Qlaris Bio, Inc. announced it has locked in a total of $24 million during its Series B financing round to support the ongoing clinical development of the company’s intraocular pressure (IOP)-lowering therapeutic.
Let’s start with Qlaris Bio.
Launched in 2019 and based in Wellesley, Massachusetts, the clinical-stage biotechnology is developing first-in-class therapeutics to treat serious and debilitating ophthalmic diseases with unmet needs, including:
- Normal-tension glaucoma (NTG)
- Primary open-angle glaucoma (POAG)
- Ocular hypertension (OHT)
- Sturge-Weber syndrome (SWS)
- Pediatric disease characterized by a facial port wine birthmark
- Ophthalmic link: These patients often have severe intractable glaucoma in the eye on the same side as their birthmark
Now this financing.
Led by early-stage venture capital firm Canaan and healthcare tech venture capital firm New Leaf Venture Partners, the company’s latest round of financing is reported to also include funds managed by newcomers abrdn Inc., Correlation Ventures, and Mayo Clinic Ventures.
Back to the Qlaris Bio … why focus on glaucoma?
The company noted three key areas of unmet needs associated with this disease:
- New mechanisms of actions (MOAs) that enable the treatment of glaucoma’s “unique aspects,” which are not being addressed with currently available therapeutics.
- Therapies with a sustained duration of action that reduce eye drop burden and controls IOP fluctuation on a daily basis.
- Novel neuroprotective therapies operating independently from IOP-lowering meds to both protect the optic nerve and preserve vision.
Now this IOP-lowering therapeutic.
To address the first of these three needs—new MOAs—Qlaris Bio has developed its lead program: QLS-111.
The investigational asset features a “unique vasodilatory” MOA and is designed to lower IOP by reducing episcleral venous pressure (EVP).
Why EVP is important: If left untreated, this clinical finding has been associated with elevated IOP and glaucoma, and has the potential to become the largest determinant of overall IOP.
Tell me more about its MOA.
Per the company, QLS-111 aims to lower IOP by “relaxing vessels of vascular and vascular-like tissues distal to the trabecular meshwork, thereby reducing distal outflow resistance and lowering EVP.”
Why this is key: There is currently no therapy approved for selectively targeting EVP reduction.
Any clinical data on it yet?
Funny you should ask … yes! Two U.S.-based phase 2 clinical trials evaluating QLS-111 for OAG and OHT are currently ongoing:
- Osprey (NCT06016972)
- Randomized, active- and vehicle-controlled, multi-site, double-masked study
- Participants: 60 (estimated; aged 18+)
- Evaluation of: placebo vs three doses of QLS-111 ophthalmic solution:
- 0.015%
- 0.03%
- 0.075%
- Duration: 21 days
- Applied every morning (QAM) for 7 days followed by every evening (QPM) for 7 days, then twice daily (BID) for 7 days
- Apteryx (NCT06249152)
- Pilot, double-masked, vehicle-controlled, randomized, prospective parallel study
- Participants: 48 (estimated; aged 12+)
- Evaluation of: placebo vs three doses of QLS-111 ophthalmic solution:
- 0.015%
- 0.030%
- 0.075%
- Duration: 28 days
- Applied QPM for 14 days followed by BID for an additional 14 days
And what’s being investigated?
Measured at the end of each study period, primary outcome measures for both studies include:
- Ocular symptoms and ocular treatment-emergent adverse events (TEAEs)
- Clinically significant changes in:
- Visual acuity (VA)
- Slit lamp exam findings
- Fundus exam findings
- Systemic TEAEs
- Blood pressure changes
- Heart rate changes
And secondary outcome measures, measured at the end of each study period, include:
- Change from baseline (CFB) of mean diurnal IOP in the study eye
- CFB in IOP at various time point in the study eye
When might we expect data?
Per Clinical Trials, the Osprey study is expected to conclude in September 2024, while the Apteryx is slated for October 2024.
Meanwhile, a third phase 2 study (NCT06030193) for NTG is expected to be initiated by the end of 2024.