US-based clinical-stage biopharmaceutical company SciFluor Life Sciences has initiated both Phase I/II trials of SF0166 to treat diabetic macular edema (DME) and age-related macular degeneration (wet-AMD).
SF0166 has been developed as a potent and selective, small molecule inhibitor of integrin αvβ3 with balanced physiochemical properties to allow it to be distributed to the retina in high concentrations after being topically administered to the eye.
The Phase I/II SF0166-C-001 clinical study is being conducted as a multi-centre, randomised trial intended to determine the safety and preliminary efficacy of SF0166 to treat patients with DME.
The company is also conducting a separate multi-centre, randomised, Phase I/II trial of SF0166 for wet-AMD to determine the safety and tolerability data, as well as note the changes in retinal thickness and visual acuity.
Each of the trials will involve two dosage groups comprising 20 patients.
SciFluor vice-president and general manager Scott Edwards said: “We are pleased to have initiated clinical studies of SF0166 for the treatment of DME and wet-AMD and look forward to generating the clinical data required to advance this potential new therapy.
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“The two ongoing Phase I/II studies will provide initial assessments of the safety, tolerability and preliminary efficacy of SF0166 in patients to guide further clinical development.”
Pre-clinical assays have exhibited SF0166 distributing to the back of the eye in therapeutically effective amounts.