Early Clinical Data Suggest This New Lotion Could Offer Best-In-Class Eczema Treatment and Infection Prevention, According to Hoth Therapeutics

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The following post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga.

More than 31 million Americans suffer from some form of eczema. Another 6.5 million suffer from chronic wounds — slow-to-heal wounds that put patients at high risk of infection and loss of limbs. Meanwhile, approximately 300,000 patients per year in the United States suffer from surgical site infections, costing anywhere from $3.5 billion to $10 billion per year to treat. 

What all of these patients have in common is a need for a rapid, effective treatment that can target infections before they spread and, more importantly, before they become resistant to standard antibiotics.   

That’s what Hoth Therapeutics Inc. HOTH is hoping to offer with its new patented topical formula that breaks through one of the strongest defenses bacteria have to provide rapid relief and prevent worsening infections. The proprietary BioLexa Platform just entered Phase 1a/2b clinical trials this year and, if approved, could become one of the most effective treatments for each of the indications mentioned earlier. 

BioLexa Platform Breaks Through Major Barrier to Treating Skin Infections?

The advantage that the BioLexa Platform would offer is a unique formula that blends 2 compounds already approved by the Food and Drug Administration (FDA) that can break through one of the most difficult roadblocks making these skin conditions so difficult to treat: biofilms.

Biofilms are a kind of sticky surface layer that Staphylococcus colonies form to protect themselves from both the body’s immune system response and antibiotics. While safely hidden inside this biofilm, bacterial infections are difficult for the body to fight and difficult for doctors to treat. 

Hoth states that the BioLexa Platform includes a zinc chelator that deprives bacteria of the zinc they need to form the biofilm and then follows that up with an antibiotic that quickly wipes out the vulnerable bacteria. Early preclinical and clinical results of the potent compound have shown the potential to reduce bacteria growth and stop them from forming difficult-to-penetrate biofilms more effectively than either of the ingredients on their own. 

When Could BioLexa Reach the Market?

The FDA requires each new treatment to go through a 4-phase development spanning discovery and development, preclinical research, clinical research, and FDA review before reaching markets.

After years in development and preclinical research, Hoth started Phase 1b/2a clinical trials for the proprietary formula earlier this year, putting it in the early stages of the 3rd phase of the FDA approval process. These human clinical trials are already underway and typically last anywhere from a few months to 2 years and involve up to 3,000 volunteer subjects. Another 1 to 4 years is needed for larger phase 4 clinical trials spanning several thousand subjects. Finally, the FDA review can last anywhere from a couple of months to 2 years. 

Given this process, the BioLexa platform is still a few years away from reaching consumers, but Hoth states that the treatment’s potential to address unmet needs in large markets combined with preliminary results are aligning to create a positive outlook.

From Unilever ULVR and AbbVie ABBV to Amgen AMGN and Biogen BIIB, biopharmaceutical companies are looking to develop topical treatments to combat the effects of bacterial biofilm. 

The preceding post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga. Although the piece is not and should not be construed as editorial content, the sponsored content team works to ensure that any and all information contained within is true and accurate to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.