OUR TECHNOLOGY IS BASED ON CUTTING-EDGE SCIENTIFIC RESEARCH FROM THE UNIVERSITY OF CINCINNATI.
Hoth Therapeutics is a development stage biopharmaceutical company focused on proprietary therapeutics for patients suffering from indications such as atopic dermatitis, also known as eczema. To treat indications impacting more than 32 million Americans, Hoth is working to develop and commercialize the BioLexa™ Platform, a proprietary, patented, drug compound platform developed at the University of Cincinnati. The BioLexa Platform has achieved positive results at preclinical studies conducted at the University of Miami.
Hoth Therapeutics is a development-stage biopharmaceutical company focused on unique targeted therapeutics for patients suffering from indications such as atopic dermatitis, also known as eczema.
Hoth owns the exclusive rights to develop the BioLexa PlatformTM for all indications in humans. The BioLexa PlatformTM is a proprietary, patented, drug compound platform developed at the University of Cincinnati. The BioLexa PlatformTM combines an FDA-approved zinc chelator with one or more approved antibiotics in a topical dosage form to address unchecked eczema flare-ups by preventing the formation of infectious biofilms and the resulting clogging of sweat ducts. It is the first product candidate intended to prevent the symptom-triggering flare-ups rather than simply treating symptoms after they occur.
We intend to explore the use of the BioLexa PlatformTM for the treatment of atopic dermatitis, or eczema.
We also intend to explore the use of the BioLexa PlatformTM in the aesthetic dermatology field to help treat and reduce post-procedure infections, accelerate healing and improve clinical outcomes for patients undergoing procedures. We believe that the BioLexa PlatformTM’s ability to fight bacterial growth will enable the innate immune system to focus on optimal healing rather than fighting post-procedure infection.
Finally, we intend to explore the use of the BioLexa PlatformTM in connection with diabetic foot ulcers. We believe that the BioLexa PlatformTM‘s ability to fight bacterial growth will help initiate and/or improve chronic diabetic wound healing as well as accelerate the healing of diabetic wounds with S. aureus.
Hoth has also licensed exclusive rights to certain patented technology from the University of Cincinnati for use in determining the risk that a patient will develop allergies to peanuts, milk and other foods as well as predict propensity for eczema. Hoth’s overall goal is to develop and make ready for commercialization a family of genetic screening tests based on the licensed technology.
The BioLexa Platform is a proprietary, patented antimicrobial therapy.
The Platform is based on cutting-edge scientific research from Univ. of Cincinnati (PNAS 2008, PNAS 2013, Biochemical J. 2017, Protein Science 2017).
Centers for Disease Control data indicates that “biofilms” are implicated in over 2/3 of all skin infections. Biofilms are specialized bacterial colonies that are resistant to antibiotics and immune system responses. Moreover, staph bacteria require zinc to form the biofilms that allow the bacterial colonies to grow and resist treatment.
The BioLexa Platform is a synergistic combination of a zinc chelator and an antibiotic that prevents biofilms from forming, leaving the bacteria susceptible to elimination by the antibiotic.
BACTERIAL BIOFILMS: A MAJOR CHALLENGE
Biofilms are specialized colonies of bacteria that adhere to a surface and to one another. The bacteria growing in a biofilm are highly resistant to antibiotics and immune responses. As a result staph biofilms cause recurrent, hard to treat infections.
ZINC & STAPH BIOFILMS
Zinc is required for the formation of staph biofilms
The Staph biofilms form when thread-like thread-like proteins (Aap or SasG) on the bacterial surface stick to one another holding the cells together. The Herr Lab, run by Dr. Andrew Herr at the University of Cincinnati discovered that these proteins only become adhesive when exposed to zinc ions.
The BioLexa Platform traps all the zinc ions by adding a chelator called DTPA, which prevents Staph biofilm formation. In pre-clinical testing on animals, the BioLexa Platform showed impactful results.
HOTH THERAPEUTICS INTENDS TO PURSUE A 505(B)(2) REGULATORY PATHWAY.
The FDA allows some of the safety and efficacy information on active ingredients(s) to come from studies not conducted by Hoth. Because Hoth can rely on the historical data, we should have a much shorter time and cost to get BioLexa FDA approved, as compared to standard 505(B)(1) approval.