Wet AMD trial completes patient enrolment

Opthea (ASX:OPT), a developer of novel biologic therapies for the treatment of eye diseases, has completed patient enrolment in its ongoing phase 1 dose escalation clinical trial of OPT-302 as a novel therapy for wet age-related macular degeneration (wet AMD).

Wet AMD is the leading cause of blindness in the Western world and is caused by the abnormal growth and leakage of vessels at the back of the eye, resulting from the overexpression of the proteins VEGF-C and VEGF-D. OPT-302 blocks the activity of VEGF-C and VEGF-D and thus has the potential to improve patients’ vision.

The phase 1 trial is a first-in-human, open-label, sequential dose escalation study designed to evaluate the safety and clinical activity of intravitreal injections of OPT-302 either in combination with standard of care ranibizumab (Lucentis) or alone as monotherapy for patients with wet AMD. It is being run under an Investigational New Drug (IND) program with the FDA at 14 sites across the US.

The trial enrolled the target 20 patients into four treatment cohorts that included three OPT-302 dose-escalation groups (0.3, 1 or 2 mg) in combination with Lucentis (0.5 mg) and an OPT-302 monotherapy group (2 mg). To date, doses of 0.3 or 1 mg in combination with Lucentis by intravitreal injection have been well tolerated, according to Opthea, with a promising safety profile in both treatment-naive and previously treated patients with wet AMD. This enables patient enrolment into the 2 mg dose cohorts.

With the dose escalation trial fully enrolled, the company expects to complete the 28-day safety assessment period for 2 mg subjects in April, which is a primary objective of the phase 1 study. Additional evaluation of longer-term patient outcomes is expected in the third quarter of 2016, when all of the enrolled subjects have completed dosing on a monthly basis for three months.

“Full enrolment into the phase 1 dose escalation study is an important milestone for Opthea,” said Opthea CEO and Managing Director Dr Megan Baldwin. “Our team and our investigators are excited about the progress of the study and the potential of OPT-302 to address the unmet medical need for wet AMD patients. We look forward to reporting further outcomes from the ongoing phase 1 trial throughout 2016.”

Opthea (ASX:OPT) shares were trading 2.30% lower at $0.425 as of around 1.30 pm on Wednesday.