Qlaris Bio, Inc. (Dedham, MA) has announced that the first patient has been dosed in the Phase II Nightingale clinical trial evaluating QLS-111, the company’s lead investigational therapy, in patients with normal tension glaucoma(NTG).
The Nightingale study is Qlaris Bio’s third Phase II clinical trial of QLS-111 and will seek to build upon the positive clinical data generated in the previous Phase II Osprey and Apteryx clinical trials.
Notably, the Nightingale study will be conducted in South Korea, which provides access to a large NTG patient population due to its high prevalence in Asia.
QLS-111 is a first-in-class ATP-sensitive potassium channel modulator designed to lower intraocular pressure (IOP) by reducing episcleral venous pressure (EVP), a critical but previously unaddressed component of IOP that currently sets the floor for IOP lowering therapies. This novel mechanism is especially relevant for patients with NTG, whose IOPs remain within the “normal” range but who continue to experience disease progression.
“NTG is highly prevalent in Asia, and many of our patients struggle with ongoing vision loss despite IOPs that appear ‘normal’ by conventional standards,” said Ki Ho Park, Professor of Ophthalmology at Seoul National University College of Medicine and lead investigator of the study.
The Nightingale trial is a masked, randomized, Phase II study evaluating the safety, tolerability, and efficacy of QLS-111 in adult patients with NTG. The study is being conducted at multiple clinical sites across South Korea.
The Nightingale study is Qlaris Bio’s third Phase II clinical trial of QLS-111 and will seek to build upon the positive clinical data generated in the previous Phase II Osprey and Apteryx clinical trials.
Notably, the Nightingale study will be conducted in South Korea, which provides access to a large NTG patient population due to its high prevalence in Asia.
QLS-111 is a first-in-class ATP-sensitive potassium channel modulator designed to lower intraocular pressure (IOP) by reducing episcleral venous pressure (EVP), a critical but previously unaddressed component of IOP that currently sets the floor for IOP lowering therapies. This novel mechanism is especially relevant for patients with NTG, whose IOPs remain within the “normal” range but who continue to experience disease progression.
“NTG is highly prevalent in Asia, and many of our patients struggle with ongoing vision loss despite IOPs that appear ‘normal’ by conventional standards,” said Ki Ho Park, Professor of Ophthalmology at Seoul National University College of Medicine and lead investigator of the study.
The Nightingale trial is a masked, randomized, Phase II study evaluating the safety, tolerability, and efficacy of QLS-111 in adult patients with NTG. The study is being conducted at multiple clinical sites across South Korea.
