ONL Therapeutics Announces First-In-Human Clinical Study with ONL1204

Lead candidate ONL1204 advances into Phase I clinical study in retinal detachment in Australia

ANN ARBOR, MI – October 8, 2019

ONL Therapeutics, Inc., a biopharmaceutical company developing novel therapies for protecting the vision of patients with retinal disease, today announced the initiation of 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).

“Today marks a major milestone in the history of ONL Therapeutics as we transition into a clinical-stage pharmaceutical company,” commented David Zacks, MD, PhD, Founder and Chief Scientific Officer of ONL Therapeutics. “We see great potential in the role of Fas inhibition to protect the vision of patients with retinal cell disease, and our first-in-human study with ONL1204 helps build the foundation to make a meaningful difference in the lives of patients.”

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 working with Novotech, the leading contract research organization throughout Asia, as we embark on our clinical development program with major clinical research centers in Australia,” said Jana van de Goor, PhD, Vice President of Development of ONL Therapeutics. “We recently conducted our site initiation visits with our research partners, and the teams are excited to begin enrolling patients in our study.”

The company anticipates the study will take approximately 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. The company’s ONL1204 development program focused its first indication 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 continuing preclinical work occurring 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

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