Recently, important news was released regarding the preliminary results of a Phase II study of a recombinant human protein drug (FGF-18) targeting cartilage growth in people with osteoarthritis. This study marks the very first time that an investigational drug showed the ability to increase cartilage instead of stopping or slowing its decline. If further research regarding this drug proves to be fruitful, this could have huge implications for the millions of men and women who are currently struggling to manage and live with painful and stiff joints caused by arthritis and other similar conditions.
Promising Preliminary Findings
The results of this study come from an efficacy assessment taking place two years into a five-year study. They showed an average 0.05 mm increase of joint cartilage at the highest dose of the drug, which appears to be clinically meaningful. Importantly, the results also showed that a 0.04 mm cartilage increase could be achieved at a lower dose, which strongly suggests a dose-dependent effect, something that is truly meaningful in the world of drug development.
What Do These Findings Imply for Arthritis Sufferers?
Unfortunately, there was no reported benefit for either pain or function compared to a placebo, so the exact meaning of these findings is still vague and will therefore require further research to determine. Apparently, subjects receiving the placebo reported the same improvement in this assessment as subjects receiving the drug, so reading between the lines, it would seem that there might be a pain and a function benefit of some yet-to-be-determined magnitude.
What does this mean to those of us who experience the pain and reduced mobility of arthritis? It is still hard to say for sure. The study is not complete, and there are still Phase III studies to be performed. Although the length and size of those studies are completely unknown, we can be pretty confident that the FDA will want a large number of subjects to be involved in order to assess the safety of the new drug. After the debacle that was Vioxx, where as many as 60,000 Vioxx users died years after approval due to latent cardiac events, the FDA is unlikely to be sanguine or understanding of a less-than-acceptable drug safety report (Forbes Magazine).
Critical markers of disease progression, such as inflammation, were not reported in this mid-study update, but will speak volumes about how the body is responding to the drug. I am eagerly awaiting the results of Phase III of this study, along with continued preliminary releases of important data pertaining to the drug’s effects on pain and function.
I personally hope that this drug proves to be successful and becomes a safe alternative for treating and living with arthritis. Sooner or later, millions of Americans will look to Medicare to replace their worn-out, painful joints. In the meantime, I will continue applying Enduras Recovery Cream three times each day, as I have been for some time now. In fact, I completed the 165-mile Tahoe Rim Trail hike in September, and, in the process, crossed over the total of hiking more than 400 miles in the mountains this summer! And I did it pain-free! My personal view is that I undoubtedly owe this all to Enduras.
At the end of the day, my core view stays the same: Chronic disease requires chronic treatment. I intend to continue living independently and pain-free, with the help of Enduras.
About the Authors
William Goolsbee has spent his career in Life Sciences including leading roles in drug development in immunology and genetic medicine. Recent senior positions include Chairman of the Board at Sarepta Therapeutics and Founder and CEO at Metrodora Therapeutics.
Dr. Gil Price
Gil Price M.D. is the Chief Medical Officer at the Propharma Group, where he provides medical supervision for all clinical trials. He previously served as the Chief Executive Officer of Drug Safety Solutions, where he oversaw safety monitoring for drugs in clinical development. Dr. Price also served as the Director of Clinical Development at Medimmune Oncology and Director of Medical Affairs at Glaxo.