Iveric Bio to Present Zimura GATHER2 Enrollment and Retention Updates and New GATHER1 Post-Hoc Analyses
Iveric bio announced that today at the company’s Virtual Symposium for Investors and Analysts, Arshad M. Khanani, MD, MA, of Sierra Eye Associates, and Chairman of the GATHER2 Steering Committee, will discuss an accelerated enrollment timeline and patient retention, including injection fidelity, for GATHER2, the company’s pivotal clinical trial of Zimura (avacincaptad pegol) in development for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
The company expects to complete enrollment in GATHER2 in late July of this year. Based on this timeline, Iveric bio expects topline GATHER2 data to be available in the second half of 2022, approximately 1 year after the enrollment of the last patient plus the time needed for database lock and analysis. The company also announced that GATHER2 is exceeding patient retention expectations. The company is targeting patient retention for the trial, as measured by 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.
“Since the initiation of GATHER2, Iveric Bio has implemented a patient centric strategy with multiple initiatives to tackle the many challenges that the COVID-19 pandemic brought to conducting clinical trials,” Dr. Khanani said in a company news release. “It is exciting to be a part of a clinical trial that is exceeding enrollment and retention targets and timelines in the midst of a global pandemic. I believe that the positive results from GATHER1, including the early and continuous treatment effect demonstrated, is a key motivator for the recruitment and retention in the GATHER2 clinical trial.”
“We are thrilled to have world leading retinal specialists participate in our symposium and to share the new post-hoc analyses of GATHER1 and the progress of GATHER2,” stated Dhaval Desai, PharmD, Chief Development Officer of Iveric Bio. “Thus far we have seen an injection fidelity rate well above our target goal of greater than 90% and ahead of our expectations. We consider 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. We continue to focus as much on retention as recruitment, not only to protect the integrity of our data, but also to potentially demonstrate the early and continuous treatment effect observed in GATHER1.”
Iveric bio also announced that at today’s event, Vas Sadda, MD, of Doheny Eye Institute at UCLA, will present new post-hoc analyses from the GATHER1 clinical trial on progression of drusen and nascent GA (iRORA*/cRORA**), which are earlier forms of dry AMD, in patients treated with Zimura 2 mg as compared to patients in the sham group. The accompanying graphs illustrate the data that Dr. Sadda will discuss today.
Dr. Sadda stated, “I am excited to present these encouraging data. Dry AMD is the most common cause of blindness in the US, but we have no approved treatments for this devastating disease. Some drugs, including Zimura, are being studied to decrease the rate of growth of geographic atrophy, which is very important. However, the significance of these post-hoc analyses suggest that Zimura may have the potential to impact the disease even before atrophy occurs. Given the compelling results, I believe prospective, randomized studies with Zimura on patients with earlier stages of dry AMD are warranted.”
Pravin Dugel, MD, President of Iveric Bio, stated, “In the GATHER1 post-hoc analyses, we reported decreased conversion of iRORA to cRORA and a decreased conversion of drusen to iRORA or cRORA. Both rates showed an increasing effect over time, consistent with Zimura’s effect on geographic atrophy in GATHER1. While the former shows that Zimura may have a therapeutic benefit in earlier stages of geographic atrophy, the latter suggests that Zimura may have the potential to prevent progression to geographic atrophy altogether in patients with drusen. These post-hoc analyses should be considered hypothesis seeking. Nonetheless, if these results are substantiated with prospective, randomized studies, the potentially sight-saving impact of Zimura on millions of high-risk patients could be a massive leap forward in treating this disease. Our intent is to study Zimura in earlier stages of dry AMD.”
“The impressive data presented today are consistent with our stated goal to build a franchise to treat all stages of AMD, with the expansion of Zimura’s footprint and the continued development of our HtrA-1 inhibitor, IC-500,” stated Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio.
Webcast Information
A live webcast of the event will be available today, June 18, 2021 from 10 am to 12 pm ET under the “Events & Presentations” in the Investors section of the Iveric Bio website at https://investors.ivericbio.com. A replay of the webcast will be posted on Iveric Bio’s website following the presentation and available for at least 30 days.