Qlaris Bio announces initiation for 2 Phase 2 trials of QLS-111 for lowering IOP

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Clinical-stage biotechnology company Qlaris Bio is now initiating and dosing for 2 separate Phase 2 clinical trials investigating QLS-111 in patients with ocular hypertension (OHT) and glaucoma, according to a news release. QLS-111 is intended to lower IOP beyond levels currently achievable in patients with glaucoma by targeting episcleral venous pressure (EVP.)¹

“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,” said Thurein Htoo, Qlaris Bio CEO in the 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.”

Both the trials, Osprey and Apteryx, are masked and randomized. The Osprey study 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 OHT. The trial’s secondary endpoint is the efficacy of QLS-11 regarding lowered IOP. For the Apteryx study, safety and tolerability will be measured, in addition to measuring the additive IOP-lowering efficacy, of QLS-111 in combination with latanoprost versus latanoprost alone. Patients with open-angle glaucoma and/or OHT currently on latanoprost and aged 12 years or older are qualified for trial enrollment.¹

“We are very pleased to initiate these studies in support of QLS-111 clinical development,” said Barbara Wirostko, MD, FARVO, chief medical officer for. Qlaris, in the release. “Despite the number of therapies currently available to clinicians, there remains a critical unmet need for new drugs that target unique parameters within IOP regulation with a strong safety profile. With a novel mechanism of action that targets EVP, as well as early data demonstrating it may be used in combination with existing treatments, QLS-111 has the potential to make a significant impact.”

QLS-111 is an ATP-sensitive potassium channel modulator that works to reduce IOP by reducing EVP and distal outflow resistance, which may make it suitable for treating POAG, OHT, and normal tension glaucoma. Currently, medications that treat glaucoma either reduce aqueous humor production or target proximal outflow. No medications on the market 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,” the release stated.

“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, which acts as a QLS-111 investigational site. Lin is also 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,” Lin concluded.

Reference:

1. Qlaris Bio’s novel IOP-lowering product, QLS-111, is dosed in Phase 2 trials. Qlaris Bio. News release. Published April 2, 2024. Accessed April 2, 2024. https://qlaris.bio/qlaris-bios-novel-intraocular-pressure-iop-lowering-product-qls-111-is-dosed-in-phase-ii-trials/