Hoth Therapeutics, Inc. (NasdaqCM: HOTH) is an innovative biopharmaceutical company that is targeting the market potential from the more than 32 million patients, in the United States alone, that suffer from atopic dermatitis, dermatological disorders, chronic wounds, and surgical site infections. By leveraging its proprietary and globally licensed BioLexa Platform, HOTH is leveraging potential best-in-class results from studies conducted at both the University of Cincinnati and the University of Miami’s, Miller School of Medicine, to take advantage of a market that already eclipses a $7 billion opportunity.
Now powered by its licensing deal with the University of Cincinnati to utilize the innovative BioLexa Platform, HOTH is intending to challenge the current multi-billion dollar market opportunities and is well-positioned to capitalize on the markets expected growth, which is estimated to become a $23 billion combined dermatological disorders market by the year 2023.
The Power of Zinc, And How The BioLexa Platform Uses It
Fresh off of its IPO in February, which raised roughly $7 million, HOTH is demonstrating potential best-in-class ability highlighted by its most recently published results from studies using the BioLexa Platform. In two university studies, the BioLexa Platform has shown an ability to target a primary cause of severe infection, “biofilms,” which the Centers for Disease Control indicate are implicated in more than two-thirds of all skin infections. These biofilms often serve as the culprit to the healing process by providing the bacteria the environment to develop into functional bacterial colonies that are highly resistant to both antibiotics and natural immune responses. Put simply, these biofilms act as a protective layer of support for the infection that inhibits effective treatment, and not only provides the colonies with the optimal conditions for bacterial growth but makes the indication extremely hard to treat.
What HOTH has discovered, though, is that a primary asset to the growth of staph infection is zinc, and HOTH is now targeting that essential element to reduce its effectiveness to defend against bacteria growth and treatment. Now, with HOTH mindful of the role that zinc plays in assisting the growth of the infection, they are utilizing the BioLexa Platform to deliver a synergistic combination of a zinc chelator (binding agent), combined with an antibiotic that is demonstrating the ability to prevent these biofilms from forming. In doing so, the bacterial colonies become susceptible to elimination by both the antibiotic and the patient’s natural immune system. Thus, what HOTH is intent on proving out through its ongoing preclinical trials, is that by innovatively utilizing zinc, they can deliver an antibiotic payload to the infection site to violate the biofilms defense mechanisms.
Video Link: http://www.youtube.com/embed/Te0fFsJcCUg
University Studies Confirm Preclinical Effectiveness
To date, two university studies have proved the effectiveness of the BioLexa Platform. And, with data from both the University of Cincinnati and from the University of Miami’s, Miller School of Medicine each showing positive preclinical results, the path toward mainstream use might not be far away.
Each study first focused on the root cause of the dermatological indications, zinc, and biofilms, to demonstrate the effectiveness of the BioLexa Platform to treat specialized bacterial colonies that adhere to a infections surface as well as to one another. The University of Cincinnati study focused primarily on ways to interrupt the growth process of the infection. And, by understanding that the staph bacteria are highly resistant to antibiotic and natural immune response, they were able to isolate the importance of zinc as a means of getting into these hard to treat, recurring infections.
The data generated from the University of Cincinnati’s Herr Lab showed that zinc is not only an essential element for the formation of staph biofilms, but that zinc also triggers the adhesive properties that allow these bacteria to stick to one another. In response, they designed a platform that resulted from years of research which culminated in its development of the BioLexa Platform, a technology designed to trap all of the zinc ions by adding a binding agent (chelator) called DTPA. The study showed that the DTPA chelator can effectively mute the staph biofilm from adhering to one another which simultaneously inhibited bacterial growth and colonization.
The BioLexa Platform was then put to the test at a preclinical study conducted at the University of Miami’s, Miller School of Medicine. The study design was set up to test the ability of the BioLexa DTPA chelator to bind with an antibiotic payload in an animal study. In a controlled preclinical test to evaluate the findings at the University of Cincinnati, the researchers introduced high levels of staph bacteria to wounds on the skin of pigs to determine the effectiveness of treatment. Pigs were used due to the relative skin characteristics to humans.
Published data from the study shows that forty-four deep, and partial-thickness wounds were created on the paravertebral area on two pigs. In addition to those incisions, four additional wounds each were randomly assigned to eleven treatment groups and inoculated with S. aureus ATCC 6538 (Staphylococcus). To maintain objectivity in the trial, all wounds were treated with approximately 200 mg of appropriate preliminary treatment.
