First patient dosed in AXT107 clinical trial for DME
The first patient has been dosed in a phase 1/2a clinical trial of AXT107 to evaluate the safety and bioactivity of the therapy in patients with diabetic macular edema, according to a press release from AsclepiX Therapeutics.
CONGO, an open-label, dose-escalating, 48-week trial, will evaluate a single intravitreal injection of AXT107 at a low dose of 0.1 mg, a mid-dose of 0.25 mg or a high dose of 0.5 mg in approximately 18 patients.
An investigational new drug application for AXT107 was cleared by the FDA in December for the treatment of retinal diseases such as DME, wet age-related macular degeneration and macular edema following retinal vein occlusion.
AXT107 inhibits VEGF-A and VEGF-C and activates Tie2, the release said.
“We are hopeful that AXT107’s unique mechanisms of action, as a peptide and intravitreal self-forming gel depot, will improve outcomes and decrease patient and caregiver burden for our DME patients,” Jeffrey Heier, MD, principal investigator and director of the vitreoretinal service and director of retina research at Ophthalmic Consultants of Boston, said in the release.
AXT107 has the potential for once-per-year dosing, the release said.
Perspective
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It is thrilling to be the first to inject a novel product in a human. I am fortunate to have an expert site staff and a willing patient who was enthusiastic about being first to receive this product. This new therapy has the potential to improve safety through its novel mechanism of action and potentially greatly extend the duration of injectable therapy through its novel delivery technology. Of course, we need to see this bear out in human trials.
A lowered treatment burden depends on the clinical effect and how durable the therapy actually is. We will have to see what the response is as the dose escalates in this phase 1 study. It is difficult to predict at this point. It will be fascinating to follow these patients out and see what the open-label durability is. Although this is a small open-label series, it will certainly be encouraging if durability of a single shot is several months or longer.
AXT107 holds great potential in the injectable space.
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