Policy & Regulation
Qlaris Bio Reports Phase 2 Clinical Trial Results Demonstrating Favorable Safety and Tolerability Profile and Positive Efficacy Signal for QLS-101
19 May 2022 - - US-based biotechnology company Qlaris Bio, Inc has posted results from QC-201, a first-in-human, Phase 2 clinical trial of QLS-101, the company's investigational therapy for lowering intraocular pressure in the treatment of glaucoma, the company said.

Study findings demonstrated a favorable safety and tolerability profile for QLS-101, including no evidence of hyperemia (eye redness), as well as a positive efficacy signal, in patients with primary open-angle glaucoma or ocular hypertension.

These data support the ongoing clinical development of QLS-101 and Qlaris intends to initiate several new studies designed to further assess the potential role of the compound as a first-in-class glaucoma treatment.

Additional clinical trials will seek to evaluate QLS-101 as a complementary therapy to available glaucoma treatments and procedures, such as prostaglandin analogs and minimally invasive glaucoma surgery, and as a treatment for juvenile patients with Sturge-Weber syndrome -related glaucoma.

QLS-101 is a novel adenosine triphosphate -sensitive potassium channel modulator administered as a topical eyedrop. Unlike currently available therapies for lowering IOP in glaucoma, QLS-101 targets distal outflow resistance and episcleral venous pressure, a key component of IOP.

QLS-101 improves the outflow of aqueous humor by widening outflow channels and the episcleral vessels of the eye distal to the trabecular meshwork to lower IOP.

POAG is the most common adult form of glaucoma and remains one of the leading causes of preventable blindness worldwide. Elevated IOP remains the only modifiable risk factor for progression of glaucoma.

Despite available therapies and surgical interventions, patients with POAG may not achieve IOP-lowering goals as available options only target three components of IOP.

This leaves the fourth component of IOP -- EVP -- insufficiently addressed.

SWS is a pediatric rare disease signified by a facial port wine birthmark. Individuals living with SWS often suffer from severe, intractable glaucoma in the eye on the same side as their birthmark.

In these individuals, increased IOP is driven by pathologically elevated EVP.

By directly lowering EVP, QLS-101 may be uniquely well-suited to address SWS and improve therapeutic outcomes.

QLS-101, Qlaris Bio's lead product candidate, is a prodrug of levcromakalim, an adenosine triphosphate -sensitive potassium channel modulator.

By lowering episcleral venous pressure and increasing aqueous humor outflow through vessels distal to the trabecular meshwork, QLS-101 may be able to uniquely address diseases of pathologic EVP resulting in elevated intraocular pressure, such as Sturge-Weber syndrome-related glaucoma, and diseases where EVP limits maximal therapy, including primary open-angle glaucoma and normal-tension glaucoma.

QLS-101 was invented at Mayo Clinic and the University of Minnesota and is being developed under an exclusive worldwide license.

Qlaris Bio, Inc. was founded in August 2019 with a singular focus: to develop novel, innovative therapies with first-in-class mechanisms of action to address serious and debilitating ophthalmic diseases.

The company's lead platform is based on the use of adenosine triphosphate -sensitive potassium channel modulators to affect the tone of vascular and vascular-like tissues, initially focused on ophthalmic use.

Qlaris Bio's investors include Canaan and New Leaf Venture Partners, both of which were co-lead investors in the company's USD 25m series A round in August 2019.

Other investors include Correlation Ventures and Mayo Clinic.
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