QLS-101 is our lead program based upon research from the laboratory of Professor Michael Fautsch at Mayo Clinic. The original compounds were first synthesized at the laboratory of Professor Peter Dosa at the University of Minnesota.
QLS-101 is a novel prodrug of a well-characterized ATP-sensitive potassium (KATP) channel modulator that lowers intraocular pressure (IOP) by relaxing vessels of the vascular and vascular-like tissues distal to the Trabecular Meshwork, thereby reducing distal outflow resistance and lowering Episcleral Venous Pressure (EVP).
Though multiple mechanisms of action exist to lower IOP in patients with glaucoma, these agents all target only 3 of the 4 components of IOP as described by the Goldmann equation for IOP: the Aqueous Humor Inflow Rate (Q), Uveoscleral Outflow Rate (U), or Conventional Outflow Facility (C). There are currently no approved drugs that solely target the reduction of EVP. This leaves a significant gap in the potential to maximally lower IOP since EVP can be the largest determinant of overall IOP.
QLS-101 has shown efficacy in lowering IOP across multiple preclinical animal species, including mice, rabbits, dogs, and non-human primates, as well as in human eye explants. To date, QLS-101 has been demonstrated to be well-tolerated with no observed hyperemia in the efficacious dose range.
By uniquely targeting EVP and distal outflow, QLS-101 enables the treatment of diseases for which there are currently inadequate therapies: namely, those diseases of pathologic EVP or where EVP currently sets the floor for maximal therapy despite the use of multiple agents since no approved drugs currently lower EVP primarily.
Qlaris Bio has initiated clinical studies with QLS-101 in patients with Primary Open Angle Glaucoma, Ocular Hypertension, Normal Tension Glaucoma, and Sturge-Weber syndrome.
In addition to use as a monotherapy or in combination with other complementary mechanisms of action in Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OHT), QLS-101 may serve to be uniquely well-suited to additional unique indications.
Normal Tension Glaucoma
Treatment guidelines for patients suffering from Normal Tension Glaucoma (NTG) suggest lowering IOP as far as possible pharmacologically. However, EVP may limit the extent to which IOP may be lowered. By lowering EVP, QLS-101 could present a wholly new paradigm in the treatment of NTG, which can affect up to 40% of glaucoma patients in the US and strikingly, up to 90% of glaucoma patients in East Asia.
Sturge-Weber syndrome (SWS) is a Pediatric Rare Disease signified by a facial port wine birthmark. Patients with SWS can often suffer from severe, intractable glaucoma in the eye on the same side as their birthmark. Currently, therapies are limited and only modestly effective since SWS-related IOP elevation is caused by elevated EVP, for which current therapies are limited. By directly lowering EVP, QLS-101 may be uniquely well-suited to addressing this disease and improving the lives of SWS sufferers.
Additive Use with MIGS Devices
Minimally (micro) Invasive Surgery (MIGS) devices are a rapidly growing segment of the glaucoma therapy market. MIGS devices serve to obviate certain outflow pathways of the eye to alleviate elevated IOP. Certain devices, such as those that bypass the Trabecular Meshwork and shunt aqueous humor into the distal outflow vessels and Episcopal Veins, could be ideally suited to the combined use of QLS-101 which would allow the further lowering of IOP by the lowering of EVP which currently available pharmacotherapies are unable to provide.
Click the link below to learn more about our clinical study comparing QLS-101 with Timolol maleate in POAG and OHT patients at clinicaltrials.gov
Click the link below to learn more about our safety and tolerability study of QLS-101 in patients with Normal Tension Glaucoma at clinicaltrials.gov
Click the link below to learn more about our safety and tolerability study of QLS-101 in adult patients with Sturge-Weber syndrome at clinicaltrials.gov
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