Copyright 2017 Hoth Therapeutics, Inc.
Hoth Therapeutics Inc. is a development stage biopharmaceutical company focused on unique targeted therapeutics for patients suffering from indications such as atopic dermatitis.
Hoth’s first focus to market therapeutics will be the Biolexa compound, a treatment for atopic dermatitis, also known as eczema. BioLexa combines two (2) FDA approved drugs in a proprietary formulation to prevent bacterial proliferation, colonization, and biofilm-related infections.
Eczema is a disease which causes the inflammation or irritation of the skin. Eczema impacts approximately 35 million Americans and represents a $9.5 billion market in the U.S. alone. Biolexa’s platform can also be used as a therapeutic in aesthetic dermatology, by reducing post-procedure infections and accelerating healing. With over eight (8) million aesthetic dermatological procedures a year in the U.S., the U.S. market for Biolexa is estimated at $2 billion for this application.
Biolexa has achieved positive results in its initial studies conducted at the University of Miami. In addition, Biolexa has the advantage of a shorter-than-average FDA approval process, with the ability to start Phase 2 FDA testing under the 505(b)(2) regulatory pathway. This may result in lower development costs and shorter development time. Under 505(b)(2), testing time is often 66% to 75% less than for a new drug.