Selagine Enters into a Collaborative Agreement with Grifols for Development and Commercialization of Immunoglobulin Eye Drops for Treating Dry Eye Disease

Rhea-AI Summary

Selagine, Inc., a spin-out from the University of Illinois at Chicago, has partnered with Grifols (NASDAQ: GRFS) to develop immunoglobulin eye drops aimed at treating dry eye disease. This biologic eyedrop contains functional antibodies from human plasma, showing promising results in a pilot trial, significantly reducing dry eye symptoms without adverse effects compared to placebo. The agreement involves an upfront payment, annual fees, and joint funding for FDA approval. The dry eye market is forecasted to exceed $6.5 billion by 2027, highlighting the potential financial impact of this collaboration.

Positive

• Partnership with Grifols could accelerate development and commercialization of a novel treatment for dry eye disease.
• Pilot trial indicated significant symptom reduction in dry eye patients with no adverse effects compared to placebo.
• Potential for high revenue given the dry eye market projected to exceed $6.5 billion by 2027.

Negative

• None.

CHICAGO, March 6, 2023 /PRNewswire/ -- Selagine, Inc., a spin-out company from the University of Illinois at Chicago (UIC), announced today that it has entered into a research, development and sublicense agreement with Grifols (Nasdaq: GRFS), a global leader in plasma-derived medicines, for the development and commercialization of immunoglobulin eye drops for dry eye disease.

A novel biologic eyedrop that may change the treatment paradigm for dry eye disease

An immunoglobulin eye drop is a biologic drug that contains naturally occurring functional antibodies generated from human plasma collected from thousands of healthy donors. These antibodies can neutralize inflammatory proteins such as Interferon-gamma, Interlukin-17 and matrix metalloproteinase-9 that are implicated in producing ocular surface disease in dry eyes. In a first-in-human pilot clinical trial, immunoglobulin eye drops twice a day for eight weeks caused significant reduction in signs and symptoms of dry eyes with no difference in tolerability or adverse events as compared to placebo. Initial developmental work for these antibody-based biologic eye drops was performed in the Department of Ophthalmology and Visual Sciences at the University of Illinois College of Medicine, supported by UI Health Pharmacy, and is the outcome of over a decade of research and development efforts, with grant funding from the National Eye Institute (NEI)/National Institutes of Health (NIH), Research to Prevent Blindness and UIC's Office of Technology Management.

Inflammatory proteins (cytokines or chemokines), cells (neutrophils, T-cells and dendritic cells), complement system components and pathogenic antibodies are present on the ocular surface in chronic dry eye disease; therefore several different mechanisms of inflammation are simultaneously active and contribute to symptoms and signs of dry eye disease. Immunoglobulins have beneficial actions on each of these mechanisms; thus providing broad-spectrum anti-inflammatory actions and potentially providing mechanistic superiority over currently approved therapies for chronic dry eye disease. The anti-inflammatory actions of eye drops that are currently approved for treating chronic dry eye disease are narrow-spectrum and limited primarily to targeting T-cell inflammatory mechanisms.

"This collaboration builds upon complementary expertise of the two companies to provide a clear pathway to completing development and regulatory activities and executing a successful commercial launch of immunoglobulin eye drops for chronic dry eye disease indication," said Sandeep Jain, MD, founder and president of Selagine and B.A. Field professor of ophthalmology at University of Illinois College of Medicine. "With its strategic commitment to ophthalmics and its global leadership in immunoglobulins, we believe Grifols provides an ideal partner for realizing Selagine's goal of developing the full potential of plasma protein-based eye drops across all ophthalmic indications." Dr. Jain was assisted in the startup and development of Selagine by Michael Flavin, PhD, a research professor in the Colleges of Medicine and Pharmacy at UIC and a staff member at the university's Discovery Partners Institute. "Dr. Jain is the perfect example of a physician scientist entrepreneur who is successfully commercializing his technology," said Dr. Flavin. "The UIC College of Medicine and the Discovery Partners Institute are supporting stellar faculty members in advancing their exciting, cutting-edge discoveries toward the marketplace."

"The ability for research discoveries at universities to become therapies for patients relies upon collaboration with biopharmaceutical companies," said Mark Rosenblatt MD, PhD, MBA, MHA, executive dean of the University of Illinois College of Medicine. "We are so delighted that this novel application of immunoglobulin eye drops to treat dry eye disease has resulted from Dr. Sandeep Jain's world-class and innovative research work. This new sublicense agreement between Selagine and Grifols will facilitate the continued development of this therapeutic to potentially help the millions of patients around the world suffering from dry eye disease."

Under the agreement, Selagine will receive an upfront payment and annual collaboration fee. In addition, Grifols has committed to fund the development of immunoglobulin eye drops through FDA approval, which will be managed collaboratively by Grifols and Selagine, including the clinical, manufacturing and regulatory activities required for FDA approval for dry eye disease indication. Upon commercialization, Selagine will receive tiered royalties on net sales and milestone payments upon achievement of certain annual sales thresholds. Selagine will share a part of the royalties with UIC. "Grifols is extremely pleased to drive ophthalmological innovation to help patients, combining our industry-leading knowledge of immunoglobulins with Selagine's life-changing research and therapeutics to treat eye diseases," said Víctor Grifols Deu, co-CEO of Grifols. "We look forward to a close working relationship that will deliver important breakthroughs."

About Dry Eye Disease

Dry eye happens when the eyes don't make enough tears to stay wet, or when the tears don't work correctly. This can make the eyes feel uncomfortable, and in some cases it can also cause vision problems. Dry eye affects millions of Americans every year, especially older Americans and Women. Autoimmune conditions, such as Sjogren's syndrome, Rheumatoid Arthritis, Stevens-Johnson syndrome and ocular Graft-versus-Host-Disease are associated with a more severe form of dry eyes. As many as one-third of patients visiting an ophthalmology clinics report dry eye symptoms, making it one of the most common conditions seen by ophthalmology specialists. Dry Eye Disease is the 3rd biggest indication of the overall ophthalmology market. The global dry eye market size is projected to reach more than USD 6.5 billion by 2027.

For more information about Dry Eye, visit: https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/dry-eye

About Selagine

Selagine Inc. is a clinical-stage spin-out company from the University of Illinois at Chicago (UIC) that is commercializing technology which was developed within the College of Medicine, Department of Ophthalmology and Visual Sciences. Selagine is focused on developing novel therapeutics to help patients suffering from a variety of debilitating ocular diseases, and to improve the quality of life in conditions where effective therapies do not exist.

Selagine's office is located within the Illinois Medical District and its R&D laboratory is housed in UIC's Technology Innovation Lab, a hub for entrepreneurship and innovation at the University.

For more information, visit www.selagine.com

CONTACT: Media Press Office, info@selagine.com, 312-526-3725

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SOURCE Selagine, Inc

FAQ

What is the collaboration between Selagine and Grifols about?

Selagine and Grifols have entered an agreement to develop and commercialize immunoglobulin eye drops for treating dry eye disease.

What are the benefits of the immunoglobulin eye drops developed by Selagine?

The drops utilize antibodies that significantly reduce dry eye symptoms with no adverse effects, offering a potentially superior treatment.

When was the partnership between Selagine and Grifols announced?

The partnership was announced on March 6, 2023.

What is the significance of the dry eye market for Grifols?

The dry eye market is projected to surpass $6.5 billion by 2027, representing a substantial revenue opportunity for Grifols.

How will the development of the immunoglobulin eye drops be funded?

Grifols has committed to funding the development of the eye drops through FDA approval, sharing responsibilities with Selagine.