ONL1204 is designed to protect important retinal cells such as photoreceptors from cell death, which leads to vision loss and blindness. Credit: Karen Roe.

Biopharmaceutical company ONL Therapeutics has commenced a Phase I clinical trial to assess its investigational drug, ONL1204, for the treatment of macula-off rhegmatogenous retinal detachment (RRD).

ONL1204 is a small molecule Fas inhibitor intended to protect important retinal cells such as photoreceptors from cell death, which leads to vision loss and blindness.

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The drug candidate received orphan drug designation from the US Food and Drug Administration (FDA) to treat retinal detachment.

To be conducted at sites in Sydney and Melbourne, the Phase I trial will investigate the safety and tolerability of four different ONL1204 doses.

ONL estimates that the trial will run for around 12 months. Trial results are expected to facilitate plans for the development of the company’s retinal diseases portfolio in the future.

The company and its research partners performed site initiation visits and expects to start patient enrolment soon.

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ONL Therapeutics founder and chief scientific officer David Zacks said: “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.”

The company is planning for a Series B funding round to support the clinical development of ONL1204.

ONL will use the proceeds to bolster its pipeline of Fas inhibitors for the treatment of other retinal diseases, such as glaucoma, age-related macular degeneration (AMD) and inherited retinal degeneration.

In August, the company raised a $3m convertible note to speed-up its clinical development strategy.

ONL is currently supported by investments from Novartis, Invest Michigan, InFocus Capital Partners, the Capital Community Angels, the Biosciences Research & Commercialization Center, Hestia Investments and ExSight Ventures.