Research & Development
Iveric Bio Completes Patient Enrollment of GATHER2 Pivotal Clinical Trial of Zimura Ahead of Schedule
27 July 2021 - - US-based biopharmaceutical company Iveric bio, Inc. (NASDAQ: ISEE) has completed patient enrollment of GATHER2, the company's second pivotal clinical trial of Zimura (avacincaptad pegol) in development for the treatment of geographic atrophy secondary to age-related macular degeneration, ahead of schedule, the company said.

The company expects topline GATHER2 data to be become available during the second half of 2022, approximately one year after the enrollment of the last patient, plus the time needed for database lock and analysis.

In June 2021, the company announced that it is targeting patient retention for the trial, as measured by the injection fidelity rate through month 12, of greater than 90%.

Injection fidelity is calculated by dividing the total number of actual injections by the total number of expected injections based on the number of enrolled patients.

The company considers injection fidelity to be the most important component of patient retention because it reflects the timely administration of the drug into the patient's eye.

The company also announced earlier this month that it received written agreement from the US Food and Drug Administration under a Special Protocol Assessment for the overall design of GATHER2.

The agreement further solidifies the company's plans to file an application with the FDA for marketing approval of Zimura for GA secondary to AMD, if the ongoing GATHER2 clinical trial meets its primary endpoint at 12 months.

Zimura met its pre-specified primary efficacy endpoint at 12 months and reached statistical significance in the previously completed GATHER1 pivotal clinical trial.

In GATHER2, 448 patients were randomized to receive either monthly administration of Zimura 2 mg or sham during the first 12 months of the trial, at which time the primary efficacy analysis of the mean rate of change of GA growth (slope) at 12 months will be performed.

If the 12 month results are positive, the company plans to file an application with the US Food and Drug Administration and the European Medicines Agency for marketing approval of Zimura for GA following receipt of that data.

At month 12, the company plans to re-randomize patients in the Zimura 2 mg arm to receive either monthly or every other month administration of Zimura 2 mg. The final evaluation will take place at month 24.

Zimura (avacincaptad pegol) is an investigational drug product and has not been approved for use anywhere globally.

Zimura is designed to target and inhibit the cleavage of complement protein C5 and the formation of its downstream fragments, C5a and C5b.

By inhibiting the formation of these fragments, Zimura is believed to decrease or slow the chronic inflammation and cell death associated with the retinal aging process by decreasing the formation of membrane attack complex and inflammasome activity, thereby potentially avoiding or slowing the degeneration of retinal pigment epithelial cells.

This potential mechanism is the rationale for Zimura as a potential therapy for geographic atrophy secondary to age-related macular degeneration.

Iveric Bio is focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs.

The company is currently developing both therapeutic product candidates for age-related retinal diseases and gene therapy product candidates for orphan inherited retinal diseases.
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