The two-year grant will be utilized for RegeneRx’ phase II clinical trial, which is currently enrolling patients.
Epidermolysis bullosa (EB) is a rare, often devastating, genetic disease that has been designated an orphan indication by the FDA. EB is characterized by the presence of extremely fragile skin and recurrent blister formation resulting from minor mechanical friction or trauma often associated with routine daily activity. These blisters develop into chronic, raw wounds that can also occur in the eye, mouth, and internal organs and tissues.
Patients with the most severe form of EB produce less laminin-5, a protein that induces both adhesion and migration in a wide variety of cell types. Laminin-5 plays a key role in maintaining the structural integrity of the skin and is a vital protein needed for proper healing of wounds. In addition to accelerating wound healing, thymosin beta 4 (TB4), on which RegeneRx’ drug candidate is based, has been shown to increase the production of laminin-5.
“We are very pleased to receive this grant from the FDA,” noted commented J Finkelstein, RegeneRx’ president and CEO. “There is no drug currently approved to accelerate wound healing in EB patients and it is our goal to address this need.”