ONL Therapeutics Announces First Patient Treated in Phase I Study with ONL1204

ONL Therapeutics Announces First Patient Treated in Phase I Study with ONL1204

ONL Therapeutics transformed into a clinical stage biopharmaceutical company with first-in-human study

ANN ARBOR, MI – October 23, 2019

ONL Therapeutics, Inc., a biopharmaceutical company developing novel therapies for protecting the vision of patients with retinal disease, today announced that the first patient has been treated in the company’s First-in-Human trial with its lead drug candidate ONL1204. The study is being conducted in Australia at leading clinical research centers in Sydney and Melbourne. The study will assess four different doses of ONL1204 and is designed to demonstrate safety and tolerability of the investigational drug in patients with a macula-off rhegmatogenous retinal detachment (RRD).

“This is a transformational step for our company with the announcement of our first patient being treated with ONL1204,” commented David Esposito, CEO of ONL Therapeutics. “I want to thank our dedicated team, our investors, and retinal surgeons around the world who have been seeking a therapeutic intervention to support improving the outcome of the current standard of care surgery for macula-off RRD. We look forward to working with retinal specialists to utilize our Fas inhibition platform to protect the vision of patients with retinal disease.”

ONL1204 has been granted orphan drug designation for the treatment of retinal detachment by the United States Food and Drug Administration (FDA). The company is embarking on a Series B round of financing to continue funding its clinical development plans for ONL1204 and expand the development pipeline of its platform of Fas inhibitors for use in a range of retinal disease indications, including glaucoma, age-related macular degeneration (AMD), and inherited retinal degeneration (IRD; also known as retinitis pigmentosa).

The company raised a $3 million convertible note in August of this year to accelerate its clinical development plans. Current investors in the company include Invest Michigan, the University of Michigan’s Investment in New Technology Startups (MINTS) program, the Biosciences Research & Commercialization Center, Novartis, InFocus Capital Partners, ExSight Ventures, Hestia Investments, and the Capital Community Angels.

“We are excited to be the first clinical research site in the world to administer ONL1204, a first-in-class therapy designed to help patients with a macula-off rhegmatogenous retinal detachment,” said Matthew Simunovic, MB BChir PhD FRANZCO lead investigator at the Sydney Eye Hospital in Sydney, Australia. The company anticipates the study will take about 12 months to complete. The scientific findings gathered throughout the study will help determine future development plans for the company’s portfolio of products addressing a wide range of retinal diseases.

About ONL1204

ONL1204 is a novel, first-in-class small molecule Fas inhibitor designed to protect key retinal cells, including photoreceptors, from cell death that occurs in 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. For its first indication, the company’s ONL1204 development program focused on the treatment of retinal detachment, a condition for which the compound has been granted orphan drug designation by the United States Food and Drug Administration (FDA). Clinical trial plans are focused first on the acute indication of retinal detachment, with the company continuing the preclinical work to enable clinical trials in other disease indications, including glaucoma, age-related macular degeneration (AMD), and inherited retinal degeneration (IRD; also known as retinitis pigmentosa).

About ONL Therapeutics ONL Therapeutics (ONL) is a clinical-stage biopharmaceutical company committed to protecting and improving the vision of patients with retinal disease. By advancing a novel breakthrough technology designed to protect key retinal cells from Fas-mediated cell death, ONL is pioneering an entirely 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.

Company Contact:
ONL Therapeutics, Inc.
Linda Kemnitz
lkemnitz@onltherapeutics.com