A Fe3 Medical study has shown that its Fe3 patch successfully delivers iron through the skin.
The study was designed to test the safety and tolerability of Fe3’s iontophoretic transdermal technology that bypasses ionic resistance build up in the skin. The human study comes after a series of successful preclinical studies that demonstrated the safe delivery of iron through skin.
Iron deficiency anemia is a condition that can result in fatigue, poor cognition and motor function defects. Oral iron is the only therapy option, according to the company, but more than 45% of patients are unable to tolerate the effects of oral therapy because of side effects.
The Fe3 iontophoretic transdermal patch along with a generic iron compound could offer an alternative therapeutic option for patients who can’t take oral iron. The patch delivers therapeutic levels of iron without gastrointestinal side effects. The patch has also shown to significantly reduce adverse effects of traditional transdermal drug delivery like burns and skin discoloration.
A Texas Clinical Research Organization in Texas conducted the study under Investigational Review Board approval. Safety and tolerability were studied in 40 healthy volunteers.
The Fe3 patch was applied to the thigh of a subject after mild skin preparation. The patch was programmed with short hydration inverts followed by five hours of active therapy. Results showed that there was successful iron transport with a rapid rise in serum iron levels in the first four hours and a declined return to baseline within 24 hours. Iron transport increases based on dosage were also monitored, as well as transport rates.
There were no reported adverse effects and no scarring or long-term staining of the skin. Mild edema and erythema were resolved within three days.
“We are focused on bringing a new therapy option to the millions of patients suffering from iron deficiency anemia on a worldwide basis,” Mark Sieczkarek, CEO of Fe3 Medical, said in a press release. “Our first human study, along with our extensive preclinical studies, give us the confidence that our transdermal patch technology can effectively and safely deliver therapeutic levels of iron. We are now preparing for the next exciting phase for Fe3 and an upcoming clinical trial.”
The Fe3 patch was developed at InCube Labs. The first in-human tests were performed after successfully preclinical tests in pigs.
“The transdermal technology platform that Fe3 is based on is capable of delivering a broad range of molecules in a highly controlled fashion, which makes it a great platform for iron, as well as other drugs such as Diclofenac for pain and inflammation and Sumatriptan for migraines,” Mir Imran, chairman and CEO of InCube Labs, said.