1 or Type 2 diabetes. Both trials have been and will be conducted in Australia.
The Phase Ia study was a double blind, randomised, placebo-controlled, dose-escalating study of the safety, tolerability, food effect and pharmacokinetics of single and repeat doses of FT011 administered orally to healthy volunteers. There were three stages in the study. In the first stage, 40 healthy volunteers received single doses of FT011 (10, 30, 100, 300 and 1000 mg). In the second stage, 8 heathy volunteers were given a 100mg dose under fed rather than fasting conditions to examine food effects. In the third and final stage healthy volunteers were administered daily doses of FT011 (250 or 500mg) for 14 days. All stages of the study demonstrated the safety and tolerability of FT011 with a once daily pharmacokinetic profile and no food effects or any observed adverse events.
The Phase Ib study about to begin will be a double blind, randomised, placebo-controlled, dose-escalating, multiple dose study involving 24 healthy male volunteers and up to 16 patients with Type 1 or Type 2 diabetes-associated nephropathy. As well as confirming the safety and tolerability of FT011 this second Phase I trial will also look for key biomarkers in the patient group.
Prof. Darren Kelly, CEO of Fibrotech commented:
"These Phase Ia results confirm our preclinical findings that FT011 is well tolerated and we keenly await the results of the Phase Ib trial. Patient recruitment has already begun and we expect first dosing to begin tomorrow, on March 11. 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."
Source: Fibrotech Therapeutics Pty Ltd