ONL Therapeutics to Report Clinical Data on ONL1204 in Podium Presentation at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting


Presentation will review the results of ONL’s Phase 1 study of ONL1204 Ophthalmic Solution in patients with Macula-Off Rhegmatogenous Retinal Detachment

Preclinical data in models of inherited retinal degeneration and age-related macular degeneration to be shared in poster presentations

ANN ARBOR, Mich., April 11, 2023 (GLOBE NEWSWIRE) -- ONL Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel therapies for protecting the vision of patients with retinal disease, today announced that the company will deliver a podium presentation reviewing the results from a Phase 1 study to evaluate the safety of ONL1204 ophthalmic solution for the treatment of patients with macula-off rhegmatogenous retinal detachment (RRD) at the upcoming annual meeting of the Association for Research in Vision and Ophthalmology (ARVO). The ARVO Annual Meeting will take place April 23-27, 2023, at the Ernest N. Morial Convention Center in New Orleans, LA.

ONL1204 Ophthalmic Solution is a first-in-class small molecule Fas inhibitor designed as a neuroprotectant for key retinal cells. ONL intends to initiate a Phase 2 clinical study of ONL1204 Ophthalmic Solution in patients suffering from macula-off RRD at sites in the U.S. in the second quarter of 2023.

Details of the podium presentation are as follows:

Title:Safety and Tolerability of Intravitreal ONL1204 in Patients with Macula-off Rhegmatogenous Retinal Detachment
Presenter:Matthew Simunovic, MB BChir PhD FRANZCO
Professor of Ophthalmology & Visual Science
Faculty of Medicine and Health
Clinical Ophthalmology and Eye Health
Save Sight Institute
Time/Date:10:15 a.m. Central Daylight Time on Tuesday, April 25, 2023
Location:Room 353-355
  

The company will also present preclinical data on the protective effect of pharmacological Fas inhibition from models of inherited retinal degeneration and age-related macular degeneration in poster presentations.

Details of the poster presentations are as follows:

Session:#68 Age-related Macular Degeneration (AMD) New Drugs, Delivery Systems and Mechanisms of Action 2
Title:Fas Inhibition Preserves Retinal and Retinal Pigment Epithelium (RPE) Phenotype in a Chronic Smoke Exposure Model of AMD
First Author:Marisol Cano, PhD, Research Associate, Wilmer Eye Institute – Johns Hopkins Medicine
Time/Date:3:45 p.m. – 5:30 p.m. Central Daylight Time on Sunday, April 23, 2023
Location:Exhibit hall - C0287
  
Session:#88 Inherited Retinal Degeneration
Title:Protective Effect of Pharmacological Fas Inhibition in Two Mouse Models of Inherited Retinal Degeneration
First Author:Jingyu Yao, PhD, Research Lab Specialist Senior, Department of Ophthalmology and Visual Sciences, University of Michigan
Time/Date:11:30 a.m. – 1:15 p.m. Central Daylight Time on Monday, April 24, 2023
Location:Exhibit hall - B0196

About ARVO
The Association for Research in Vision and Ophthalmology (ARVO) is the largest eye and vision research organization in the world. Members include approximately 10,000 eye and vision researchers from over 75 countries. ARVO advances research worldwide into understanding the visual system and preventing, treating and curing its disorders. Learn more at ARVO.org.

About ONL1204 Ophthalmic Solution
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. 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 United States Food and Drug Administration (FDA). The company 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), both being conducted at sites in Australia and New Zealand. Preclinical work is ongoing to enable clinical trials in other disease indications, including inherited retinal degeneration (IRD; also known as retinitis pigmentosa).

About ONL Therapeutics

ONL Therapeutics (ONL) is a clinical-stage biopharmaceutical company committed to developing first-in-class therapeutics to protect and improve the vision of patients with retinal disease. By advancing a breakthrough technology designed to protect key retinal cells from Fas-mediated cell death, ONL is pioneering a new approach to preserving vision. ONL is developing a platform of products for use in a wide range of blinding diseases, including retinal detachment, glaucoma, AMD and IRD.

For more information about ONL Therapeutics, please visit www.onltherapeutics.com.

 

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