Israel’s Foamix recently began a Phase II clinical trial (efficacy and safety) of its Topical Minocycline Foam for patients suffering from Rosacea, a chronic condition characterized by facial redness.
While there is no cure for Rosacea, patients usually turn to one of the numerous pharmaceutical companies offering Minocycline in oral form. At the moment, there is no product on the market for delivering the drug through the skin.
“There is a huge demand for new safe and effective topical treatments for Rosacea.” said Dov Tamarkin, CEO of Foamix. “Based on its pharmacological profile, Topical Minocycline represents a strong alternative to the existing topical Rosacea drugs. The initiation of our Phase 2 trial is a significant achievement for Foamix. Not only does it represent a development accomplishment in terms of product stability, but it is an important step in our strategy of taking our drugs into advanced development phases.”
Foamix said that in laboratory studies it effectively killed various bacteria that cause acne, and that transdermal delivery of the product was sufficient to treat the disease, without penetrating too deep to reach the bloodstream. The clinical trial is being conducted according to US Food and Drug Administration (FDA) protocols, but not under FDA inspection.
The cause of Rosacea is unknown. According the American National Rosacea Society, more than 16 million Americans are affected by this condition. And, surveys show that a high percentage of patients also suffer lower self-esteem and self-confidence because of their condition.
Foamix said its new product can also treat regular acne, skin inflammations, and chronic wounds, as well as Rosacea. The company plans to continue development of the product independently, in contrast to other products which it is developing jointly with other drug companies.
“We are preparing to invest what is needed to bring the product to market independently,” said Foamix CEO Tamarkin. “We’re not trying at the moment to sell the rights to it to another company. If we get the right offer, we’ll be very happy.”
As will the millions of Rosacea sufferers across the globe.