QLS-101 / Qlaris Bio - LARVOL DELTA

Preclinical Pharmacokinetic Profile of Topical Ophthalmic and Intravenous Delivery of QLS-101, a Novel ATP-Sensitive Potassium Channel Opening Ocular Hypotensive Agent. (PubMed, J Ocul Pharmacol Ther) - "Maximum tolerated dose was determined to be 3 mg/kg. QLS-101 was converted to its active moiety levcromakalim and showed characteristic absorption, distribution, and safety profiles of a well-tolerated prodrug."

Journal • PK/PD data • Preclinical • Glaucoma • Ophthalmology

Safety and Tolerability Study of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP) (clinicaltrials.gov) - P2 | N=2 | Completed | Sponsor: Qlaris Bio, Inc. | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Glaucoma • Ophthalmology

Safety and Tolerability Study of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP) (clinicaltrials.gov) - P2 | N=2 | Active, not recruiting | Sponsor: Qlaris Bio, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Glaucoma • Ophthalmology

Safety and Tolerability Study of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP) (clinicaltrials.gov) - P2 | N=5 | Recruiting | Sponsor: Qlaris Bio, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Glaucoma • Ophthalmology

A Study to Evaluate Safety and Tolerability of QLS-101 in NTG (clinicaltrials.gov) - P2 | N=30 | Completed | Sponsor: Qlaris Bio, Inc. | Active, not recruiting ➔ Completed

Trial completion • Glaucoma • Ophthalmology

Safety and Tolerability Study of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP) (clinicaltrials.gov) - P2 | N=5 | Not yet recruiting | Sponsor: Qlaris Bio, Inc. | N=20 ➔ 5

Enrollment change • Cardiovascular • Glaucoma • Ophthalmology

A Study to Determine the Safety and Tolerability of 2 Concentrations of QLS-101 (clinicaltrials.gov) - P2 | N=3 | Completed | Sponsor: Qlaris Bio, Inc. | Active, not recruiting ➔ Completed | N=12 ➔ 3

Enrollment change • Trial completion • Cardiovascular • Glaucoma • Ophthalmology

Emerging drugs for the treatment of glaucoma: A review of phase II & III trials. (PubMed, Expert Opin Emerg Drugs) - "However, the availability of generic prostaglandin analogs may limit adoption of these novel compounds as first line agents, except for certain subgroups of glaucoma patients. Use as adjuvant or second line therapy appears more likely for the majority of glaucoma patients."

Journal • P2 data • Review • Glaucoma • Ocular Inflammation • Ophthalmology • Optic Neuritis • Pain

Safety and Tolerability Study of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP) (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Qlaris Bio, Inc.

New P2 trial • Cardiovascular • Glaucoma • Ophthalmology

A Study to Evaluate Safety and Tolerability of QLS-101 in NTG (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: Qlaris Bio, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Glaucoma • Ophthalmology

Study to Evaluate QLS-101 Compared to Timolol Maleate Eye Drops in Subjects With High Eye Pressure (Glaucoma or Ocular Hypertension). (clinicaltrials.gov) - P2 | N=84 | Completed | Sponsor: Qlaris Bio, Inc. | Active, not recruiting ➔ Completed

Trial completion • Glaucoma • Ophthalmology

A Study to Determine the Safety and Tolerability of 2 Concentrations of QLS-101 (clinicaltrials.gov) - P2 | N=12 | Active, not recruiting | Sponsor: Qlaris Bio, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Glaucoma • Ophthalmology

Ocular Hypotensive Properties and Biochemical Profile of QLS-101, a Novel ATP-Sensitive Potassium (KATP) Channel Opening Prodrug. (PubMed, Invest Ophthalmol Vis Sci) - "Alkaline phosphatase was found to convert QLS-101 (mean Km = 630 µM, kcat = 15 min-1) to levcromakalim. QLS-101 is a novel KATP channel opening prodrug that when converted to levcromakalim shows 24-hour IOP lowering after once-daily topical ocular administration."

