Dr. Gregory D. Jay, owner of Lubris LLC, is celebrating his company’s licensing of lubricin as a clinically superior dry-eye treatment to Novartis, which will fund its development as an equally promising treatment for damaged joints and abdominal scarring prevention.
Lubricin, Jay explained, is a mucin – a glycoprotein found in the secretions of mucous membranes that helps make mucus slippery.
Lubris had previously licensed the production of the glycoprotein from Lifespan Corp., which funds Jay’s research.
Jay was pleasantly surprised when he realized lubricin could treat dry eyes. “That was not an indication that I was thinking of,” he said.
What Jay had in mind, rather, was lubricin’s lubricating qualities applied to osteoarthritis and joint injuries. As a lubricant, it can reduce friction of cartilage surfaces by restoring or supplementing lost mucin. As an anti-adhesive, it can protect organs from scarring after surgery.
But the dry-eye treatment will move a little faster through U.S. Food and Drug Administration approval, Jay said, because the eye is easily accessible for clinical trials. By comparison, “Joints are difficult to get into,” he said.
Peter Snyder, senior vice president and chief research officer at Lifespan, said about 25 percent of the proceeds from Novartis licensing lubricin will be directed to help fund research at Jay’s lab at Lifespan. That’s where he’ll work to ready human trials of lubricin as a treatment for joints.
Jay has been focused on biotribology – the study of friction and wear in the body – from the beginning of his career in 1985 at Stony Brook University’s School of Medicine, where he focused his thesis project on lubricin.
“I kept studying it,” Jay said, after taking a professorship at Brown University’s Warren Alpert Medical School in 1993. He’s since become a professor in both the department of emergency medicine and department of engineering.
Jay kept studying the protein while working for University Emergency Medicine Foundation as an emergency doctor, practicing at Rhode Island Hospital and The Miriam Hospital. Recent developments in his work include a comparison of lubricin to hyaluronic acid, another common substance in the body, used to treat dry eyes.
Published in the journal Ocular Surface in January 2017, the study showed lubricin was 71 percent better than hyaluronic acid on subjective tests relieving dry or irritated eyes, as well as in objective tests such as blink time.
The key to marketing lubricin was breeding a type of cell that could produce the protein without dying, Jay said.
“This is not an easy protein to make,” he said. Lubricin was toxic to the cells typically used to make it, which was a commercial disadvantage. But he was able to breed a line of cells that could produce lubricin in commercial quantities, which was a crucial step in gaining the interest of a drug company such as Novartis.
In 2010, Jay conducted a study with Braden Fleming of the Center of Biomedical Research Excellence for Skeletal Health and Repair at Rhode Island Hospital that proved the ability of lubricin to restore lubrication and slow cartilage loss in the joints of rats due to trauma or surgery.
Lubricin, Jay said, can address the problem causing the pain – excess friction in the joint.
‘Lubricin appears to delay or prevent osteoarthritis.’
DR. GREGORY D. JAY, Lubris LLC owner
“Lubricin appears to delay or prevent osteoarthritis that comes from trauma, injury or even the wear and tear of aging. We know that the inflammation process erodes cartilage; lubricin protects it and encourages natural lubricin to be expressed,” Jay said. “This could have as significant an impact on protecting joints [as] the effect that a dental sealant has when protecting teeth.”
The protein has also been shown to prevent scarring after abdominal surgery, Jay said. Scarring inside the abdomen after surgery is a serious and common medical concern, he said, contributing to increased complications and deaths.
Lubricin, according to a July 2016 study in the medical journal Elsevier, reduced lesions inside the abdomens of rats after surgery.
While Lifespan has invested in Jay’s research by providing lab space, administrative and regulatory support, and aided him in securing the patent, it can’t directly market lubricin, given the hospital system’s nonprofit status.
“We would be remiss if we didn’t try to get it out on the market,” Snyder said.
So, Lifespan licensed the material rights to lubricin and the method rights to apply it for orthopedic use to Tribos LLC in 2008. Tribos later merged with Singularis in 2011, which possessed the ophthalmic rights, and the new company, Lubris LLC, licensed it to Novartis, according to Harry Barnett, co-founder and executive chairman of Lubris.
Lifespan recognizes there’s a potential conflict of interest, Snyder said, so it’s important to monitor Jay’s research closely, to ensure no one is tampering with it to speed lubricin to market prematurely. Also, the clinical trials for lubricin are being conducted in a lab outside of Lifespan’s network. “So, we will intentionally not be involved,” Snyder said.
Lifespan’s research investments have resulted in many patents, Snyder said, but they don’t all show the commercial potential of lubricin.
“And now we have a first, big commercial hit,” Snyder said.
