Qlaris Bio has announced the enrolment of the first patient in the Phase I/II clinical programme of its lead investigational product candidate, QLS-101, for treating individuals with glaucoma.

A new adenosine triphosphate (ATP)-sensitive potassium (KATP) channel modulator administered as a topical eyedrop, QLS-101 is designed to reduce intraocular pressure (IOP) by reducing episcleral venous pressure (EVP) in glaucoma patients.

It is a novel prodrug of levcromakalim and was invented at Mayo Clinic and the University of Minnesota. QLS-101 is currently being developed under an exclusive worldwide licence.

The initiation of Phase I/II trial of QLS-101 comes after Qlaris Bio received the US Food and Drug Administration acceptance of investigational new drug application.

Named ‘Study QC-201’, the multi-centre, randomised, double-masked, active-controlled trial is analysing three concentrations of once-daily topical QLS-101 to timolol maleate preservative-free ophthalmic solution, a conventional glaucoma therapeutic.

Qlaris Bio CEO and co-founder Thurein Htoo said: “Our team has advanced QLS-101 to an IND filing in just 18 months following the founding of our company with a $25m Series A financing co-led by Canaan and New Leaf Venture Partners.

“The unique profile of QLS-101 has generated strong interest in an EVP-lowering therapy among leading ophthalmologists, researchers, patients, and investors.”

The company noted that QLS-101 enhances the outflow of aqueous humour, a fluid that preserves pressure in the eye.

Qlaris Bio chief medical officer and co-founder Barbara Wirostko said: “By reducing EVP, QLS-101 represents a unique approach to enable the achievement of even lower IOP targets than available therapies currently allow.

“The availability of a once-daily topical eyedrop formulation that targets EVP would help address a key component of the IOP puzzle that current medical management may not adequately address, particularly in underserved patient populations.”

The QLS-101 clinical programme also comprises two additional Phase I/II studies, which are set to begin later this year in subjects with normal-tension glaucoma and adults with Sturge Weber syndrome-related glaucoma.