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Qlaris Bio Announces First Patient Dosed in Phase II Nightingale Clinical Trial in Normal Tension Glaucoma Patients

via Business Wire

Third study in Phase II program expands global clinical development of QLS-111 in patients with no previously approved treatment options

Study to be conducted in South Korea where there is a high prevalence of Normal Tension Glaucoma

Qlaris Bio, Inc., a clinical-stage biotechnology company targeting unmet needs in debilitating ophthalmic diseases, today announced that the first patient has been dosed in the company’s 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, 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.”

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. It follows Qlaris Bio’s recent U.S.-based Phase II studies, Osprey and Apteryx, 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.

“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.”

About QLS-111

QLS-111 is a novel topical ATP-sensitive potassium channel modulator that reduces IOP by lowering EVP. The compound was originally discovered in the laboratory of Dr. Michael Fautsch at the Mayo Clinic and has been developed into Qlaris Bio’s bespoke, non-preservative formulation, QLS‑111. Studies have demonstrated that treatment with QLS‑111 provides persistent lowering of IOP, maintains normal vascular integrity of the venous system, is well-tolerated, and does not cause added hyperemia. The formulation has shown promising results in the Phase II Osprey and Apteryx clinical trials in patients with open angle glaucoma (OAG) and ocular hypertension (OHT).

About Qlaris Bio, Inc.

Founded in August 2019, Qlaris Bio is a clinical-stage biotechnology company focused on developing innovative ophthalmic therapies with first-in-class mechanisms of action. The company’s lead candidate, QLS‑111, is designed to address a significant gap in glaucoma treatment by targeting EVP. For more information, please visit www.qlaris.bio.

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