Nanoscope Therapeutics has concluded subject enrolment in the Phase II STARLIGHT clinical trial of its gene therapy, MCO-010, for vision restoration in blind patients with Stargardt disease.
The open-label trial enrolled six participants who had advanced vision loss because of a clinical or genetic diagnosis of Stargardt disease.
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All subjects in the trial were given a single intravitreal 1.2E11gc/eye dose of MCO-010.
The same dosage of the therapy is analysed in a Phase IIb retinitis pigmentosa (RP) trial of the company.
Nanoscope anticipates six-month findings from the STARLIGHT trial in the first half of next year.
A lead asset of the company, MCO-010 is an ambient-light activatable Multi-Characteristic Opsin (MCO) optogenetic therapy.
The therapy leverages an AAV2 vector for delivering MCO genes into retinal cells to provide vision in various colour environments.
MCO-010 is given as a single intravitreal injection in the in-office setting, without requiring any other interventions or devices.
The US Food and Drug Administration granted orphan drug designations to the therapy for RP and Stargardt disease.
Nanoscope CEO Sulagna Bhattacharya said: “We are excited by the therapeutic potential of MCO-010, supported by robust data from previous preclinical and clinical studies.
“Completing the quick two-month enrolment of this Phase II trial, which will evaluate the safety and effects of a single intravitreal injection of MCO-010, brings us another major step forward in developing this novel therapy with broad therapeutic application.”
A blinding condition, Stargardt disease impacts adults and children. It is the most prevalent macular dystrophy and has no validated therapy.
In July this year, the company dosed the first subject in the Phase II trial of MCO-010 for Stargardt disease treatment.
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