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ONL Therapeutics Strengthens Leadership with Appointment of Penny Fleck as Chief Development Officer

ONL Therapeutics, Inc. has announced the appointment of Penny Fleck as Chief Development Officer, bringing over twenty years of pharmaceutical R&D experience to the role. Fleck will lead the development of ONL1204 Ophthalmic Solution, aimed at treating retinal diseases, as the company prepares for a Phase 2 clinical study in geographic atrophy associated with age-related macular degeneration.

ONL Therapeutics Appoints Penny Fleck as Chief Development Officer

ANN ARBOR, Mich. – ONL Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing novel therapies for retinal diseases, has appointed Penny Fleck as its new Chief Development Officer. Fleck will oversee all development activities for ONL1204 Ophthalmic Solution, the company's lead asset, leveraging her extensive experience in pharmaceutical research and development.

A Proven Leader in Ophthalmology Clinical Development

With over two decades of experience in leading R&D organizations and portfolio clinical development strategies at major pharmaceutical companies, Fleck's expertise is expected to be pivotal for ONL Therapeutics. Her previous role as Vice President and Global Head of Specialty Ophthalmology Clinical Development at Johnson & Johnson Innovative Medicine saw her leading the clinical development organization and building a portfolio focused on retinal conditions.
"Penny is a proven leader, and her demonstrated experience leading ophthalmology clinical development will be a critical asset to our company as we continue to advance ONL1204 toward a planned Phase 2 clinical study in geographic atrophy associated with age-related macular degeneration," said David Esposito, CEO of ONL Therapeutics.

Advancing ONL1204 Through Clinical Trials

ONL1204 is a first-in-class small molecule Fas inhibitor designed to protect key retinal cells from cell death, addressing the root cause of vision loss in various retinal diseases. The company is currently preparing for a Phase 2 global study targeting geographic atrophy (GA) associated with dry age-related macular degeneration (AMD), following a successful $65 million Series D financing round led by Johnson & Johnson Innovation - JJDC, Inc.
"It is an incredibly exciting time to join the ONL Therapeutics team, with the company moving into mid-stage clinical development," Fleck commented. "With its unique and differentiated Fas inhibition platform, the company is well positioned to continue driving innovation in areas of significant unmet medical need, including GA, glaucoma, and other indications."

ONL1204's Clinical Development Program

ONL Therapeutics' clinical development program for ONL1204 includes several key studies:
  • A Phase 2 study for GA associated with AMD (NCT06659445)
  • A completed Phase 2 study in the U.S. for macula-off retinal detachment (RD), for which ONL1204 has received orphan drug designation from the FDA (NCT05730218)
  • A Phase 1b clinical trial in patients with GA associated with AMD (NCT04744662)
  • A Phase 1b clinical trial in patients with progressing open-angle glaucoma (NCT05160805)
  • A Phase 1 clinical trial in macula-off RD patients in Australia and New Zealand (NCT03780972)

About ONL Therapeutics

ONL Therapeutics is dedicated to developing first-in-class therapeutics to protect and improve the vision of patients with retinal diseases. By focusing on protecting key retinal cells from Fas-mediated cell death, ONL Therapeutics is pioneering a new approach to preserving vision.
For more information, visit www.onltherapeutics.com.
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Reference News

[1]
ONL Therapeutics Appoints Penny Fleck as Chief Development Officer
manilatimes.net · Jan 7, 2025

ONL Therapeutics appoints Penny Fleck as chief development officer to lead ONL1204 Ophthalmic Solution's development. Fl...

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