Miami Beach, May 21, 2019 (Issuewire.com) - Hoth Therapeutics, Inc. is working on expanding its strategic opportunities through an announcement that the company has signed a term sheet with Zylö Therapeutics Inc, to co-develop a new treatment for patients suffering from Cutaneous Lupus Erythematosus (CLE), a chronic autoimmune disease that affects the skin. Hoth Therapeutics is a biopharmaceutical company focused on novel targeted therapeutics for patients suffering from indications such as atopic dermatitis-also known as eczema-as well as dermatological and chronic wound disorders.
Although the final terms have not been disclosed, a consummated agreement will allow for both HOTH and Zylö to co-develop Zylö's targeted treatments to combat the debilitating effects of CLE. Zylö, who is dedicated to bringing innovative technologies to multiple facets of medicine, brings to the deal an innovative sustained-release drug-delivery system that was developed by Joel Friedman MD Ph.D., Adam Friedman MD FAAD, and Andrew Draganski PhD. The delivery system, which utilizes patented xerogel-derived nanoparticles, called Z-pods, is showing the capability to deliver--in a sustained and controlled manner--notoriously hard-to-deliver therapeutic agents through topical administration.
University Study Confirms Topical Administration Effectiveness Against CLE
According to study data published by the scientists at Einstein College of Medicine, compelling results demonstrated that topical administration with AEA-loaded nanoparticles significantly prevents the development of CLE in an established animal model of lupus. Moreover, the data reinforces and highlights the utility of targeting the endocannabinoid system for autoimmune rheumatic diseases. More specifically, the study supports the thesis that AEA loaded into Z-pods improves drug skin penetration, reduces the expected inflammatory cytokine secretion by keratinocytes when exposed to ultraviolet radiation, prevents the development of CLE skin lesions, improves skin histopathology, prevents inflammation and structural damage on histology and reduces macrophages and C3 accumulation.
The market opportunity can be substantial, and according to estimates by the Lupus Foundation of America (LFA), roughly 1.5 Million Americans currently suffer from lupus, with an estimated 16,000 new cases reported annually, striking mostly women of child-bearing age. The global opportunity for treatment options is even more significant, and the LFA estimates that at least five million people may have some form of the disease, with the at least two-thirds expected to develop CLE. From a market perspective, HOTH and Zylö will be looking to develop better treatment options for patients with lupus who currently spend upwards of $6,000 to $10,000 per year for treatment, and for some in that group, spending more than three times that amount per year is not uncommon.
https://www.youtube.com/watch?v=Te0fFsJcCUg
The Deal With Zylö Will Expand Strategic Opportunities For HOTH
For Hoth Therapeutics, Inc., the deal would expand its vision to develop and advance new science and innovative technology to take advantage of next-generation medical needs.
By leveraging the compelling data generated from its globally licensed BioLexa Platform, HOTH is strategically focused on bringing to the market proprietary therapeutic options for patients suffering from indications such as atopic dermatitis (eczema). That market alone is substantial, and opinion research indicates that many of the 32 million patients in the U.S. market that suffer from eczema and atopic dermatitis are in need for better treatment options, with a large subset of sufferers complaining that currently available topical solutions cause, among other things, stinging, irritation, skin infection, and fragile skin. HOTH, who's preclinical trial data is already showing compelling results, is raising optimism that by utilizing the BioLexa Platform, the company can ultimately bring to market innovative and useful treatment options for patients needing better therapeutic results.
HOTH may be well-positioned to deliver those options, coming off of its recent $7 million IPO that will allow HOTH to act independently to further the Platform applications. Additionally, by holding the global and exclusive license to the BioLexa Platform, HOTH is in a unique position, especially as a relatively new contributor to the dermatologic skin disorders market, to field potential partner calls rather than looking for additional funding in the near term that could be dilutive to the shareholder base.
BioLexa Platform Is Showing Compelling Results In Treating Skin Disorders
To date, the BioLexa Platform has been delivering compelling results from preclinical studies. The patent protected Platform, developed at the University of Cincinnati, is based on cutting-edge scientific research that earned its first set of patent protection in 2008. The science is further protected by additional patents granted in 2013 and 2017, which broaden the scope of the BioLexa technology to include biochemical and protein science indications.
Differentiating itself from currently marketed technology, the advantage of the BioLexa Platform is that it is targeting a primary cause of severe infection, "biofilms." According to the Centers for Disease Control, these biofilms are implicated in more than two-thirds of all skin infections and serve as the primary barrier to stifle effective treatment. Thus, these biofilms facilitate bacterial growth by becoming functional bacterial colonies that are highly resistant to both antibiotics and natural immune responses. But, HOTH may have found the link to curb the bacterial growth.
Through its preclinical research, HOTH has found that staph infection requires zinc to not only form the biofilms, but it also needs it for the bacteria to grow and resist treatment. HOTH's position is focused on utilizing the role of zinc to limit the growth of the infections by utilizing the BioLexa Platform to deliver a synergistic combination of a zinc chelator (binding agent) and an antibiotic that prevents biofilms from forming, leaving the bacterial susceptible to elimination by both the antibiotic and the patients natural immune system. In other words, if zinc is a prime ingredient necessary for bacterial colony growth, HOTH believes that they can utilize its function to act as a binding agent to serve as the tool to deliver an antibiotic payload. Two university studies are proving that point.
