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ESBATech AG has launched a study into the safety, tolerability and pharmacokinetic profile of its lead antibody fragment ESBA105 when delivered topically via eye drops in healthy volunteers.
The phase I study is being conducted as a single and repeated dose escalation study in Switzerland.
ESBA105 is a single-chain antibody fragment directed against TNFa. It is being developed initially for ophthalmic indications.
In previously reported in vivo, preclinical studies, ESBA105 achieved high therapeutic concentrations in all ocular tissues, when given topically via eye drops. Therapeutic concentrations of ESBA105 were observed throughout the front and the back segments of the eye, the latter including the vitreous humor, retina and choroid.
Peter Lichtlen, of ESBATech AG, said: “ESBA105 shows an entirely novel and unique intraocular distribution pattern upon topical administration to the eye.
“Therapeutic levels are reached in both the aqueous and vitreous humor after only a couple of hours following initiation of treatment.
“Our in vivo, preclinical studies have shown that ESBA105 has a prolonged half-life of 25 hours in the vitreous. Thus, the vitreous acts as a natural depot compartment for ESBA105, allowing for highly attractive maintenance dosing regimens.
“TNFa is a rapidly emerging target in ophthalmology and ESBA105 has the potential to be a significant advancement in anti-inflammatory ophthalmic medicine.”
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