Frontera Therapeutics, Inc., a Sino-US biopharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase II clinical study for its investigational drug FT-003. This recombinant adeno-associated virus (rAAV) gene therapy is designed for the treatment of neovascular age-related macular degeneration (nAMD).
Mechanism of Action and Preclinical Data
FT-003 boasts a well-defined mechanism of action. Preclinical data demonstrates that FT-003 can efficiently transfect multiple layers of retinal cells following injection into the fundus. This prompts the cells to express and secrete humanized recombinant fusion proteins similar to the aflibercept sequence, which inhibits endothelial cell division and proliferation, reduces vascular permeability, and offers comprehensive therapeutic functions.
Clinical Progress and Efficacy
FT-003 is anticipated to treat nAMD and diabetic macular edema (DME) patients with a single injection, promising long-term effectiveness. In China, FT-003 has completed Phase I clinical studies for nAMD and DME, with Phase II recruitment currently in progress. Preliminary results from the Phase I study confirmed the safety and efficacy of FT-003, showing significant improvements in vision and retinal structure in patients with nAMD and DME. Additionally, the demand for anti-VEGF treatment was reduced by over 80%, substantially lessening the treatment burden for patients.-Fineline Info & Tech
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