The Changing Landscape in Chronic Diabetic Foot Ulcers

The Changing Landscape in Chronic Diabetic Foot Ulcers

While the market of treating chronic diabetic foot ulcers is by no means glamorous, it can still be a very lucrative indication. Some estimates have put the chronic diabetic foot ulcer market at $2 billion annually by 2017. With so much money hanging in the balance, companies are taking notice and attempting to develop better treatments.

One of the companies attempting to develop a better treatment for chronic diabetic foot ulcers is Osiris Therapeutics . Earlier this month, Osiris shares more than doubled as the company announced positive data for its CDFU drug Grafix. The study results were very impressive to say the least; the study was stopped early due to the overwhelming efficacy exhibited by the treatment. A main highlight is the fact that 62% of Grafix patients had their wound closed at 12 weeks, compared to only 21% of patients using conventional methods. Clearly, the efficacy in this endpoint was overwhelming. Grafix also achieved all of the secondary endpoints for the trial, and more importantly demonstrated a relatively benign safety record.

Grafix has raised the bar on chronic diabetic foot ulcer treatment. Another company developing treatments for CDFU is Derma Sciences . Derma is developing a treatment called DSC 127, which is currently in phase 3 trials with results expected in 2015.

With this in mind, quickly comparing the data it appears as though Osiris may have just trumped Derma's treatment. In Derma's phase 2 study, it announced that 54% of patients in its intent to treat group experienced wound closure, compared to 33% in the control group at 12 weeks. Now, Derma's study was a 24-week study, and at week 24, 73.1% of patients using DSC 127 experienced complete wound closure, compared to 48.5% in the control group. Taking into account the data currently available, it appears as though Osiris may have the more effective treatment of the two. However, it will be interesting to see what happens when Derma ultimately comes out with its phase 3 data.

The market for the treatment of chronic diabetic foot ulcers has been growing and larger companies have been taking notice. Many large pharmaceutical companies have their own treatments for chronic diabetic foot ulcers. The space has also caused some major acquisitions. In 2011, Shire acquired a drug called Dermagraft for the treatment of slow-healing diabetic foot ulcers, through its $750 million acquisition of Advanced BioHealing. Dermagraft has been a rather lucrative product for Shire, with $153.8 million in sales last year. As the market continues to grow, I would look for more partnerships with large pharmaceutical companies, and of course more research and development dollars being devoted toward the chronic diabetic foot ulcers indication.

There are, of course, many other treatments for chronic diabetic foot ulcers. The treatment options are progressing all of the time, and more companies are entering with the hopes of creating a bigger and better treatment for CDFU. It seems as though Osiris' Graft may be the temporary favorite for investors in this space right now. Whether it will remain that way, only time will tell. However, the recent data should be rather concerning for Derma, and investors will be watching carefully when Derma ultimately releases its clinical trial results.

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