Biotech Brief: Reports Forecast Continued Rise in Revenues for Diabetic Ulcer Treatment Market

PALM BEACH, Florida, July 22, 2019 /PRNewswire/ -- According to a report from Grand View Research, the global diabetic foot ulcer treatment market size is expected to reach a value of USD 6.82 billion by 2025, according to a new report by Grand View Research, Inc., progressing at a CAGR of 8.2% during the forecast period. "Rising prevalence of diabetes, increasing healthcare expenses, and rapidly growing geriatric population worldwide are some of the major factors driving the diabetic ulcer treatment market. The occurrence and complications of diabetes are increasing worldwide. Global prevalence of diabetes is high and still on the rise. In 2017 $850 billion dollars was the estimated worldwide expenditure of diabetes, it has continued to grow since then. An article on Diabetic Foot: Facts and Figures added: "In the United States, a total of $176 billion is spent annually on direct costs for diabetes; As much as one third of that will be spent on lower extremity complications, such as diabetic foot ulcers. Diabetic foot ulcerations are one of the most common complications associated w/ diabetes with a global annual incidence of 6.3%. The lifetime incidence of foot ulcers in diabetic patients is 34%. More than 50% of diabetic ulcers become infected and 20% of those w/ moderate-severe infection result in amputation. Diabetes contributes to approximately 80% of the 120,000 non-traumatic amputations performed yearly in the United States. More than half of those with heel osteomyelitis (a bone infection) will undergo high level amputation." Active biotech companies with recent developments include: Hoth Therapeutics, Inc. (NASDAQ: HOTH), Midatech Pharma PLC (NASDAQ: MTP), Teva Pharmaceutical Industries Ltd. (NYSE: TEVA), Acasti Pharma Inc. (NASDAQ: ACST) (TSX-V: ACST), Outlook Therapeutics, Inc. (NASDAQ: OTLK).

The Grand View report continued: "Diabetic foot ulcers are one of the most common foot injuries that is caused due to diabetes mellitus. Management of diabetic foot ulcers aims at fast healing and wound closure, by adopting a multidisciplinary therapeutic approach so as to avoid amputation. Among different types of treatment options available, biologics held the largest share in the diabetic foot ulcer treatment market in 2017. This can be attributed to strong revenue generated by growth factors that are prescribed worldwide for their ability to promote generation of new cells and achieve wound closure. Therapy devices and wound care dressings also offer significant commercial opportunity due to their cost-effectiveness, ease of availability, and wide use in combination with other treatments at every level of wound care management."

Hoth Therapeutics, Inc. (NASDAQ: HOTH) BREAKING NEWS: Hoth Therapeutics Announces Positive Results From Pilot Study of BioLexa on Diabetic Skin Ulcers - Hoth Therapeutics, a development stage biopharmaceutical company focused on unique targeted therapeutics for patients suffering from indications such as atopic dermatitis–also known as eczema–as well as dermatological and chronic wound disorders, today announced initial results of its Pilot Study of BioLexa application on diabetic skin ulcers. 

This pilot study was designed to establish foundational protocols for assessing effectiveness of a therapeutic compound developed by Hoth Therapeutics, the BioLexa Platform, for accelerating and improving wound healing in the context of acute and chronic diabetic ulcers, using an animal model of impaired wound healing developed at Massachusetts General Hospital (MGH).

Specific study objectives were:

1. Optimize the method of application of the therapeutic compound (BioLexa) on diabetic skin wounds in the mouse models of acute and chronic diabetic wound healing established at the Vaccine and Immunotherapy Center (VIC) at MGH directed by Dr. Mark Poznansky.
2. Optimize the Staphylococcus aureus inoculation dose to achieve biofilm growth in the infected diabetic wound model.

An animal protocol amendment was submitted to and approved by the MGH Institutional Animal Care and Use Committee (IACUC) to allow the application of the BioLexa compound on wounds in the established mouse model

A full Biosafety protocol was submitted to and approved by the Partners Institutional Biosafety Committee (IBC) to allow the use of pathogens such as S. aureus. All work was performed in compliance with these institutionally approved protocols. After 22 days post-injury, the animals were euthanized and the dressings on the wounds were removed to reveal the wounds and collect tissue biopsies. Read the full Press Release and more for HOTH at:  http://www.financialnewsmedia.com/news-hoth 

Other industry developments from around the markets include:

Midatech Pharma PLC (NASDAQ: MTP) recently announced an update on its key MTX110 programme. MTX110 is designed for the treatment of childhood brain cancers such as Diffuse Intrinsic Pontine Glioma ("DIPG"), an ultra-rare highly aggressive and inoperable tumour located in the brain stem, that is universally fatal with an average life expectancy of 7 to 9 months. Midatech is also evaluating MXT110 for the treatment of Glioblastoma Multiforme ("GBM"), which is a fast-growing form of brain cancer in adults.

Dr Sabine Mueller, Principal Investigator for the study said: "Midatech's MTX110 has shown promise as one of the most potent compounds against DIPG brain tumour cells in laboratory experiments.  In this first in human study of MTX110 we are encouraged by the excellent safety profile so far and look forward to completing the safety evaluation and commencing the efficacy assessment of the drug later this year."

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) recently announced that the U.S. Food and Drug Administration (FDA) has approved AirDuo^®Digihaler™ (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, a combination therapy digital inhaler with built-in sensors that connects to a companion mobile application to provide information on inhaler use to people with asthma. AirDuo^® Digihaler™ is indicated for the treatment of asthma in patients aged 12 years and older. AirDuo^® Digihaler^™ is not used to relieve sudden breathing problems and won't replace a rescue inhaler.

"We are thrilled to be able to expand our Digihaler™ portfolio to now include a maintenance treatment," said Tushar Shah, M.D., Global Head of Specialty Clinical Development at Teva Pharmaceuticals. "With this approval, patients can now track how frequently they are using their inhalers. Granting patients the ability to track their maintenance inhaler use may help inform conversations with their doctors about treatment adherence and proper technique."

Acasti Pharma Inc. (NASDAQ: ACST) (TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre^® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia, recently announced that it has received a Notice of Allowance for its second patent to be awarded in the People's Republic of China. This new patent expands the Company's existing claims, and is valid until 2030. The new patent relates to concentrated therapeutic omega-3 phospholipid compositions, and covers certain methods for the treatment and prevention of cardiovascular diseases, metabolic syndrome, inflammation, neurodevelopmental and neurodegenerative diseases.

Outlook Therapeutics, Inc. (NASDAQ: OTLK)  a late clinical-stage biopharmaceutical company focused on developing ONS-5010, a proprietary ophthalmic bevacizumab product candidate for the treatment of wet age related macular degeneration (wet AMD) and other retina diseases, recently  announced that it has dosed the first patient in the ONS-5010-002 Phase 3 clinical trial.

"We are pleased to begin dosing patients in the ONS-5010-002 study, our second Phase 3 clinical trial for ONS-5010. This represents the achievement of another important milestone in our streamlined clinical and regulatory strategy, which is designed to support a Biologics License Application, or BLA, submission for ONS-5010 in wet AMD by the end of 2020," said Lawrence A. Kenyon, President, Chief Executive Officer and Chief Financial Officer.

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