FinancialNewsMedia.com News Commentary - Atopic dermatitis is a chronic inflammatory skin condition characterized by red, itchy, swollen, and broken skin. White fluid can leak from the affected region, necessitating treatment. The atopic dermis is more common in children and can become more serious as they get older. Atopic dermatitis is caused by a genetic mutation, environmental contamination, immune system dysfunction, and skin permeability issues. Dry skin, irritants, fatigue, allergies, infection, and heat/sweating are the primary causes of atopic dermatitis. A report from Mordor Intelligence said that the atopic dermatitis market is expected to grow at a CAGR of 7.8% during the forecast period of study during 2021-2026. The report said: "Allergy plays a significant role in patients with atopic dermatitis. The disease mostly flares up when the patient is around things that cause allergic reactions. It is particularly common in infants, as well as children, and is estimated to account for about 10-20% for those having eczema, as mentioned under the American College of Allergy, Asthma and Immunology. Food allergy has been essentially highly debatable for decades in atopic dermatitis, with some common food, including milk, egg, and soy. There is a lot of literature that provides pieces of evidence that common food exacerbate atopic dermatitis. The malfunction in the immune system of the human body due to asthma is also among the major causes of atopic dermatitis." Active companies in the markets today include: Hoth Therapeutics, Inc. (NASDAQ: HOTH), Longeveron Inc. (NASDAQ: LGVN), Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), Sanofi (NASDAQ: SNY), Novartis AG (NYSE: NVS).
Mordor Intelligence added: "Additionally, skin irritants occur due to certain soaps, detergents, perfumes, etc. Thus, allergic reactions, particularly due to food, are one of the major factors that are increasing the burden of atopic dermatitis and driving market growth. Other factors driving the market are the rich pipeline portfolio, with products in advanced stages of clinical development, increasing government funds to support research for this disease, and rising campaigns to raise eczema awareness. North America captured the largest market share and is expected to retain its dominance... North America is expected to provide high business for the atopic dermatitis market, over the forecast period. The factors, such as high treatment awareness among the patient population across the United States and Canada, healthcare infrastructure, early adoption of novel medications, better reimbursement policies, and increasing business partnerships of pharmaceutical companies with contract research organizations in the emerging markets, help the lucrative nature of this market in North America."
Hoth Therapeutics, Inc. (NASDAQ: HOTH) BREAKING NEWS: Hoth Therapeutics' Enrollment and Dosing in Second Cohort in Phase 1b Human Trial for Atopic Dermatitis Under Way - Hoth Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing new generation therapies for unmet medical needs, is pleased to announce that enrollment and dosing has begun for the second cohort in its First in Human clinical trial investigating topical BioLexa for the treatment of mild to moderate atopic dermatitis, also known as eczema.
"We are excited to have reached this pivotal milestone in our BioLexa development program to begin dosing adult patients," stated Stefanie Johns, Chief Scientific Officer of Hoth Therapeutics. "The second cohort is exclusively made up of current atopic dermatitis patients and we look forward to sharing top of the line data in 2022."
Hoth is conducting the BioLexa clinical trial in Australia Patient enrollment continues for Phase 1. Anyone in Australia that is interested may review trial requirements at ClinicalTrials.Gov. CONTINUED... Read the Hoth Therapeutics full press release by going to: https://ir.hoththerapeutics.com/news-releases
In other news and developments of note in the markets this week:
Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, recently announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation for Lomecel-B for the treatment of Hypoplastic Left Heart Syndrome (HLHS), a rare and life-threatening congenital heart defect in infants. Lomecel-B, an investigational allogeneic, bone marrow-derived medicinal signaling cell (MSC) product, is currently being evaluated in a Phase 2 trial.
"We are pleased by FDA's acknowledgment of the urgent need for a safe and effective treatment for children born with this rare and devastating congenital heart defect," stated Longeveron co-founder and Chief Science Officer Joshua M. Hare, M.D. "We are encouraged by our Phase 1 clinical data, and the progress being made in the ongoing Phase 2 trial. Lomecel-B represents a unique cell therapy approach that could potentially be administered at the same time as surgery in these critically impacted infants."
Approximately 1,000 babies are born with HLHS each year in the U.S. HLHS babies have an underdeveloped left ventricle, which impairs the heart's ability to pump blood throughout the body. HLHS is often fatal without surgical intervention, in which three surgical procedures are performed over the period of about 5 years, to allow the right ventricle to be configured to pump blood to the body.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) recently announced that the European Commission (EC) has approved the casirivimab and imdevimab antibody cocktail, known as REGEN-COV(R) in the U.S. and Ronapreve(TM) in the European Union (EU) and other countries. The EC granted marketing authorization for the antibody cocktail for people aged 12 years and older for the treatment of non-hospitalized patients (outpatients) with confirmed COVID-19 who do not require oxygen supplementation and who are at increased risk of progressing to severe COVID-19, and to prevent COVID-19. This decision follows a positive opinion by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP).
"This approval adds to the growing number of countries that have recognized our antibody cocktail as an important therapy against COVID-19 to treat non-hospitalized patients already infected with the virus and to prevent infection in the first place," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. "With today's approval, we hope countries in the European Union will accelerate their adoption of this formidable tool to reduce the burden of COVID-19. For non-hospitalized infected individuals, our antibody cocktail was shown to reduce the risk of hospitalization or death by 70%; and in the prevention setting it reduced the risk of symptomatic infections by 82%. Further, recently released data not yet reviewed by the EMA suggest a single dose provided long-term protection against COVID-19, beyond the currently authorized once-monthly dosing; we will share these new data with regulatory authorities, including the EMA, to better meet the needs of these patients."
Sanofi (NASDAQ: SNY) recently announced an equity investment of $180 million and a new strategic collaboration with Owkin comprised of discovery and development programmes in four exclusive types of cancer, with a total payment of $90 million for three years plus additional research milestone-based payments. Owkin, an artificial intelligence (AI) and precision medicine company, builds best-in-class predictive biomedical AI models and robust data sets. With the ambition to optimize clinical trial design and detect predictive biomarkers for diseases and treatment outcomes, this collaboration will support Sanofi's growing oncology portfolio in core areas such as lung cancer, breast cancer and multiple myeloma.
To accelerate medical research with AI in a privacy-preserving way, Owkin has assembled a global research network powered by federated learning, which allows data scientists to securely connect to decentralized, multi-party data sets and train AI models without having to pool data. This approach will complement Sanofi's emerging strength in oncology, as the company's scientists apply cutting-edge technology platforms to design potentially life-transforming medicines for cancer patients worldwide.
Novartis AG (NYSE: NVS) will highlight new data on Scemblix(R) (asciminib), recently approved by the US Food and Drug Administration, as well as its next-generation CAR-T platform and the latest research results for an array of hematology medicines at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition (December 11-14; Atlanta and virtually). More than 100 abstracts, including 24 oral presentations, will be shared at the meeting.
New data will be presented for Kymriah(R)(tisagenlecleucel), as well as CAR-T pipeline compounds YTB323 and PHE885, along with sabatolimab (MBG453), Scemblix(R) (asciminib), iptacopan (LNP023), Adakveo(R) (crizanlizumab), Jakavi(R)* (ruxolitinib) and Promacta(R)/Revolade(R)(eltrombopag).
"Novartis is relentless in its pursuit of breakthrough innovation for patients with blood cancers and life-threatening blood disorders," said Susanne Schaffert, PhD, President, Novartis Oncology. "The breadth of new data presented at ASH demonstrates the promise of our advanced therapeutic platforms with exciting new approaches in immuno-oncology and CAR-T therapies that aim to transform the lives of patients."
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