This Company Says Its New Topical Therapy Trials Bringing Hope to People Exposed to Biofilm Bacteria

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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.

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

In New York, Hoth Therapeutics Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company focused on developing new-generation therapies for unmet medical needs, says it is making some great strides in its own clinical trials.

Hoth has announced it’s gained Human Research Ethics Committee (HREC) clearance to commence Cohort 2 of its Phase 1 clinical trial of BioLexa Lotion to treat mild to moderate atopic dermatitis (AD) in Australia. AD leads to significant emotional burden in addition to pain, physical discomfort, and sleep disturbance for 16.5 million adults in the U.S. alone.

BioLexa is Hoth’s patented, proprietary antimicrobial topical formulation being developed to treat diseases mediated by Staphylococcal biofilms. Mature bacterial biofilms often result in chronic, recurrent infections that are difficult to treat because of the barrier effect of the biofilm that facilitates antibiotic resistance and avoids immune system mechanisms.

“Receiving clearance for Cohort 2 is the next critical milestone in our Phase 1 clinical trial in Australia,”  Robb Knie, chairman, and CEO of Hoth Therapeutics said. “Management, our board, and scientific advisers believe that Hoth’s atopic dermatitis solution, BioLexa, represents a significant global opportunity, and we look forward to advancing the treatment through the clinic.”

“Unfortunately there's not a lot of therapeutics available right now in the pediatric and adolescent space for those suffering with atopic dermatitis. When you think of atopic dermatitis people think mainly of marks on their hands necks and so forth but it affects the face the eyes and it's also a mental issue as well because young children don't like to go to school if they're going to be made fun of because they have oozing or red marks and lesions on their face or body,” said Knie.

“BioLexa really helps with that. BioLexa is a combination therapy of two approved drugs that have been very well tested and tolerated for a long time in history.  The nice thing is that there's no corticosteroids involved. There's nothing on the market except for one drug right now that actually is approved to treat pediatric and adolescent patients that doesn't have a corticosteroid.”  

“The problem with this particular drug  is that it has very bad side effects of burning when you apply it so you can imagine if you have a young child and you put it on the first time and it burns - that child's not going to want to put it on again. So we think our trial that's going to take place in Australia will show great safety and efficacy and we're super excited about it.”

Improving Patient Outcomes

Hoth expects to start screening and enrolling the first subject(s) of Cohort 2 this year and report top-line data in the 1st quarter of 2022.

The Hoth BioLexa trial design includes:

• The study will be randomized, double-blind, parallel-design, and placebo-controlled.
• Cohort 2 includes adult patients in Cohort 2 with mild to moderate atopic dermatitis.
• The primary goal is to evaluate the safety and characterize the pharmacokinetics of topical BioLexa Lotion. 
• Participants are treated twice daily with the topical application directly on the skin for 14 days. 
• Preliminary efficacy will also be investigated in the atopic dermatitis patient cohort, including change in atopic dermatitis extent of involvement.

Hoth says that its development pipeline is currently improving patient quality of life for those suffering from indications, including atopic dermatitis, skin toxicities associated with cancer therapy, chronic wounds, psoriasis, asthma, acne, mast-cell derived cancers, and anaphylaxis, and pneumonia. Hoth has also entered into 2 different agreements to further the development of 2 therapeutic prospects to prevent or treat COVID-19. 

Learn more about Hoth Therapeutics at www.ir.hoththerapeutics.com/.

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.