Data Showed Potential Best-in-Class Results
On day 2 of the study, wounds were assessed after using a flush and scrub technique to recover planktonic and biofilm-associated bacterial count. The results were impressive and indicated that all treatment groups, despite the variance in concentrations of DTPA alone, showed a reduction in bacterial counts (planktonic and biofilm) as compared to untreated control wounds. Perhaps more importantly from a study perspective is that the highest concentration of DTPA (30000 µM) showed the most significant reduction of both planktonic and biofilm bacterial counts as compared to other DTPA concentrations. Notably, DTPA at 5000, 10000 and 30000 µM concentrations, when combined with Gentamicin, showed a 99.99% reduction of Staphylococcus aureus planktonic bacterial count as compared to untreated wounds.
The results were determined to be statistically impactful, and demonstrated that the BioLexa Platform is able to not only perform well as a tool to significantly decrease bacterial infection by delivering a treatment agent to the infection site, in some cases its effect on the treated area provided resulting bacterial counts to be so low that they were undetectable.
Moreover, the data helped to demonstrate the universal aptitude in the BioLexa Platform to treat a much broader market for the treatment of infection in chronic wound and skin disorders. Those findings led to the recent announcements that HOTH intends to extend the utility of the BioLexa Platform.
Two New University Studies Announced
In March of 2019, Hoth Therapeutics announced two new collaborations. The first is a pilot study with the Massachusetts General Hospital Vaccine and Immunology Center (MGH) to evaluate the strength of the BioLexa Platform to treat diabetic skin disorders, a market that eclipsed $4 billion in 2018. The study design is intended to focus on chronic diabetic ulcers, both with and without substantial bacterial burdens. Expectations are for that study to start quickly, and HOTH noted in its release that they have already provided MGH with the BioLexa compound which is expected to hasten trial commencement.
The second agreement announced is a commercial licensing agreement with the University of Maryland at Baltimore, and Isoprene Pharmaceuticals, Inc. That agreement grants HOTH complete evaluation and option rights in the Dermatology Evaluation Field to develop and commercialize therapeutic compounds for the treatment of dermatological conditions in humans, another multi-billion dollar market opportunity. The highlight in that agreement grants HOTH an exclusive license for VNLG-152, a compound which has demonstrated encouraging preclinical results for the treatment of psoriasis and acne. Moreover, VNLG -152 has shown robust preclinical data in treating dermatological cancers and other skin indications.
The partnerships with both universities act as an additional step to validate the years of research and cutting-edge technology inherent to the BioLexa Platform. And, if the results from these new studies can confirm prior preclinical findings, additional market opportunities may emerge to commercialize their BioLexa Platform through licensing agreements, partnership agreements, and collaborative trials.
HOTH Is Taking The BioLexa Platform To The Next Level
As an emerging biopharmaceutical company, HOTH is well-positioned for growth. Coming off a successful IPO and at least two university studies already publishing compelling data, the company is demonstrating its ability to combine technology with innovation to deliver a new means of treating targeted indications.
The market for innovative ways to treat dermatological conditions is generating interest from big pharma as well. Recently, Pfizer acquired Anacor for $4.9 billion, a 60% premium over their then-current stock price. Pfizer’s primary interest was in Eucrisa, a topical treatment for mild to moderate eczema that is expected to generate market sales of $1.3 billion by 2022. Sanofi and Regeneron are also active in the market and recently received FDA approval for their drug Dupixent, a nonsteroidal, injectable treatment for moderate to severe atopic dermatitis. The expected sales for that drug are estimated to hit $8 billion by 2024. These acquisitions and interest may bode well for Hoth Therapeutics, who is also coming to market with innovative and cutting-edge methods to treat a variety of dermatological conditions.
HOTH currently has roughly 9.6 million shares outstanding, is well capitalized to advance its clinical trials, and owns the exclusive rights to a compelling platform that may ultimately prove its value to a broad range of treatment opportunities. As it stands, the market opportunities for HOTH present a more than $9 billion opportunity. But, with the treatment markets expected to compound its growth by more than 7% in the next five years, the possibilities should become even more pronounced.
And, with trial updates expected from its two current university studies planned in the near-term, HOTH may be a company that may prove its value to the market sooner rather than later.
Media Contact
Company Name: Perceptive Advisors
Contact Person: Kenny Soulstring
Email: Send Email
Phone: 305-766-3421
City: Miami Beach
State: Florida
Country: United States
Website: https://www.soulstringreport.com/