Emerging Markets Report - Hoth Therapeutics on the Fast Track Toward Delivering Eczema Therapy Products to Market
ORLANDO, Fla., Dec. 13, 2019 (GLOBE NEWSWIRE) -- Nearly every person suffering from atopic dermatitis, more popularly known as “eczema,” knows just how difficult it can be to find effective remedies for his or her condition. Many prescription and over-the-counter treatments are not always consistent in providing relief, making new revolutionary improved topical medications a welcome addition to the narrow range of dermatological products dedicated to treating this difficult-to-cure ailment. Hoth Therapeutics, Inc. (NASDAQ:HOTH), is one such pharmaceutical company focused on providing eczema patients with a non corticosteriod therapeutic that actually helps treat eczema rather than just stop the itch.
BioLexa - A Competitive Advantage Among Its Industry Peers
Despite the relatively narrow regime of therapies for atopic dermatitis, solutions do abound, and any patient (as with any investor) would wonder what might make one solution better than another. HOTH’s answer to that question would point to its proprietary flagship product--the BioLexa Platform--a patented antimicrobial therapy based on cutting-edge scientific research from the University of Cincinnati.
So, what is it about BioLexa that differentiates it from other treatments? It’s one of the first and few drugs aimed at preventing rather than merely responding to eczema symptoms. Prevention versus response--two different approaches whose values can differ like night and day from the viewpoint of a patient.
How does it work? BioLexa combines an FDA-approved zinc chelator with antibiotics to prevent infectious “biofilms” from forming. By preventing the formation of biofilms, bacteria is rendered vulnerable to elimination by antibiotics. In addition to HOTH’s preventive approach, its BioLexa solution also has the unique capacity to target bacteria, differentiating it yet again from most other therapeutic products on the market, as the majority of treatments available are designed to address general factors--e.g. inflammation and immune-related conditions--in order to treat a condition that BioLexa targets directly.
Considering the aims toward preventive treatment and direct bacterial targeting, BioLexa-based therapies may prove a competitive advantage in a field where most products are by and large responsive and whose scope may be less direct. This potentially places HOTH in a unique industry position in a market that is projected to reach $28 billion in global spending by the end of 2019, according to .
The Road to FDA Approval
HOTH may seek FDA approval via the 505(B)(2) application process in order to reduce its products’ time-to-market. There are three regulatory pathways toward FDA approval. The 505(B)(1) pathway for new drug testing has a time frame ranging from 8-10 years. 505(j) for generic drugs takes between 1-2 years. The third, 505(B)(2), the pathway that HOTH may pursue, is a modified version of the 505(B)(1) that will enable HOTH to complete the regulatory process much faster, typically 3 years. HOTH plans on launching its clinical trials in humans in 2020.
New Developments and Licensing for Gene Therapy
As reported last September, HOTH had begun working with George Washington University to provide solutions countering the dermatological side effects that Erlotinib therapy may have on cancer patients. Recently, HOTH’s research and product capacity has been tapped for exploration into yet another field concerning dermatological ailments: gene therapy.
On November 26, 2019, HOTH announced a new licensing agreement with North Carolina State University to study the university’s “Exon Skipping Approach” for the treatment of allergic diseases. The Exon approach, developed by NC State professor Dr. Glenn Cruse, is a potential treatment approach based on RNA splicing. If executed according to design, this approach causes cells to “skip” the problematic sections of genetic code contributing to a patient’s allergic ailment. Though currently in development, this approach represents a potential breakthrough in the field of allergic diseases.
“This new collaboration will allow us to leverage this invention from the renowned expertise of Dr. Glenn Cruse and his scientific team at North Carolina State University. We look forward to seeing how their work advances and what this might mean for patients suffering from undesirable steroid side effects who need an alternate treatment for asthma and other allergic diseases,” said Robb Knie, HOTH’s Chief Executive Officer.
About Hoth Therapeutics, Inc.
Hoth Therapeutics, Inc. (NASDAQ: HOTH), (“HOTH” or the “Company”), is a biopharmaceutical company focused on developing new generation therapies for dermatological disorders including atopic dermatitis, chronic wounds, psoriasis and acne. For more information on their areas of research and product development, visit their website at .
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