Ophthalmological disease company ONL Therapeutics is currently seeking investor capital or strategic partnerships to raise $75 –$100 million to run Phase II studies in geographic atrophy and open-angle glaucoma.
In an interview with Pharmaceutical Technology, ONL’s CEO David Esposito said the company is open to financing through its current investors and partners, whilst also being open to new opportunities, including those with larger pharmaceutical partners.
In March 2023, the company completed the first tranche of $15 million Series C Preferred Stock financing round for its Phase II retinal detachment trial. However, to further support the clinical development of the drug’s other indications the company will continue the Series C financing round. Esposito said the company plans to raise the necessary sum by mid-2024.
Pharmaceutical giants such as Johnson and Johnson and Novartis have invested in the Ann Arbor, Michigan-based ONL in the previous Series B financing round.
ONL’s lead candidate, ONL 1204, is currently in clinical trials for retinal detachment, open angle glaucoma and geographic atrophy. ONL 1204 is a small amino acid peptide that is delivered via intravitreal injection. The drug was granted an orphan drug designation in 2016 for retinal detachment by the US Food and Drug Administration.
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Esposito expects several clinical updates in the months to come. The company plans to release topline results from its Phase II retinal detachment trial in the second quarter of 2024. If these results are positive, Esposito foresees the initiation of a Phase III retinal detachment trial in late 2024 or early 2025. He also anticipates a Phase II/III registrational geographic atrophy trial and a Phase III glaucoma study to follow three to four years later.
The company has partnered with the artificial intelligence (AI)-focused British startup Novai to use its retinal biomarker DARC in its ophthalmology trials. Novai’s technology can rapidly identify stress cells and then an increase or decrease in those cells over time based on a treatment effect, says Esposito. “We hope that this can progress to become a principal biomarker to help us and others developing therapeutics for eye diseases,” he adds.
Esposito said the company may look to expand the drug’s use in the future to include more eye diseases such as acute glaucoma, central retinal vein occlusion or central retinal artery occlusion, and wet age-related macular degeneration.