Gene Signal has reported the publication of interim results from a phase II study suggesting that the antisense oligonucleotide GS-101 is safe and effective at inhibiting and regressing corneal neovascularisation.
The aim of the randomised, double-blind, multicenter phase II clinical study was to test the efficacy and tolerability of GS-101, an antisense oligonucleotide against insulin receptor substrate-1 (IRS-1), versus placebo, against progressive corneal neovascularisation (excessive or harmful angiogenesis).
The treatment with GS-101 was generally well tolerated, with no associated serious side effects. At 86µg/day GS-101 eye drops produced a significant inhibition and regression of corneal neovascularisation.
However, the low dose tended to stabilise growth compared to placebo, where corneal neovascularisation progressed in all patients in the 3 month period. The high dose of GS-101 was found to have no additional benefit.
Reportedly, the company is now conducting an international phase III trial with GS-101 for the prevention of pathologic corneal neovascularisation and thereby corneal graft rejection. GS-101 has been granted Orphan Drug status in Europe.
Eric Viaud, CEO of Gene Signal, said: “The publication of these positive phase II results for GS-101 is a major milestone for Gene Signal. As a novel approach to the management of ophthalmic angiogenesis, we are keen to provide rigorous scientific backup to support our ongoing clinical development program.
We also recently published data in the Journal of Pharmacology and Experimental Therapeutics confirming that GS-101 prevents in vivo expression of IRS-1, a protein associated with new blood vessel formation (angiogenesis), and we intend to present additional data on GS-101 at various scientific forums in the near future.”