University Studies Prove The Effectiveness Of The BioLexa Platform
Two studies have already delivered supporting results that prove the effectiveness of the BioLexa Platform. The first set of positive data resulted from years of scientific research at the University of Cincinnati, and the other collection of data came from a preclinical trial conducted at the University of Miami's, Miller School of Medicine.
The premise for each was to stay focused on the root cause of the dermatological indications, biofilms. Then, by advancing the premise that biofilms act as the specialized colonies of bacteria that adhere to a surface as well as to one another, the scientists at the University of Cincinnati found a way to interrupt the growth process of the infection. They also determined that because staph bacteria are highly reistant to antibiotic and natural immune response, they could isolate the importance of zinc as a means of getting into these hard to treat, recurring infections.
The study at University of Cincinnati's Herr Lab proved 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. Thus, the resulting BioLexa Platform was designed to trap all of the zinc ions by adding a binding agent (chelator) called DTPA, which prevents the staph biofilm from adhering to one another which then inhibited bacterial growth and colonization.
The next phase of the confirmatory study to show the effectiveness of the BioLexa Platform came from a preclinical trial conducted at the University of Miami's, Miller School of Medicine. That study design was intended to test the ability of the BioLexa DTPA chelator to bind with an antibiotic payload in an animal study. The university study conducted a controlled preclinical test whereby the researchers introduced high levels of staph bacteria to wounds on the skin of pigs, used for the similarity of skin properties to humans, to determine the effectiveness of treatment. The results were compelling.
In the study, forty-four deep, partial-thickness wounds were created on the paravertebral area on two pigs. Additionally, four wounds each were randomly assigned to eleven treatment groups and inoculated with S. aureus ATCC 6538 (Staphylococcus). Per study protocol, each wound was treated with approximately 200 mg of similar initial treatment to maintain study disciplines.
On day 2 of the preliminary evaluation, the wounds were assessed using a flush and scrub technique to recover planktonic and biofilm-associated bacterial count. As stated, the results were compelling and showed that all treatment groups, despite the variance in concentrations of DTPA alone demonstrated a reduction in bacterial counts (planktonic and biofilm) as compared to untreated control wounds. The highest concentration of DTPA (30000 µM) alone showed the most significant reduction of both planktonic and biofilm bacterial counts as compared to other DTPA concentrations. In a comparative analysis, 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. Some wounds showed no detectable levels of infection.
Additional University Studies Intended To Prove BioLexa Platform Effectiveness
Earlier this year, Hoth Therapeutics announced two new collaborations. The first, published in March, is a pilot study with the Massachusetts General Hospital Vaccine and Immunology Center to study the BioLexa Platform on diabetic skin disorders, a market that surpassed $4 billion in 2018. The study will focus on chronic diabetic ulcers, both with and without substantial bacterial burdens. That study is expected to commence quickly, and HOTH has noted in a previous press release that they have provided MGH with the BioLexa compound.
The second is a commercial licensing agreement with the University of Maryland at Baltimore, and Isoprene Pharmaceuticals, Inc. As part of that agreement, HOTH has been granted 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. An important part of that deal is that HOTH has been granted an exclusive license for VNLG-152, a compound that has demonstrated encouraging preclinical results for the treatment of psoriasis and acne. Additionally, VNLG -152 has shown robust preclinical data in treating dermatological cancers and other dermatologic indications as well.
These two new collaborations are looking to expand the opportunities for the BioLexa Platform and allow HOTH to extend its science into additional multi-billion dollar market opportunities. Moreover, these two agreements may open the door to further possibilities to commercialize their BioLexa Platform through licensing agreements, partnership agreements, and collaborative trials.
A Growing HOTH Offers Value Opportunity
For the past two weeks, HOTH has been gaining the attention of investors, and the stock traded higher by more than 17% since the beginning of May. But, even the best of companies do not move in a straight line higher when it comes to growth, so, patience is recommended while watching HOTH develop. However, unlike many emerging biopharmaceutical companies, it's fair to say that HOTH is off to a good start and can point to its successful IPO, its impactful results from its animal study at the U of M, and its two recently added licensing agreements with major Universities.
Now, with its expected deal with Zylö Therapeutics Inc. to co-develop a new treatment for patients suffering from Cutaneous Lupus Erythematosus (CLE) to take place in the near-term, the proof that HOTH is an ambitious and opportunistic company is emerging. And, it could be a strategy that strengthens its market position in the coming quarters.
After its recent IPO, HOTH is trading on the NasdaqCM and has an outstanding share count of just 9.6 million shares as of 4/29/19. The company is currently well-capitalized to extend the reach of its cutting-edge BioLexa Platform that may soon provide additional data to support its emergence as a useful tool to treating atopic dermatitis, diabetic skin disorders, and chronic wound and skin indications. And, with a combined market opportunity that exceeds $9 billion from just their initial target markets that address dermatological indications, HOTH may be poised for considerable growth in the coming quarters, and represent a compelling value opportunity today.
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