Emmetrope Ophthalmics LLC (Emmecell) announced the final dose administration in the company’s U.S.-based study evaluating the safety and efficacy of its first-in-class cell therapy for the treatment of corneal edema.
Refresh me on the company.
Founded in 2011 and headquartered in Menlo Park, California, Emmecell is a privately held, clinical-stage biotechnology company developing cell-based therapies for various ocular diseases—including corneal edema and macular degeneration.
How it’s doing this: via its proprietary Magnetic Cell Delivery (MCD) nanoparticle platform.
Do tell.
The MCD platform incorporates a unique approach to regenerative medicine by using “magnetic nanoparticles to effectively localize and integrate cell therapies to the appropriate target tissue,” according to the company.
What makes it unique: Other cell therapies are typically limited in their capacity to replace or enhance damaged tissue due to an “inability to localize treatment to the site of injury or disease”—this platform is the exact opposite.
- Translation: The platform is intended to provide a safe and effective, microinvasive surgical approach to transplant corneal endothelial cells into the eye.
And its purpose: to solve the current challenges associated with standard cell therapies via the delivery, retention, and integration of cell therapies.
Now explain this cell therapy.
Emmecell’s EO2002 is formulated as a minimally-invasive cell therapy that injects healthy corneal endothelial cells taken from donor corneas into the eye using the MCD platform.
The intended result: to repopulate a patient’s diseased cornea with functional endothelial cells, potentially eliminating the need for transplantation.
And the trial?
The prospective, randomized, double-masked, multicenter, open-label, dose-escalation phase 1 study (NCT04894110) has enrolled 42 participants.
The criteria:
- Aged 21+
- Diagnosed with corneal edema associated with endothelial dysfunction, may be secondary toFuch’s corneal dystrophy
- Pseudophakic bullous keratopathy
How is it designed?
Participants are divided into two groups to receive three doses of EO2002 compared to EO2002 with and without endothelial brushing (EB) or Descemet Stripping (DS):
- Group 1
- EO2002 (with and without EB or DS)
- Group 2
- EO2002 (low dose)
- EO2002 (mid-dose)
- EO2002 (high-dose)
And what’s being measured?
The primary outcome measure is the number of treatment-emergent adverse events (TEAEs), as measured by the safety/tolerability of EO2002 (with and without EB and DS) at Week 26.
Secondary outcomes include the effect of EO2002 (with and without EB and DS) on:
- Corneal thickness (at Week 26)
- Best-corrected visual acuity (BCVA) (at Week 26)
And where is this being conducted?
At eight U.S. clinical sites across the country.
Note: The first U.S. patient from this trial was actually dosed back in July 2021.
And when can we expect data?
Per Clinical Trials, the study is expected to conclude by October 2024, so stay tuned for topline data!
Additionally: The company anticipates launching a phase 3 pivotal study within Q1 2025.
Editor’s note: This article was updated on July 10, 2024.