Qlaris Bio’s Novel IOP-Lowering Product, QLS‑111, is Dosed in Phase 2 Trials

Qlaris Bio announced the initiation and dosing of two separate US phase 2 masked, randomized clinical trials investigating QLS‑111 in patients with ocular hypertension and glaucoma.

“The start of these phase 2 trials represents a key milestone in our goal of bringing QLS‑111 to glaucoma patients for whom consistent IOP lowering and control has been an unachievable goal,” Thurein Htoo, Chief Executive Officer of Qlaris, said in a company news release. “IOP remains the only modifiable risk factor for the treatment of glaucoma, and additional treatments are needed for patients. QLS‑111 has the potential to change the treatment paradigm by effectively reducing IOP by lowering EVP, an unaddressed component of IOP.”

Qlaris is initiating the following studies:

• The Osprey study (NCT06016972) will assess the safety, tolerability, and optimal dose of QLS‑111 compared with vehicle alone in adult patients who have primary open-angle glaucoma (POAG) and/or ocular hypertension (OHT). The efficacy of QLS-111 in lowering IOP will be assessed as a secondary endpoint of the trial.
• The Apteryx study (NCT06249152) will evaluate the safety and tolerability, and measure the additive IOP-lowering efficacy, of QLS‑111 in combination with latanoprost versus latanoprost alone. Patients aged 12 years or older and who have open-angle glaucoma (OAG) and/or OHT currently on latanoprost will be enrolled in the trial.

QLS‑111 is an ATP-sensitive potassium channel modulator that is designed to reduce IOP by reducing EVP and distal outflow resistance, making it potentially suitable for treating POAG, OHT, and normal tension glaucoma (NTG). Current medications fall into two categories, those that reduce aqueous humor production and those that target proximal outflow. However, none of the current medications directly address distal outflow and EVP. This is important as EVP contributes up to 50% of total IOP, often leaving patients unable to reach IOP reduction goals to slow their disease progression, despite currently available therapies. QLS‑111's complementary mechanism may offer a significant and synergistic advantage in managing IOP.

“I’m very excited about the promise of QLS‑111, which in healthy, normotensive volunteers lowered pressure significantly from baseline,” said Shan Lin, MD, Co-Research Director at the Glaucoma Center of San Francisco—a QLS‑111 investigational site—and a member of the Qlaris Scientific Advisory Board. “This suggests that QLS‑111 will benefit patients who do not adequately respond to currently available drugs due to the IOP floor set by EVP. Importantly, this compound has demonstrated that it can work alone or in combination with several current glaucoma drug classes, indicating that its use with current medications will aid in the ability to achieve levels of IOP reduction that slow disease progression. With its strong safety profile and no clinically meaningful hyperemia, QLS‑111 holds enormous promise for our patients.”