Regional EuroTimes
Date Posted 16/05/2009
Complement factor inhibition a potential new treatment strategy in AMD
Complement factor inhibition a potential new treatment strategy in AMD
Preliminary results of a phase I study indicate that intravitreal administration of ARC1905 (Opththotech), a complement factor 5 (C5) inhibitor, is safe and may therefore represent a promising new strategy for the treatment of neovascular Age-Related Macular Degeneration (AMD), Jordi Mones MD, Spain, told the 9th EURETINA Congress.
“While anti-VEGF agents are showing great success there is still room for improvement. One promising new treatment is blocking complement factor 5a with C5 aptamer.
There is growing evidence that AMD is an inflammatory disease, Dr Mones noted. Recent research has shown that polymorphisms in the genes for complement-regulating proteins may increase the likelihood of AMD by over seven-fold. And in the eyes of patients with glomerulonephritis, an inflammatory condition which can led to renal failure, there are drusen which are identical to those in AMD, he added.
The new agent, ARC1905, is a potent and selective inhibitor of factor C5 of the complement cascade. However, it does not influence the formation of other complement components such as C3b, which are important in host defense mechanisms.
In the ongoing dosage finding part of the two-part phase I trial, patients are receiving receive three monthly intravitreal administrations of ARC1905 at one of four doses, 0.03 mg, 0.3 mg, 1.0 mg, and 3.0 mg in combination with monthly ranibizumab 0.5 mg. As of now 17 patients receiving the lower dosages of 0.03mg and 0.3 mg and one patient receiving 1 mg have been followed for up to four weeks and none have shown signs of dose-limiting toxicity.
In the second, parallel group part of the phase I study, the investigators will chose two ARC1905 dose levels based on the results of Part 1 of the study. Patients will receive three monthly intravitreal administrations of ARC1905 in varying regimens with ranibizumab 0.5 mg.
“Initial results of a phase I study investigating C5 inhibition in combination with an anti-VEGF agent revealed no signs of acute toxicity. These safety results to date, combined with preclinical and genetic linkage studies implicating complement-mediated inflammation in AMD, suggest that continued development of an anti- C5 strategy may hold promise for future AMD therapy,” Dr Mones added.
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