Claris Bio has closed on $118 million in Series B financing to support the next phase of growth for its lead investigational therapeutic, which targets limbal stem cell deficiency (LSCD).
Let’s start with Claris.
Based in New Jersey and initially funded in 2020, the late-clinical-stage biotechnology company operated in stealth mode until emerging in early 2024 with a new focus: developing therapies for corneal and ocular surface diseases—specifically: LSCD.
- Read up on this often misdiagnosed orphan disease, which—despite several current management methods—has no FDA-approved treatment available in the U.S. market.
Its lead investigational asset CSB-001 is currently under clinical investigation as a first-in-class eye drop option for LSCD.
Also worth a mention: The company recently announced major executive changes to its leadership.
Let’s take a closer look at this asset.
CSB-001 (oremepermin alfa ophthalmic solution) is intended to address the underlying pathophysiology (i.e., the “drivers” of vision loss) in LSCD by promoting corneal epithelial regeneration while modulating inflammation and fibrosis.
Its active ingredient: recombinant human deleted hepatocyte growth factor (dHGF), a naturally occurring human peptide with a small portion of its amino acids missing.
- What to know about dHGF:
- It’s involved in tissue repair, cell growth, and blood vessel formation.
- Its regenerative properties are key to providing corneal health maintenance and healing support.
Compare CSB-001 to current LSCD medical approaches.
Medical approaches that aren’t FDA-approved for the disease, to clarify.
With a “convenient administration” method, Claris said CSB-001 has the potential to offer a "transformative treatment option” extending beyond palliative care or surgery.
- “Current surgical approaches are limited to specialized centers and may require long-term systemic immunosuppression and have variable outcomes, underscoring the need for innovative, earlier, and accessible treatment options,” the company reasoned.
From cell transplants to topical or systemic anti-inflammatory medications, check out a few of these methods.
So how does this new financing factor in?
Starting with the basics of this: The Series B financing round was co-led by two new investors: Samsara Biocapital and Catalio. Participation also included eight other investors, composed of both new and existing.
The plan: For this $118 million to support Claris’s “next phase of growth” in advancing CSB-001 via:
- Completion of two ongoing LSCD-targeted clinical trials
- Proof-of-concept (POC) study
- Non-interventional natural history study
- Funding a planned pivotal program of CSB-001 for LCSD
- Expected to kick off H1 2027
Notably: The company said it is currently financed through phase 3 clinical evaluations for the asset.
Nice! Do we know the details for any of those trials?
Indeed we do …
For the POC study: This (ongoing) open-label phase 1 trial (NCT06452316) is evaluating CSB-001’s safety and efficacy among 63 patients (aged 18+) with LSCD.
- The design: Patients are receiving CSB-001 drops in either one or both eyes (four times daily [QID]) over a 20-week period, starting at either:
- Day 0
- Week 20 following a 20-week observational period
- Dosing completion: will be followed by an observational period
- Outcomes measures can be found here.
- Estimated completion: December 2027
And that non-interventional study?
Claris shared that it’s currently conducting the prospective, multicenter study (NCT07636590) among an estimated 500 LSCD patients (ages 12 to 99), with the intent for its outcomes to:
- Offer insights into LSCD’s natural history
- Characterize real-world LSCD management patterns
- Identify and qualify investigative sites and potential participants for planned pivotal studies
See here for the study’s outcome measures.
Has the company revealed anything on the pivotal program planned for 2027?
Yes! So far we know that the program will encompass two pivotal studies expected to evaluate the safety and efficacy of CSB-001 versus a vehicle. An estimated 400 LSCD will be enrolled.
As for the primary efficacy endpoint: Visual acuity (VA) supported by anatomical endpoints.
Stay tuned for updates on all four trials in the coming months!