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ONL Therapeutics completes enrollment in study of first-in-class Fas-inhibitor in patients diagnosed with macula-Off rhegmatogenous retinal detachment


More than 135 patients have been recruited in 4 months for Phase 2 study of a single intravitreal (IVT) injection of ONL1204 ophthalmic solution as an adjunct to standard-of-care surgery.

(Image Credit: AdobeStock/Milos)

(Image Credit: AdobeStock/Milos)

ONL Therapeutics Inc announced the completion of patient enrollment in its Phase 2 clinical trial of ONL1204 Ophthalmic Solution in patients with macula-off rhegmatogenous retinal detachment (RRD).

According to the company, the ongoing Phase 2 clinical trial is a randomly assigned, controlled study designed to assess 135 patients across 3 arms, including 2 treatment groups and a sham group.

In a news release, the company noted the goal of the study is to evaluate the safety and efficacy of a single intravitreal (IVT) injection of ONL1204 as an adjunct to standard-of-care surgical repair in subjects with macula-off RRD at 37 sites across the United States.

The company noted that ONL1204 is a novel, first-in-class small molecule Fas inhibitor designed to protect key retinal cells, including photoreceptors, from cell death that occurs across a range of retinal diseases and conditions. Death of these retinal cells, through both direct and inflammatory signaling pathways, is the root cause of vision loss and the leading cause of blindness.

Moreover, according to the news release, the company’s later-stage clinical development program for ONL1204 currently includes a Phase 2 study in the U.S. for the treatment of macula-off retinal detachment (NCT05730218), a condition for which the compound has been granted orphan drug designation by the FDA.

The company, according to its news release, is also conducting a Phase 1b clinical trial in patients with geographic atrophy (GA) associated with age-related macular degeneration (AMD) (NCT04744662) and a Phase 1b clinical trial in patients with progressing open-angle glaucoma (NCT05160805) at sites in Australia and New Zealand. Preclinical work is ongoing to enable clinical trials in other disease indications, including inherited retinal degeneration.

David Esposito, CEO of ONL Therapeutics, noted in the news release the milestone of completing enrollment of more than 135 patients in this U.S.-based Phase 2 study is a critical milestone as the company continues its efforts to advance ONL1204 for patients suffering from retinal diseases such as RRD.

“We look forward to sharing topline results from this study in the first half of next year and to completing our Phase 1b clinical studies in the chronic indications of geographic atrophy associated with age-related macular degeneration and progressing open-angle glaucoma, both of which are being conducted at sites in Australia and New Zealand,” he added in the news release.

David Zacks, MD, PhD, co-founder and chief scientific officer of ONL Therapeutics, pointed out in the news release the company has been pleased with how quickly its participating clinical sites were able to recruit for the Phase 2 RRD study.

“The level of enthusiasm and partnership from our sites has been tremendous as we work toward our common goal of bringing a novel neuroprotection therapy to patients suffering from RRD,” Zacks said in the news release. “We are extremely grateful to the patients, families and investigators involved for their dedication and commitment to this study.”

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