Qlaris Bio Reports Positive Phase II Results for QLS-111 in Glaucoma and Hypertension Patients

DEDHAM, Mass.--Qlaris Bio, Inc., a biotech firm at the clinical stage, has announced promising results from two Phase II clinical trials in the United States. These trials were conducted to evaluate the efficacy and safety of QLS-111, a novel treatment targeting primary open-angle glaucoma (POAG) and ocular hypertension (OHT). The trials, named Osprey and Apteryx, successfully achieved all their primary and secondary objectives.

The Osprey trial, conducted under the identifier NCT06016972, was a masked, randomized study involving 62 adult participants diagnosed with POAG or OHT. This trial aimed to evaluate the safety, tolerability, and intraocular pressure (IOP)-reducing effects of various doses of QLS-111 compared to a placebo. Results showed that a 0.015% concentration of QLS-111 administered once daily in the evening led to the most significant reduction in IOP, with an average decrease of 3.7 mmHg from a baseline IOP of 23.0 mmHg.

Similarly, the Apteryx trial (NCT06249152) was a masked, randomized study focused on assessing the safety, tolerability, and additional IOP-lowering effectiveness of QLS-111 when used alongside latanoprost, compared to latanoprost alone. This trial involved 32 participants aged 12 and older who had POAG or OHT and were stable on latanoprost monotherapy. The baseline IOP for these patients was 19.8 mmHg. The combination of QLS-111 at 0.015% with latanoprost resulted in an enhanced mean reduction in IOP, achieving a 3.2 mmHg greater decrease with once-daily dosing and a 3.6 mmHg greater decrease with twice-daily dosing compared to latanoprost alone.

Crucially, all concentrations and dosing regimens of QLS-111 across both trials demonstrated excellent safety and tolerability profiles. No serious adverse events were reported, and there were no observations of significant hyperemia or other ocular or systemic side effects. Notably, no additional hyperemia occurred when QLS-111 was added to latanoprost treatment.

Qlaris Bio's Chief Executive Officer, Thurein Htoo, expressed satisfaction with the performance of QLS-111 in the Phase II trials. The findings bolster their confidence in the potential of QLS-111 to serve as a first-in-class therapeutic, given its novel preservative-free formulation that selectively targets episcleral venous pressure (EVP).

Dr. Barbara Wirostko, Chief Medical Officer at Qlaris Bio, emphasized the synergistic capacity of QLS-111 in providing significant IOP reduction in patients already treated with latanoprost. This substantial additive effect could benefit patients who do not achieve desired IOP lowering with existing treatments. Moreover, the encouraging tolerability of QLS-111 may enhance patient compliance and adherence to treatment, as indicated by the absence of clinically significant hyperemia and no corneal changes or other relevant ocular or systemic findings.

Professor Ike Ahmed, Director at the Alan S. Crandall Center for Glaucoma Innovation, commented on the promising nature of the Phase II data, highlighting the innovative therapy's potential. With its appealing safety profile and ability to enhance the efficacy of other glaucoma medications, QLS-111 could help maintain better IOP control for patients. The strong results from the Osprey and Apteryx trials suggest that this treatment could soon provide an important new option for addressing unmet needs in glaucoma care. Additionally, combining QLS-111 with minimally invasive glaucoma surgeries (MIGS) targeting trabecular meshwork could further optimize treatment outcomes.

QLS-111 represents a groundbreaking topical formulation utilizing Qlaris Bio's ATP-sensitive potassium channel modulator platform, initially developed by Michael Fautsch at the Mayo Clinic. This formulation lowers IOP by relaxing the vessels in tissues distal to the trabecular meshwork, thereby reducing distal outflow resistance and EVP. While there are various mechanisms to lower IOP in glaucoma patients, QLS-111 uniquely targets EVP reduction, a previously unmet therapeutic need that could significantly enhance IOP management.