DUR-928 compound continues phase 1 clinical trials

May 19, 2015 by Eric Peters, Virginia Commonwealth University

A therapeutic compound developed at Virginia Commonwealth University, which may have broad applicability in acute organ injuries and in several metabolic diseases such as nonalcoholic fatty liver disease and nonalcoholic steatohepatitis, continues to make strides toward becoming an approved treatment option.

A phase 1 oral single-dose study was completed earlier this year. In March, DURECT Corporation announced it had initiated an oral multidose phase 1 clinical trial. Phase 2 is scheduled to begin next year.

The compound, DUR-928, is the result of a collaborative effort between the VCU Department of Internal Medicine, VCU Medical Center and the McGuire VA Medical Center. DURECT Corporation has helped develop the compound and holds the rights to commercialize DUR-928 and related molecules discovered during the collaboration.

Shunlin Ren, M.D., Ph.D., associate professor in the VCU School of Medicine, has carried out nearly 20 years of discovery research leading to DUR-928.

"This novel regulator has a potential to serve as a novel therapeutic for acute organ injury and chronic metabolic/lipid disorders, and ultimately to save many patients' lives," he said.

DUR-928, an endogenous epigenomic regulator, is an orally bioavailable small molecule that modulates the activity of various nuclear receptors that play an important regulatory role in lipid homeostasis, inflammation and cell survival.

The first phase 1 trial of DUR-928 was a single-site, randomized, double-blinded, placebo-controlled, single-ascending-dose study that evaluated the safety, tolerability and pharmacokinetics of DUR-928 when orally administered. The 30-subject study evaluated DUR-928 in five cohorts of healthy volunteers receiving DUR-928 (up to 1,000 mg dose).

DUR-928 was well-tolerated at all dose levels, with no treatment-related adverse events reported and no subjects withdrawing from the study.

VCU Innovation Gateway has been an essential component in DUR-928's development. Acting as a liaison to outside companies, Innovation Gateway is a university resource that facilitates commercialization of university inventions and supports research through collaborative agreements.

"The relationship with DURECT is a telling example of our strategy for building strategic industry partnerships," said Ivelina Metcheva, Ph.D. "These connections lead to sponsored research and eventually licensing to enable commercialization of intellectual property at VCU."

DURECT anticipates commencing a phase 1 single-dose, injectable administration trial in healthy subjects in the second half of 2015 as precursor to a multidose phase 1 trial. Assuming no undue safety results from these trials, DURECT would then be positioned to commence one or more phase 2 trials with patients in 2016.

DURECT is evaluating various potential indications for DUR-928 in order to prioritize the development program. Long-term opportunities fall into four broad categories: (a) acute orphan indications, (b) broader acute indications, (c) chronic orphan indications, and (d) broader chronic indications. DURECT's initial phase 2 studies will be designed to show an efficacy signal in patients suffering from an acute orphan condition such as acute kidney injury and a chronic indication such as or one of the orphan liver conditions DURECT is exploring.

"We are very excited about the results of this research," Ren said. "We are constantly finding new clinical applications for DUR-928 and look forward to announcing successful clinical trials for those applications. I hope FDA's future approvals of DUR-928 will give new hope to patients with cardiovascular, liver, kidney and other diseases. It is exciting to have the opportunity to help people and save lives."

Explore further: Another step toward sickle cell disease treatment

Related Stories

Another step toward sickle cell disease treatment

July 10, 2014
(Medical Xpress)—A compound discovered at Virginia Commonwealth University has taken yet another step closer to becoming the only approved drug in the world that is therapeutically effective in managing adult sickle cell ...

Research leads to possible new treatment for sickle cell disease

September 23, 2013
There's a new ray of hope for those battling sickle cell disease thanks to a compound that was discovered at Virginia Commonwealth University.

MassBiologics receives orphan drug status from FDA for hepatitis C treatment

December 4, 2013
MassBiologics of the University of Massachusetts Medical School (UMMS) has received an orphan drug designation from the U.S. Food and Drug Administration (FDA) for MBL-HCV1, a monoclonal antibody developed to prevent hepatitis ...

Researchers identify changes in cholesterol metabolic pathways

June 7, 2012
A new study from the Virginia Commonwealth University School of Medicine has identified molecular changes responsible for abnormal cholesterol production and metabolism in the livers of patients with a common liver condition, ...

Diabetes drug shows promise in the treatment of non-alcoholic steatohepatitis

April 23, 2015
A drug approved to treat type 2 diabetes could prove to be a powerful new treatment option for non-alcoholic steatohepatitis (NASH), according to research presented today at The International Liver Congress 2015. Results ...

Mouth, as well as gut, could hold key to liver disease flare-ups

April 17, 2015
In a recent study, Virginia Commonwealth University School of Medicine researchers predicted which cirrhosis patients would suffer inflammations and require hospitalization by analyzing their saliva, revealing a new target ...

Recommended for you

Researchers publish study on new therapy to treat opioid use disorder

May 22, 2018
Better delivery of medications to treat opioid use disorder (OUD) is key to addressing the opioid crisis and helping the 2.6 million Americans affected by the disease.

Could nonprofit drug companies cut sky-high prices?

May 17, 2018
(HealthDay)—Generic prescription drugs should be cheap, but prices for some have soared in the United States in recent years. Now a group of U.S. hospitals thinks it has a solution: a nonprofit drug maker.

Fewer antibiotics for kids, but more ADHD drugs

May 15, 2018
(HealthDay)—American kids are taking fewer prescription medications these days—but certain drugs are being prescribed more than ever, a new government study finds.

Opioid makers' perks to docs tied to more prescriptions

May 14, 2018
Doctors who accept perks from companies that make opioid painkillers are more likely to prescribe the drugs for their patients, new research suggests.

Less is more when it comes to prescription opioids for hospital patients, study finds

May 14, 2018
In a pilot study published in JAMA Internal Medicine, Yale researchers significantly reduced doses of opioid painkillers given to hospital patients. By delivering the opioids with a shot under the skin or with a pill instead ...

Generic options provide limited savings for expensive drugs

May 7, 2018
Generic drug options did not reduce prices paid for the cancer therapy imatinib (Gleevec), according to a Health Affairs study released today in its May issue.


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.