Qlaris gives update on trials evaluating QLS-111 in patients with ocular hypertension and glaucoma

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Qlaris Bio has announced the planned initiation and first dosing in Apteryx and Osprey Phase 2 trials of QLS-111 in patients with ocular hypertension (OHT) and glaucoma.

The company announced the first patient has been dosed in the Osprey trial, while the Apteryx trial is anticipated to begin within the next few weeks.

QLS-111 is an ATP-sensitive potassium channel modulator designed to reduce IOP by reducing episcleral venous pressure (EVP) and distal outflow resistance by relaxing vessels of the vascular and vascular-like tissues distal to the trabecular meshwork.¹ According to the company, no other current drug available directly addresses distal outflow and EVP in one. Qlaris believes the drug may offer a “significant and synergistic advantage in managing IOP.”

Barbara Wirostko, MD, FARVO, Chief Medical Officer of Qlaris discussed the initiation of the 2 trials in a press release from the company.¹

“We are very pleased to initiate these studies in support of QLS-111 clinical development,” said Wirostko. “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.”

Shan Lin, MD, Co-research director at the Glaucoma Center of San Francisco, a QLS‑111 investigational site, and member of the Qlaris Scientific Advisory Board commented on QLS-111 in the release.¹

“I’m very excited about the promise of QLS‑111, which in healthy, normotensive volunteers lowered pressure significantly from baseline,” said Lin. “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.”

Osprey study

The Osprey study (NCT06016972) will assess the safety, tolerability, and optimal dose of QLS-111 in adult patients who have primary open-angle glaucoma (POAG) and/or OHT.

The trial is a randomized, active- and vehicle-controlled, multi-site, double-masked study in approximately 60 patients. Three concentrations of QLS-111 will be evaluated compared to the vehicle; 0.015%, 0.03% and 0.075%.²

A secondary objective is to evaluate the ocular hypotensive efficacy of the 3 different concentrations of QLS-111 with once-daily morning (QAM), once daily evening (QPM), and twice daily (BID) dosing versus vehicle with QAM, QPM, and BID dosing.²

Apteryx study

The Apteryx study (NCT06249152) will evaluate safety and tolerability, as well as measure the additive IOP-lowering efficacy of QLS‑111 in combination with latanoprost versus latanoprost alone. Three concentrations of QLS-111 will be evaluated: 0.015%, 0.03% and 0.075%.³

The trial will be a multi-site, double-masked, vehicle-controlled, randomized, prospective parallel study of 14-day QPM dosing, followed by 14-day BID dosing of QLS-111, or vehicle, as concomitant therapy with monotherapy latanoprost. Both eyes will be dosed in the trial, and will consist of 7 visits and approximately 28 days of dosing.³

The Apteryx study includes patients 12-years and older with open-angle glaucoma and/or OHT who are currently treated with latanoprost.

References:

1. Qlaris Bio’s Novel IOP-Lowering Product, QLS-111, Is Dosed In Phase II Trials. Press release; 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/

2. Qlaris Phase 2 Study of QLS-111 in POAG and/​or OHT Patients. ClinicalTrials.gov. Updated March 19, 2024. Accessed April 2, 2024. https://clinicaltrials.gov/study/NCT06016972?tab=table

3. Qlaris Study of QLS-111 in Combination With a PGA for OAG and/​or OHT Patients. ClinicalTrials.gov. Updated March 19, 2024. Accessed April 2, 2024. https://clinicaltrials.gov/study/NCT06249152?tab=table