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news.Isarna Therapeutics has initiated a Phase I clinical trial with ISTH0036, an antisense oligonucleotide selectively targeting TGF-β2, to treat advanced glaucoma.
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Around 24-30 patients will be enrolled in the first-in-human trial, which will be conducted at the University Hospitals of Mainz and Tuebingen in Germany.
The trial will evaluate the safety and long-term tolerability of ISTH0036 in patients with advanced glaucoma undergoing filtration surgery (trabeculectomy) due to uncontrollable elevated intraocular pressure (IOP).
In the trial patients will be treated with escalating doses of ISTH0036 and in addition to the safety, patients will be monitored for intraocular pressure and visual field preservation.
Isarna Clinical Development head professor Eugen Leo said: "Glaucoma is the leading cause of irreversible blindness in the world, and ISTH0036 with its expected three-directional activity, which includes blocking TGF-ß2-mediated trabecular meshwork alteration, and inhibiting both direct optic nerve toxicity and scarring post trabeculectomy, has the potential to substantially alter the course of this disease and protect the patient’s vision.
"Notably, ISTH0036 is currently the sole compound in clinical development worldwide that directly targets the core driver of the pathophysiology of glaucoma: TGF-ß2."
The company said that TGF-ß has been shown to directly cause increased intraocular pressure leading to decreased aqueous humor outflow and has been linked to direct optic nerve toxicity.
Isarna Therapeutics CEO Dr Philippe Calais said: "The start of our first Phase I trial in advanced glaucoma is a major corporate milestone, one that we have achieved two years after starting this program thanks to an outstanding and expedited preclinical program."