Wisconsin Alumni Research Foundation

Stuart Therapeutics’ unique reparative tissue platform PolyCol™ provides much-needed relief for dry eye disease patients

Stuart Therapeutics was founded in 2018 to treat chronic eye diseases in new ways. That same year, the company licensed technology from WARF to develop the first of a series of drug candidates for dry eye disease, PolyCol™. PolyCol is made up of synthesized polypeptide sequences, or collagen mimetic peptides (CMP), designed to repair damaged extracellular matrix (ECM) helical collagen structures, which play a key role in healthy tissues. These synthetic peptide strings were developed by UW-Madison emeritus professor Ron Raines.

“Collagen plays an active role in tissue homeostasis and is found throughout the body,” says Stuart Therapeutics CEO Eric Schlumpf. “We saw it as having broad potential as a therapeutic approach.”

The eye’s surface has a layer of epithelial cells, but dry eye disease causes a disruption in the tear film, leading to damage to the cells and nerves that support them. Stuart Therapeutics’ working hypothesis is that CMPs repair damaged helical collagen structures and restore collagen’s healthy cell signaling behavior. This results in restoration of the epithelial cells and the nerves in the cornea. Stuart Therapeutics ran a Phase 2 clinical trial from October 2020 to October 2021 that showed promising results.

“The trial was successful; patients responded to the therapeutic quite well,” says Joshua Carson of WARF Ventures, who licensed the technology to Stuart Therapeutics in 2018 and participated in Stuart Therapeutics’ first round of financing in February 2020. “It was well tolerated, with almost zero side effects. Most dry eye drugs on the market, like anti-inflammatories, have moderately uncomfortable side effects, like stinging, and PolyCol does not.”

“The Phase 2 clinical trial for dry eye disease demonstrated broad effectiveness, based on the patient sample size of approximately 50 patients in the high dose cohort,” says Schlumpf. “We are discovering more and more about the drug and its mechanism of action as we compare our laboratory results with the trial data. It appears that we have a beneficial effect on the corneal nerves, which translates to patient improvement in visual function, reduction in symptoms, and increase in tear production. These are all very positive outcomes for dry eye patients.”

The company also has promising research results for glaucoma, with a drug that protects the optic nerve, rather than focusing on reducing intraocular pressure, as current treatments do. The company is working with the FDA to design a clinical trial that recognizes this new approach to the disease.

“We also plan to pursue two additional major indications in ophthalmology,” says Schlumpf. “Our initial research suggests that we have significant opportunities in retinal diseases, and we plan to pursue those, either ourselves, or with partners in development.”

The FDA has approved Stuart Therapeutics’ Phase 3 plans, including its trial endpoints, so the company has a roadmap for their next clinical trial. They are currently fundraising for capital for their Phase 3 trial.

“Stuart Therapeutics is pursuing a completely differentiated approach to the treatment of ophthalmic diseases,” says Schlumpf. “The company is constantly breaking new ground, with an opportunity to provide patients with a therapeutic approach that appears to work fast and effectively.”