Fe3 Medical completes first human study of electric transdermal iron patch

Tests showed rapid rises in serum iron levels during the first four hours of treatment, with a decline and return to baseline levels within 24 hours. (Pixabay)

For many people with Crohn’s disease, inflammatory bowel disease or gastric bypass operations, it can be hard to maintain sufficient levels of iron in the bloodstream. That can be harder still when oral iron pills can cause intolerable nausea, constipation and diarrhea.

But now, Fe3 Medical is moving forward with its wearable patch that uses electrical current to deliver iron directly through the skin to treat one of the world’s most common deficiencies.

The company’s first human study found its iontophoretic platform was able to safely deliver the generic mineral in 40 healthy volunteers. After a skin preparation, Fe3’s transdermal patch was applied to the thigh and programmed for a short hydration period followed by about five hours of active therapy.

Webinar

How ICON, Lotus, and Bioforum are Improving Study Efficiency with a Modern EDC

CROs are often at the forefront of adopting new technologies to make clinical trials more efficient. Hear how ICON, Lotus Clinical Research, and Bioforum are speeding database builds and automating reporting tasks for data management.

RELATED: Texas bumps up Fe3 Series B to $14.5M to get anemia patch approvals

Tests showed rapid rises in serum iron levels during the first four hours of treatment, with a decline and return to baseline levels within 24 hours. Dose-dependent increases in iron transport were also seen, the company said, while no major adverse effects were reported such as scarring or long-term staining of the skin.

The transdermal patch (Fe3 Medical)

“We are focused on bringing a new therapy option to the millions of patients suffering from iron deficiency anemia on a worldwide basis,” CEO Mark Sieczkarek said in a statement, adding that the company is preparing to launch an additional clinical trial.

RELATED: Life sciences VC firm launches 'crowdfunding' site for limited crowd

The patch’s design was developed at InCube Labs, a life sciences R&D lab founded by Mir Imran, who serves as Fe3’s board chairman.

“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,” Imran said.

Suggested Articles

Pfizer’s 2017 spinout company SpringWorks has lost president and founder Lara Sullivan, M.D., who has moved over to Pyxis Oncology as its new chief.

The drug, Compass Pathways’ COMP360, came through the placebo-controlled phase 1 without setting off any safety alarms.

Kite hopes to win approval for KTE-X19 in mantle cell lymphoma on the strength of midphase results linking it to a 67% complete response rate.