Palm Beach, FL – November 6, 2019 – Atopic dermatitis is a widespread chronic inflammatory skin condition that can affect patients of all ages and is the result of a complex interplay of environmental, immunological, genetic, and pharmacologic factors. The atopic dermatitis market has historically remained stagnant and the pipeline for drugs in late-stage development was lacking, but recent developments have reignited interest in the treatment of the disease, especially as the estimated drug-treated population may grow to 24,000,000 people over the next decade, according to reports from Grand View Research. In 2016 the market size was valued at USD 4.1 billion and was expected to expand at a CAGR of 6.6% through 2022. In 2018 the projection rose and Grand View projected the market to reach USD 6.41 billion by 2022, according to a new report by Grand View Research, Inc., exhibiting a CAGR of 6.6% during the forecast period. Various factors such as emergence of novel therapeutics and growing uptake of targeted therapies are stimulating the growth of the market.Active biotech companies with recent developments include: Hoth Therapeutics, Inc. (NASDAQ: HOTH), NextCure, Inc. (NASDAQ: NXTC), Paratek Pharmaceuticals, Inc. (NASDAQ: PRTK), Agile Therapeutics, Inc. (NASDAQ: AGRX), Viking Therapeutics, Inc. (NASDAQ: VKTX).
Recently, GlobalData increased the projections and estimated that Global sales in the atopic dermatitis market are expected to grow to $18.3B by 2027, at a Compound Annual Growth Rate (CAGR) of 11.1% from 2017-2027. GlobalData forecasts the US to grow to $13.6B (74.5% of global sales), the 5EU to grow to $4B (21.7% of global sales), and Japan to grow to $693M (3.8% of global sales) over the next 10 years. Grand View added: “Exact cause of the condition is unknown; however, the disease is speculated to result from a combination of environmental and genetic factors. AD affects males and females equally. Approximately 60.0% patients with AD develop symptoms in the first year and roughly 90.0% patients show symptoms by the age of five (atopic march). Disease onset after the age of 30 is rare and may be caused by exposure to harsh environmental conditions.”
Hoth Therapeutics, Inc. (NASDAQ: HOTH) BREAKING NEWS: Hoth Therapeutics, a 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 initiating a Phase 1 confirmatory study, related to their proprietary AEA-loaded Z-pods™ in the treatment of Cutaneous Lupus Erythematosus [CLE], a chronic autoimmune disease that affects the skin.
The study is being conducted in partnership with Zylö Therapeutics to confirm that topical administration of Hoth’s AEA-loaded Z-pods™ inhibits the development of CLE lesions in a well-established animal model of lupus. Test protocol requires weekly scoring and a treatment period of 10 weeks after the initial lesions are recorded. The trials are piloted by Jackson Laboratory, an independent, nonprofit biomedical research institution.
“Commencing this confirmation study is an important step toward underlining the transformative potential of AEA-loaded Z-pods™ in patients suffering from Cutaneous Lupus Erythematosus,” stated Mr. Robb Knie, CEO of Hoth Therapeutics, Inc. “We are pleased with the progress we have made in the development of our lupus treatment since announcing our strategy earlier this year with our partner Zylö Therapeutics. Management looks forward to reporting key findings with the completion of this study, which we expect will provide a critical point of validation for our proprietary topical solution.”
Hoth owns an exclusive license to develop Anandamide-loaded Z-pods™ for the treatment of CLE in North America. Anandamide, generally referred to as AEA, is one of the cannabinoids that the human body makes naturally. The Company also possesses rights related to geographic expansion and to follow-on indications such as psoriasis and rheumatoid arthritis. Read the full Press Release and more for HOTH at: https://financialnewsmedia.com/news-hoth
Other industry developments from around the markets include:
NextCure, Inc. (NASDAQ: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing next-generation immunomedicines for cancer and other immune-related diseases, announced that the company will host and webcast an event with its Chief Medical Officer at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) on Saturday, November 9, 2019 at 6:30 p.m. Eastern Time at the Gaylord National Hotel & Convention Center in National Harbor, Maryland. At the event, NextCure will discuss updated clinical results from the Phase 1 portion of its ongoing trial with NC318 that are being presented earlier in the day at SITC. Institutional investors and analysts are requested to rsvp to Drew Phillips at drew.phillips@westwicke.com or by phone at 443-213-0497.
Paratek Pharmaceuticals, Inc. (NASDAQ: PRTK) a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics, announced the outcome of its two exploratory Phase 2 clinical studies evaluating the efficacy and safety of its once-daily oral and intravenous (IV) modernized tetracycline omadacycline in patients with two common forms of urinary tract infections (UTI).
Both studies were adaptive studies which included multiple dosage regimens of omadacycline with the objective to identify a dose regimen for further investigation that would be clinically and microbiologically effective in each of the UTI indications to be studied.
Agile Therapeutics, Inc. (NASDAQ: AGRX) a women’s healthcare company, announced a positive outcome from today’s meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) of the U.S. Food and Drug Administration (FDA). The BRUDAC met to discuss the Company’s New Drug Application (NDA) for its lead product candidate, Twirla® (AG200-15), an investigational combined hormonal contraceptive patch.
The BRUDAC voted 14 to 1, with 1 abstention, that the benefits of Twirla (AG200-15) in the prevention of pregnancy outweigh the risks to support approval.
Viking Therapeutics, Inc. (NASDAQ: VKTX) a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, recently announced its financial results for the third quarter ended September 30, 2019, and provided an update on its clinical pipeline and other corporate developments.
“The last few months have been an exciting and productive period at Viking as we prepare for important near-term milestones,” stated Brian Lian, Ph.D., chief executive officer of Viking Therapeutics. “With respect to our thyroid receptor beta agonist VK2809, in the third quarter we completed key chronic toxicity studies to support long-term dosing in humans. This work, along with data from completed clinical and other non-clinical studies, formed the basis of an IND application that was submitted to the FDA to initiate a Phase 2b study of VK2809 in patients with biopsy-confirmed NASH. With respect to VK0214, our second thyroid receptor beta agonist, we continued the IND-enabling work that will allow us to initiate clinical development, including a proof-of-concept study in patients with X-ALD, in the first half of next year. In addition to advancing our clinical programs, we’ve also maintained a tight focus on operating expenses, and ended the quarter with approximately $290 million in cash and equivalents. We believe our current balance sheet is sufficient to see us through multiple value inflection points.”
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