Aspiera Medical has developed a new topical drug product (ointment) based on our patented technology (AMV405) with demonstrated antimicrobial and epithelialization (skin cell regeneration) activity. The AMV405 ointment is intended to act as a moisture barrier, actively reduce bioburden in wounds, and promote healing of wounds associated with rare skin disorders.
Our initial focus is on Epidermolysis Bullosa. We will begin our clinical research program in 2017 as part of our pathway to secure regulatory approval in the US, Europe and elsewhere for a new prescription drug.
Epidermolysis Bullosa (EB) is a group of rare, genetic skin diseases that cause the skin to become fragile, resulting in the formation of shearing, blisters, and lesions. There are currently no approved treatments for EB and skin lesions are treated with supportive, palliative care. Patients with EB present with varying degrees of severity. In less severe cases, patients have blisters and tears from only minor friction or trauma. More severe cases, those diagnosed at birth or shortly thereafter, suffer from lesions over large portions of their body surface area and can extend into the oral cavity and into internal organs of the body. The exposure of large surfaces can lead to infection, scarring, and death. These patients have a significantly reduced lifespan and experience tremendous levels of pain and discomfort. An estimated 30,000 to 40,000 patients are currently diagnosed with EB in the United States and the treatment cost for wound care is estimated to be well over $100,000 per year per patient. The major goals of wound dressings are to reduce water loss and prevent infection. Learn more about EB.
Please contact us if you have any questions about Aspiera’s investigational new drug.