A startup company founded by Dong Wang, PhD, professor in the UNMC College of Pharmacy, has been awarded a fast-track Small Business Innovation and Research grant of nearly $2 million for a potentially transformative new treatment for arthritis.
The initial Phase I National Institute on Drug Abuse award of $250,000 supported a proof of concept study, which was successfully completed last year. The $1.68 million Phase II funding was approved on Jan. 5, 2021. It will support a series of pre-clinical studies that are designed to open the door to filing an investigational new drug application with the FDA.
"This will prepare us for talking to the FDA about the design and implementation of a clinical trial to test the safety and effectiveness of the new drug," Dr. Wang said.
"We're really lucky because the rheumatology and orthopaedic programs at UNMC are world-class and have established the Nebraska Arthritis Outcomes Research Center, which has the personnel and expertise to conduct the clinical trials. The campus will be an ideal place to initiate the clinical studies."
Dr. Wang founded Ensign Pharmaceutical on a novel formulation called ProGel, which is an injectable liquid. After ProGel is injected, it transforms into a gel-like substance as it reaches body temperature. The gel is then more likely to linger in the affected area, concentrating the pharmaceutical payload exactly where it needs to be.
Any number of pharmaceuticals can be combined with ProGel, making it a "platform technology." Platform technologies like ProGel can be used for localized and sustained delivery of a variety of therapeutic agents to treat a broad spectrum of clinical conditions.
Ensign's first product will incorporate a potent steroid, dexamethasone, into the ProGel formulation. The Phase II study will identify the optimal formulation, and evaluate its long-term efficacy in the treatment of arthritic joint pain.
Dexamethasone is a synthetic version of an anti-inflammatory steroid normally produced by the human adrenal gland. It is a common treatment for lupus, asthma and many other inflammatory diseases, and has gained recent notoriety for its potential in fighting the COVID-19 pandemic. When injected into a joint, dexamethasone provides temporary relief of debilitating pain and swelling caused by osteoarthritis, a chronic condition that slowly erodes the protective cartilage at the end of bones.
While effective for pain relief, the benefit of dexamethasone is unfortunately short-lived, usually lasting only a few days. However, when formulated with Dr. Wang's ProGel, dexamethasone has the potential to remain active much longer, potentially providing relief for months.
"In mouse models of osteoarthritis, ProGel has shown effective pain relief for at least four months," Dr. Wang said, "but a mouse is very, very different than a human being . . . These new experiments will help us to better predict how it may work in humans, and to optimize the drug design to provide similar sustained pain relief in humans."
Congratulations, Dr. Wang! There are lots of clinical potential of your ProGel.
Congratulations! Wonderful news!
Such a great news! Proud to be a member of Dr. Wang’s group.
Way to go, Dong!
Congratulations Dr. Wang & wishing you continued success in your company & studies!
Congratulations Dr Wang!
Congratulations, Dr. Wang !
Great news! Congratulations!!
Great news for those with arthritis! Congratulations!
Such a kind man and wonderful scientist. Congratulations, Dr. Wang!
Congratulations Dr. Wang !
Congratulations Dr. Wang and lab!
Well done Prof. Wang - this is great news!!
Congratulations! Great hope for those of us who suffer from arthritis!
Congrats Dong and much success with the company.