Qlaris Bio has announced the dosing of the first patient in its Phase II Nightingale clinical trial evaluating QLS-111 in patients with normal tension glaucoma (NTG). The masked, randomized study represents the company's third Phase II trial of its lead investigational therapy and will be conducted at multiple clinical sites across South Korea, where NTG has high prevalence.
Novel Mechanism Targets Previously Unaddressed Component
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, MD, PhD, Professor of Ophthalmology at Seoul National University College of Medicine and lead investigator of the Nightingale study. "We are excited to evaluate QLS-111. A therapy that targets EVP may offer a much-needed new strategy for pressure reduction and disease control in this population."
Building on Positive Phase II Results
The Nightingale study will seek to build upon positive clinical data generated in previous Phase II Osprey and Apteryx clinical trials, both of which demonstrated promising safety and efficacy of QLS-111 in patients with ocular hypertension and open angle glaucoma, including when administered in combination with latanoprost.
Data released in February showed that in the Osprey study, the 0.015% concentration dosed once daily in the evening drove the greatest decrease in IOP, with mean reductions of 3.7 mmHg from mean diurnal baseline IOP of 23.0 mmHg. The Apteryx trial found that QLS-111 0.015% dosed with latanoprost demonstrated additive mean IOP reductions when compared to latanoprost monotherapy, achieving a 3.2 mmHg greater reduction for QLS-111 evening dosing and 3.6 mmHg greater reduction for QLS-111 twice daily dosing.
Strategic Geographic Focus
The choice to conduct the Nightingale study in South Korea provides access to a large NTG patient population due to the disease's high prevalence in Asia. This geographic strategy allows Qlaris Bio to expand its global clinical development program while targeting a population with significant unmet medical needs.
"The initiation of the Nightingale study is an exciting milestone in our mission to address unmet needs in glaucoma," said Thurein Htoo, Chief Executive Officer of Qlaris Bio. "We believe that targeting EVP is a fundamentally new and important mechanism that can benefit many patients worldwide, especially as a complement to other therapies for patients requiring further IOP control without added side effects, such as hyperemia."
Fixed-Dose Combination in Development
Qlaris Bio announced in June that a QLS-111 and latanoprost fixed-dose combination (QLS-111-FDC) is in development for the treatment of primary open-angle glaucoma, ocular hypertension, and normal-tension glaucoma in patients whose optimal IOP control may remain "unachievable" due to needing an EVP reduction. The novel preservative-free therapy demonstrated more than 33 mmHg of additional IOP reduction compared with latanoprost monotherapy alone, according to Phase II clinical study data. Additionally, no incremental hyperemia was observed when QLS-111 0.015% was added to latanoprost.
