Novel therapeutic company Selagine, Inc and Spanish pharmaceutical company Grifols have entered into a global collaboration and licensing agreement to develop immunoglobulin eye drops for the treatment of dry eye disease (DED).
Refresh me on both companies.
Selagine is a spin-out company from the University of Illinois Chicago (UIC) focused on commercializing novel therapeutics for ocular diseases developed within the university’s College Of Medicine, Department of Ophthalmology.
The company’s lead product is a potential immunoglobulin eye drop treatment for DED: SLG-100.
Grifols is a global healthcare company based in Barcelona, Spain, that is developing plasma-derived—including proteins such as immunoglobulins—medicines and other biopharmaceutical solutions to treat immunodeficiencies and autoimmune disorders.
What is an immunoglobulin eye drop?
This type of eye drop is a biologic drug consisting of functional antibodies taken from human plasma of healthy donors. Naturally occuring, these antibodies might neutralize inflammatory proteins directly involved in modulating ocular surface disease (OSD) in dry eye patients.
Any clinical data already on immunoglobulins?
Indeed there is. Selagine’s SLG-100 was tested in an early-stage (phase 1/2) clinical trial in patients diagnosed with DED. Participants were dosed with the formulation twice a day for eight weeks.
According to the company, the SLG-100-treated participants exhibited fewer DED symptoms compared to placebo. There were also no reported differences in tolerability or adverse effects between the two groups.
A mid-stage (phase 2) randomized, placebo-controlled, and double-blind trial (NCT04510428) is also in the planning stages, with an expected enrollment of 40 participants, to test immunoglobulin drops against placebo.
Talk about the agreement.
Per the agreement, Grifols is to retain the worldwide exclusive commercial rights to the potential immunoglobulin treatment, which will be developed by Selagine, pending regulatory authorization (expected in early 2029).
Selagine will receive an upfront payment and annual collaboration fee; Grifols will fund the clinical development program (based on FDA approval), which will consist of clinical, manufacturing, and regulatory activities.
The program will be managed by both companies.
Anything else?
Financial details of the agreement were not disclosed.
Significance?
This eye drop treatment has the potential to become the first ocular surface-indicated medication for Grifol, as well as the first immunoglobulin-derived DED product.