Phase II Trials Initiated for Qlaris Bio's QLS-111 IOP-Reducer

A groundbreaking new drug, QLS-111, is being developed by Qlaris Bio, Inc., a clinical-stage biotechnology firm, to treat glaucoma by tackling a previously unaddressed aspect of intraocular pressure (IOP). The company has recently commenced two distinct Phase II clinical trials in the U.S. to evaluate the efficacy and safety of QLS-111 in patients with ocular hypertension and glaucoma.

Thurein Htoo, the CEO of Qlaris, emphasized the significance of these trials, stating that QLS-111 could potentially offer a new approach to managing IOP for glaucoma patients who have struggled to achieve adequate control with existing treatments. The drug is designed to lower IOP by addressing the episcleral venous pressure (EVP), a component that has not been targeted by current medications.

The Osprey study is set to determine the optimal dosage and assess the safety and tolerability of QLS-111 in adults with primary open-angle glaucoma or ocular hypertension. The Apteryx study will investigate the drug's safety, tolerability, and its additional effect on IOP reduction when used alongside latanoprost, a common glaucoma medication, in patients aged 12 and above.

Barbara Wirostko, the Chief Medical Officer at Qlaris, highlighted the unmet need for innovative drugs that can target unique IOP parameters with a strong safety profile. QLS-111, with its novel mechanism targeting EVP, could significantly impact the treatment landscape for glaucoma.

QLS-111 operates by modulating ATP-sensitive potassium channels, which helps to reduce IOP by decreasing EVP and distal outflow resistance. This makes it a promising candidate for treating various forms of glaucoma, including primary open-angle glaucoma, ocular hypertension, and normal tension glaucoma. Unlike current treatments that focus on reducing aqueous humor production or targeting proximal outflow, QLS-111 is unique in that it addresses the distal outflow and EVP, which can account for up to 50% of total IOP.

Dr. Shan Lin, Co-Research Director at the Glaucoma Center of San Francisco and a member of Qlaris's Scientific Advisory Board, expressed excitement about the drug's potential, noting its ability to significantly lower pressure in healthy volunteers and suggesting that it could benefit patients who do not respond well to current drugs. Importantly, QLS-111 has shown a strong safety profile and no clinically significant hyperemia.

QLS-111 is based on a novel topical formulation developed by Dr. Michael Fautsch, a professor at the Mayo Clinic, and utilizes Qlaris Bio's ATP-sensitive potassium channel modulator platform. The drug works by relaxing the vessels in the distal vascular tissues of the eye, thereby reducing EVP.

Qlaris Bio, founded in 2019, is dedicated to developing innovative therapies for serious ophthalmic diseases. The company's lead program, QLS-111, represents a first-in-class approach to improving eye outflow through distal vascular tissues to reduce IOP. Qlaris Bio's investors include Canaan and New Leaf Venture Partners, among others, and the science behind QLS-111 originated at the Mayo Clinic.