A 2013 Mayo Clinic study involving more than 140,000 patients revealed that skin disorders are the most common nonacute reason Americans seek health care. Topical corticosteroids, available since the 1950s, are the most prescribed dermatologic drugs and the mainstay of treatment for many conditions. According to IMS Health, which tracks prescribing data, the total number of U.S. retail prescriptions for steroids rose from 171.3 million in 2007 to 207.6 million in 2012, with topical steroids accounting for 39 million prescriptions.
One man with a stark view of this trend is Gur Roshwalb, M.D., Chief Executive Officer of Celsus Therapeutics, a drug development company focusing on novel non-steroidal anti-inflammatory, first-in-class synthetic drugs termed Multi-Functional Anti-Inflammatory Drugs (MFAIDs). According to Dr. Roshwalb, prolonged use of steroids can lead to undesirable side effects such as tachyphylaxis (tolerance to vasoconstriction), rosacea, stretch marks and skin atrophy. In addition, short stature and suppression of the hypothalamic-pituitary-adrenal axis in children remain concerns for both physicians and patients. Long-term steroid use can also promote the development of infections. To counter the limitations of steroid treatment, some physicians have prescribed calcineurin inhibitors, which in turn carry a cancer risk and can suppress the immune system.
Dr. Roshwalb's concerns are echoed by the National Eczema Association, which notes that frequent and prolonged application of a topical corticosteroid to the eyelids, for example, can cause glaucoma and even cataracts; acne around the mouth; and redness around hair follicles.
Dr. Roshwalb's determination to develop alternatives to topical corticosteroids is made possible by his own background and the work he is currently doing at Celsus. Prior to entering the business world, Dr. Roshwalb was in private practice in New York City and board certified in internal medicine. He received his M.D. from Albert Einstein College of Medicine and trained in internal medicine at the Mount Sinai Medical Center, where he also served as Chief Resident in 1997-1998.
Celsus' MFAIDs are designed to block a key enzyme that triggers inflammation. The company's lead drug candidate, MRX-6, is a topical cream currently being tested in a Phase II trial in atopic dermatitis, with results expected during the fourth quarter of 2014. A previous trial of MRX-6 showed significant improvement in patients with contact dermatitis. Celsus believes MRX-6 and other MFAIDs it's developing might offer effective treatment for a wide range of inflammatory diseases—not only in dermatitis but also in pulmonary inflammation like cystic fibrosis, inflammatory bowel disease and conjunctivitis.
If the work at Celsus comes to fruition, it could be the beginning of a new set of options for patients experiencing various types of inflammation—and one that avoids the very real risks presented by today's steroids.
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