Grifols, S.A. announced it is partnering with the Center for the Biomedical Advanced Research and Development Authority (BARDA) to clinically test investigational ocular surface immunoglobulin (OISG) eye drops and evaluate their treatment of ocular damage from sulfur mustard exposure.
That’s … a lot. Let’s start with Gifols.
Based in Barcelona, the global healthcare company is a pharmaceutical and chemical manufacturer of—primarily—blood plasma-based products (with +390 donation centers in North America, Europe, Africa, the Middle East, and China).
- Its other areas of operation include supplying devices, instruments, and reagents for clinical testing laboratories in 110+ countries.
Grifols’ focus includes treating conditions in such therapeutic areas as:
- Immunology
- Hepatology and intensive care
- Pulmonology
- Hematology
- Neurology
- Infectious diseases
Now BARDA.
Reporting to the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), BARDA provides an integrated system of medical countermeasures for public health emergencies.
Its work: Involves collaborating with the biomedical industry via grants and other forms of assistance to promote advanced research, innovations, and development of medical devices, tests, vaccines, and therapeutics.
Now to this collaboration.
The focus: sulfur mustard—also known as mustard gas.
What it is: A man-made, chemical warfare (blister) agent that can cause severe, delayed burns to the eyes, skin, and respiratory tract.
- The ocular-specific effect: It’s known to react rapidly with ocular tissue, damaging cells within minutes of contact and leading to pain, photophobia, and mustard gas keratopathy, a vision-loss-based corneal injury.
And the clinical testing plans?
Via a preclinical evaluation of OSIG eye drops conducted in partnership with BARDA, Grifols intends to develop a treatment for sulfur mustard ocular exposure by “repurposing an investigational OSIG therapeutic” already in clinical development for dry eye disease (DED), according to the company.
- Note: We’ll get to that investigational candidate in a moment.
The intent behind this: To identify and provide potential evidence of “anti-inflammatory and immunomodulatory properties” of OSIG—plus its efficacy in alleviating long-term effects associated with sulfur mustard exposure.
And how will this evaluation identify these properties, exactly?
Essentially, by determining how the anti-inflammatory properties of OSIG can block the immune system from accidentally attacking self-antigens and, instead, target these antigens while also neutralizing the immune response.
In this scenario: These “self-antigens” are proteins modified via sulfur mustard gas exposure.
And the intended result: OSIG would, ideally, aid in protecting ocular tissue and assist in sulfur mustard-exposed recovery.
Gotcha. Now circle back to that DED treatment in clinical development.
Luckily for you, we reported on this back in March 2023.
A brief recap: Grifols and Selagine, Inc., a spin-out therapeutic company from the University of Chicago, launched a collaboration to co-develop Selagine’s investigational immunoglobulin eye drops for DED.
- Side note: Get a rundown on immunoglobulin eye drops.
About that treatment: Known as SLGT-100, the eye drop was previously tested in an early-stage clinical trial among DED patients, where they were dosed twice a day (BID) for eight weeks.
So what’s the plan following Grifols’ preclinical evaluation of SLGT-100?
If successful, the FDA may “eventually license what would be one of the first medical treatments to counteract the long-term effects of sulfur mustard ocular injury,” Grifols noted.
Go on …
At the time of its co-development announcement, Grifols also noted that SLGT-100 has the potential to become the first ocular surface-indicated medication for Grifols, as well as the first immunoglobulin-derived DED product.
The anticipated time frame (as of now): For SLGT-100 to enter clinical development in H1 2025 via a phase 2 clinical trial.
Which means?
As always, stay tuned!