Iveric bio the latest to be hit by COVID-19 as it delays a key trial

Iveric Bio has been forced to hit the pause button for a pivotal test on its leading drug Zimura as COVID-19 continues to back up clinical trials.

The biotech said it was now having to delay enrollment in the second pivotal study for its investigational therapy Zimura, which was slated to be trialed in patients with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).

The New York-based biotech said this was “for the safety and well-being of our elderly patients and participating physicians and their staffs” after the U.S. declared COVID-19 an official emergency. The the aim now is to employ social distancing to try to curb the spread of the disease, especially among the elderly/those with underlying conditions who appear to be at a higher risk of severe forms of the disease.

This follows Provention Bio and Addex, both of which have also had to pause their respective studies due to the ongoing pandemic.

“In light of the COVID-19 pandemic and out of an abundance of caution for the safety and well-being of our elderly patients and participating physicians and their staffs, we have decided to delay the initiation of enrollment in our second pivotal trial of Zimura in geographic atrophy secondary to dry AMD, the ISEE2008 trial, which was on track to begin this month,” said CEO Glenn Sblendorio.

“It is critically important that we heed the warnings from the U.S. Centers for Disease Control, World Health Organization and national, state and local governments during this time of uncertainty. We will continue to closely monitor the situation in the United States and abroad to determine when enrollment should begin.”

“Our first priority is to ensure the best interest of our patients, caregivers, and physicians,” added Chief Medical Officer Kourous Rezaei, M.D. “We want to thank clinical investigators and their teams for their enthusiasm and support in completing the activities necessary to begin enrolling patients at a number of clinical sites, including identification of potential patients for this trial. We will continue our efforts to prepare additional clinical sites, so that we can begin enrolling patients expeditiously, once the COVID-19 threat dissipates.”

This will be a blow to the microcap, which last fall posted positive data from Zimura (avacincaptad pegol) that saw the complement factor C5 inhibitor hit its primary endpoint in a phase 2b study by reducing the rate of GA growth in patients with dry AMD.

Iveric, known as Ophthotech before its recent change-up, turned itself into a gene therapy biotech (what everyone seems to be doing when something in the pipeline goes wrong) last year.

The rebranding followed a period in which the biotech responded to a phase 3 setback by striking deals for retinal disease gene therapies.

The company was laid low in late 2016 by the failure of two phase 3 clinical trials of anti-platelet-derived growth factor Fovista in wet AMD.

That led Ophthotech to weigh strategic alternatives before deciding to apply its ophthalmic drug development expertise to the advancement of a portfolio of in-licensed gene therapies.

Iveric’s gene therapy pipeline is led by two preclinical assets, IC-100 and IC-200, that are designed to treat rhodopsin-mediated autosomal dominant retinitis pigmentosa and Best disease. The biotech secured rights to the programs through deals with the University of Florida Research Foundation and the University of Pennsylvania and plans to enter the clinic in 2020 and 2021.

But, while Iveric sees gene therapies as its future, its clinical pipeline remains centered on Zimura. That now hangs in the balance as the biotech, along with everyone, else, tries to wait out the COVID-19 spread.