Journal

Study to Evaluate QLS-101 Compared to Timolol Maleate Eye Drops in Subjects With High Eye Pressure (Glaucoma or Ocular Hypertension). (clinicaltrials.gov) - P2 | N=84 | Active, not recruiting | Sponsor: Qlaris Bio, Inc. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Nov 2021 ➔ Feb 2022

Enrollment closed • Trial primary completion date • Glaucoma • Ophthalmology

A Study to Evaluate Safety and Tolerability of QLS-101 in NTG (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Qlaris Bio, Inc. | Trial completion date: Mar 2022 ➔ Jun 2022 | Trial primary completion date: Feb 2022 ➔ Jun 2022

Trial completion date • Trial primary completion date • Glaucoma • Ophthalmology

A Study to Determine the Safety and Tolerability of 2 Concentrations of QLS-101 (clinicaltrials.gov) - P2 | N=12 | Recruiting | Sponsor: Qlaris Bio, Inc. | Enrolling by invitation ➔ Recruiting

Enrollment status • Glaucoma • Ophthalmology

A Study to Determine the Safety and Tolerability of 2 Concentrations of QLS-101 (clinicaltrials.gov) - P2; N=12; Enrolling by invitation; Sponsor: Qlaris Bio, Inc.; Not yet recruiting ➔ Enrolling by invitation; Trial completion date: Dec 2021 ➔ Mar 2022

Clinical • Enrollment open • Trial completion date • Glaucoma • Ophthalmology

A Study to Determine the Safety and Tolerability of 2 Concentrations of QLS-101 (clinicaltrials.gov) - P2; N=12; Not yet recruiting; Sponsor: Qlaris Bio, Inc.; Initiation date: Jun 2021 ➔ Sep 2021

Clinical • Trial initiation date • Glaucoma • Ophthalmology

A Study to Determine the Safety and Tolerability of 2 Concentrations of QLS-101 (clinicaltrials.gov) - P2; N=8; Not yet recruiting; Sponsor: Qlaris Bio, Inc.

Clinical • New P2 trial • Glaucoma • Ophthalmology

A Study to Evaluate Safety and Tolerability of QLS-101 in NTG (clinicaltrials.gov) - P2; N=30; Recruiting; Sponsor: Qlaris Bio, Inc.; Not yet recruiting ➔ Recruiting

Enrollment open • Glaucoma • Ophthalmology

[VIRTUAL] Systemic and Ocular Toxicology and Pharmacokinetic Profiles of QLS-101, a Novel Topical IOP-Lowering Therapeutic (ARVO 2021) - "QLS-101 is well-tolerated in beagle dogs and suitable for clinical development as an IOP-lowering therapeutic."

PK/PD data • Ophthalmology

[VIRTUAL] Ocular Tissue Conversion and Activity Profile of QLS-101, a Novel Topical IOP-Lowering Therapeutic (ARVO 2021) - "QLS-101 is activated by human ALP to QLS-100, which promotes cell membrane hyperpolarization through ATP-sensitive potassium channels composed of Kir6.2/SUR2B."

Glaucoma • Ophthalmology

[VIRTUAL] Use of a Novel Potassium Channel Opener in a 3D-Glaucomatous Human Trabecular Meshwork/Schlemm’s Canal Tissue Model (ARVO 2021) - "QLS-100 significantly improved outflow facility in glaucomatous tissue constructs without impacting protein expression of fibrotic or endothelial junctional markers. Y27632 decreased expression of endothelial junctional markers, which may explain the hyperemia observed with clinical ROCK inhibition. These results indicate that the novel prodrug QLS-101 is a promising treatment that may lower elevated IOP without altering vessel integrity."

Glaucoma • Ophthalmology • CD31 • CDH5 • FN1 • NOS3 • TGFB1

A Study to Evaluate Safety and Tolerability of QLS-101 in NTG (clinicaltrials.gov) - P2; N=30; Not yet recruiting; Sponsor: Qlaris Bio, Inc.

Clinical • New P2 trial • Glaucoma • Ophthalmology

Study to Evaluate QLS-101 Compared to Timolol Maleate Eye Drops in Subjects With High Eye Pressure (Glaucoma or Ocular Hypertension). (clinicaltrials.gov) - P2; N=80; Recruiting; Sponsor: Qlaris Bio, Inc.

New P2 trial • Glaucoma • Hypertension • Ophthalmology