Posted on Aug 25, 2020, 6 p.m.
The San Diego based biotech Trefoil Therapeutics is getting ready to launch clinical trials of a drug that is designed to treat a condition in which some of the eye’s cells die off leading to loss of vision.
The drug is suggested to target cells in the cornea which is the clear outer layer that covers the front of the eye, and focuses light onto the back of the eye where it will be converted into electrical signals that run to the brain allowing humans to see.
When cells along the bottom of the cornea die off the eye has trouble focusing light which leads to reduced vision or blindness. According to the National Institutes of Health this condition is estimated to happen in at least 4% of adults over the age of 40 due to a combination of age and genetics.
In most cases of this condition the standard treatment is a corneal transplant, but patients must take drugs that will suppress their immune system to avoid rejection of the transplanted tissue. These immune suppressing drugs most often have unwanted side effects, which is why the biotech has been working to find a different approach to treat this condition.
"We're trying to make the tissue you already have, the cells that you already have, regenerate," said CEO David Eveleth.
The drug is a modified form of a naturally occurring protein called fibroblast growth factor 1 which signals cells to grow, and the trials will be testing a version of this protein that has been modified to be longer lasting than the natural form. The biotech plans to enroll 70 participants with moderate to severe loss of corneal cells, of which some will receive either a placebo or dose of low, medium, or high levels of the drug injected directly into their eyes once a week over the course of a 4 week period.
High powered microscopes will be used to count the number of cells in the inner cornea before, during, and after the trial with the hopes that those receiving the drug will have more corneal cells than they did before the trial, and more than those on placebo. Participants will also undergo eye exams that are similar to those in an eye doctor’s office testing the ability to see letters with one eye.
The trial which is expected to take until the summer of 2021 to complete will also be monitoring for improvements, regression, and any possible side effects, safety, and how well it works. Costs for this trial will be covered from a $28 million financing round which was announced by the company in July of 2019.
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