Selagine, Inc., a spin-out company from the University of Chicago (UIC), has received FDA clearance for its investigational new drug (IND) application of its immunoglobulin (Ig) drop, currently under clinical evaluation for the treatment of dry eye disease (DED).
Let’s start with Selagine.
Founded in 2020, the clinical-stage company was kicked off within the UIC College of Medicine’s (COM) Department of Ophthalmology and Visual Sciences.
Its focus: Developing novel therapeutics for ocular surface diseases and quality of life improvements for patients with ocular conditions currently lacking “optimal therapies.”
- On the funding front: Selagine is supported by the National Institutes of Health’s National Eye Institute; Research to Prevent Blindness; as well as the UIC COM, Department of Ophthalmology and its Office of Technology Management's Proof-of-Concept Awards Program.
Talk more about its clinical focus.
The company’s lead product is a potential immunoglobulin (Ig) eye drop treatment for DED.
A quick Ig eye drop rundown: This formulation is a biologic drug consisting of functional antibodies obtained from the human plasma of healthy donors.
- Such functional antibodies are naturally-occurring and have the potential to neutralize inflammatory proteins directly involved in regulating OSD in dry eye patients.
- Case in point: A March 2024 clinical study evaluating intravenously (IVT)-administered Ig drops in a rabbit dry eye model found dry eye symptoms improved significantly over an 8-week trial—with no unexpected or serious adverse events (AEs).
Now to its lead asset.
Dubbed SLG-100 (also known as GRF312 Ophthalmic Solution), this is a biologic encompassing “pooled human (immunoglobulins)” that directly neutralizes and has natural protective antibodies against:
- DED-specific cytokine (protein) antibodies
- DED-specific autoantibodies
- Inflammatory actions on cells (T-cells, neutrophils, and dendritic)
- Note: T-cells play critical roles in DED development and progression
As such: The Ig drops provide “broad-spectrum anti-inflammatory actions,” Selagine noted.
How does this compare to other DED drugs on the market?
There’s a notable difference: Current FDA-approved and chronic DED-indicated therapeutics (including artificial tears and anti-inflammatories) focus primarily on targeting T-cell mediated inflammation.
Importantly: They do not have any direct actions against other DED-specific inflammatory cytokines or pathogenic autoantibodies.
Gotcha. Next: Talk more about SLG-100’s clinical performance thus far.
The clinical-stage product was previously tested in an early-stage (phase 1/2) pilot clinical trial among DED patients. Participants were dosed with the formulation twice a day (BID) for 8 weeks.
Per Selagine: SLG-100-treated participants exhibited fewer DED symptoms compared to placebo. There were also no reported differences in tolerability or AEs between the two groups.
Sounds promising … and what does this IND acceptance mean?
In general: An FDA-approved IND application enables a sponsor (company) to conduct human clinical trials with an experimental drug or biological product
- Importantly: INDs are considered a critical step in the U.S. regulatory and approval process for new therapeutics.
And in the case of this Ig eye drop?
The IND approval gives Selagine and its partner Grifols (see the next section for details on its involvement) the green light to conduct a phase 2 study on the investigational asset.
As Selagine founder and President Sandeep Jain, MD, stated: “The IND clearance opens the door to clinical trials for establishing the safety and efficacy of IG eye drops and brings us one step closer to meaningfully improving outcomes for people suffering from dry eyes.”
Real quick: What is Grifols, and how is it involved in this?
This Barcelona, Spain-based global healthcare company partnered with Selagine in 2023 as part of a global collaboration and licensing agreement for Selagine's Ig eye drops.
- Per this agreement: Selagine will develop the asset, and Grifols will retain the worldwide exclusive commercial rights (pending regulatory authorization).
- And in terms of clinical trials: Grifols is expected to fund the clinical development program (based on FDA approval).
- Read our coverage on this here.
Noted. So, what do we know about this planned phase 2 trial?
While no details were included in Selagine’s latest announcement, the company previously shared plans for a randomized, placebo-controlled, double-blind phase 2 trial back in 2023.
- However: According to Clinical Trials, that study was withdrawn (the last documented update is dated May 2023).
Stay tuned for more details!
And lastly: What’s the potential significance of the Ig eye drop?
If all goes well through its upcoming clinical evaluations, this eye drop treatment has the potential to become the first ocular surface-indicated medication for Grifol—and the first Ig-derived DED product in the United States.