Dermatitis, Allergic Contact

The annual meeting of the American Academy of Dermatology was held from March 7 to 11 in Orlando, Florida, and attracted clinicians, academicians, allied health professionals, and others interested in dermatology. The conference highlighted recent advances in the diagnosis and management of dermatological conditions. During one presentation, Joshua Cook, M.D., of the Columbia University Irving Medical Center in New York City, noted that targeting insulin resistance and hyperinsulinemia is important not only for the treatment of obesity and diabetes, but potentially also independently for improving metabolism-related inflammatory skin diseases like psoriasis and hidradenitis suppurativa. Cook discussed the tight epidemiologic connection between obesity, type 2 diabetes, and inflammatory skin diseases, especially psoriasis. The mechanistic basis of this connection is likely due to insulin resistance and/or hyperinsulinemia. Cook noted that hyperinsulinemia likely drives excessive proliferation and inflammation of skin lesions in psoriasis and other inflammatory skin diseases, even in the setting of systemic insulin resistance. "We are currently performing clinical studies to better understand the role of insulin action in psoriasis," Cook said. "Health care providers should strongly consider screening patients with overweight/obesity and inflammatory skin diseases with hemoglobin A1c, fasting glucose, and lipid profiles. Treatment of obesity and type 2 diabetes with glucagon-like peptide-1 receptor agonists may improve inflammatory skin disease activity (an area of active research). There may also be roles for metformin and pioglitazone in inflammatory skin disease treatment in select patients." Abstract During another presentation, Daniel Charles Butler, M.D., of the University of Arizona College of Medicine in Tucson, discussed the connection between itch and aging. Butler discussed how itch is very common in the older adult population. He noted there are many etiologic contributors to itch, including the immune system, the skin barrier, and the cutaneous nerves, all of which are uniquely impacted by aging. "As practicing clinicians, we need to substantiate itch as a real, impactful but targetable symptom and disease," Butler said. "The connection between age and itching allows us to target contributing etiologies with available treatments. For example, itch in older adults is often multifactorial with immunologic changes and neuropathic changes. This allows us to use treatment to target multiple contributors." Butler disclosed financial ties to the pharmaceutical industry. Abstract Adam J. Friedman, M.D., of the George Washington School of Medicine and Health Sciences in Washington, D.C., discussed how food allergy is an extremely rare cause of chronic urticaria with no identifiable cause (CSU), and some food intolerances may contribute, but responses are highly individualized and elimination diets should only be done in a structured way. Friedman provided insight into how urticaria, both acute and chronic, is a common condition, affecting as many as 80 percent of people at some point in their lives. For approximately 1 percent of individuals who develop chronic urticaria, this condition can last for years, significantly impacting quality of life. While patients often search for a clear trigger, more than two-thirds of cases occur without an identifiable cause. Although food allergies can trigger acute urticaria, particularly in children, when it comes to CSU, food allergy is rarely a culprit. Friedman noted that, instead, he often sees food intolerances or pseudoallergic reactions, which may contribute to symptoms in some individuals. This distinction is important because a true food allergy involves an immune response, and food intolerances tend to be more variable, harder to predict, and less understood. A number of studies have explored dietary interventions in CSU, but the results so far have been mixed at best. "At the end of the day, lifestyle modifications are cost-effective, noninvasive, and worth exploring, but they require proper education and guidance -- both for patients and physicians. This remains an underfunded and underresearched area, but as interest grows, we may gain clearer insights into how diet influences CSU," Friedman said. "While it's tempting to believe that cutting out a few foods might be a silver bullet, CSU is a complex, multifactorial condition. And as with most things in dermatology, there's rarely a one-size-fits-all approach." Friedman disclosed financial ties to the pharmaceutical industry. Abstract Peggy A. Wu, M.D., of the University of California Davis in Sacramento, discussed how systemic contact dermatitis (SCD) is a diagnosis to consider in the setting of a chronic, recalcitrant rash in the right clinical setting, although the diagnosis is not common. Wu discussed how SCD represents a small subset of allergic contact dermatitis (ACD) diagnoses. Like ACD, SCD is thought to be a delayed hypersensitivity reaction, and as such, reactions follow exposures in hours to days. SCD can present in a myriad of ways, including, most commonly, vesicular bilateral hand dermatitis, generalized dermatitis, and periorificial dermatitis. Frequent causes of SCD include exposure to nickel, balsam of Peru, and fragrance. The diagnosis is usually made in the setting of a chronic rash with positive patch test results to an allergen with plausible, relevant dietary sources and following topical avoidance of identified allergens. "Physicians should consider the diagnosis of SCD in the setting of a recalcitrant chronic rash with certain phenotypes (vesicular bilateral hand dermatitis, generalized dermatitis, periorificial) and positive patch test reactions to allergen(s) with a possible relevant dietary source," Wu said. "A recommended approach to SCD is to start with a one-month trial of dietary modification. Longer courses of dietary modification may benefit from working with a dietitian to maintain nutritional need." Abstract AAD: Baricitinib Efficacious for Hair Regrowth in Teens With Severe Alopecia Areata TUESDAY, March 18, 2025 -- For adolescents with severe alopecia areata, baricitinib is efficacious for hair regrowth, according to a study presented at the annual meeting of the American Academy of Dermatology, held from March 7 to 11 in Orlando, Florida. Read Full Text AAD: Maintenance of Low Eczema Activity Seen After About 80 Days Off Tapinarof FRIDAY, March 14, 2025 -- Patients with atopic dermatitis who achieve completely clear skin with tapinarof ( Vtama ) cream maintain low disease activity after about 80 days off treatment, according to a study presented at the annual meeting of the American Academy of Dermatology, held from March 7 to 11 in Orlando, Florida. Read Full Text AAD: Ivarmacitinib 4 mg, 8 mg Efficacious for Adults With Severe Alopecia Areata THURSDAY, March 13, 2025 -- For adults with severe alopecia areata, ivarmacitinib, a selective Janus kinase 1 inhibitor, at doses of 4 and 8 mg is efficacious and tolerable, according to a study presented at the annual meeting of the American Academy of Dermatology, held from March 7 to 11 in Orlando, Florida. Read Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

New research will explore key aspects of eczema from the science behind itch and inflammation, to skin barrier dysfunction as a biomarker, to the microbiome NOVATO, Calif., Feb. 27, 2025 /PRNewswire/ -- The National Eczema Association (NEA) today announced the recipients for its 2024 research grant cycle. From both U.S.-based and international applications, the research projects of nine outstanding investigators were selected, representing grants totaling $365K. NEA has now invested over $4.4 million since its first grant was awarded in 2004. Collectively, NEA-funded grants for basic science, clinical and translational research have supported a deeper understanding of the symptoms, comorbidities, and burdens of eczema, provided insights into new treatment strategies, and furthered the ability to improve care and prevention. For many grantees, NEA's early funding propels a career in research, with more than one third going on to receive funding from the National Institutes of Health (NIH), leading to significant developments in our understanding of eczema "Eczema is a chronic condition that affects over 31 million people in the U.S., many with significant impacts to their overall health and quality of life," says Wendy Smith Begolka, Chief Strategy Officer at NEA. "The NEA grant program was started to fill a much-needed gap in research and, over 20 years later, it's encouraging to see the breadth and scope of work represented, with real potential to improve lives." The 2024 research grants were awarded as follows: Champion Research Grant– Encourages proven researchers to continue research on emerging or ongoing challenges in eczema or bring their expertise to the field of eczema. Christopher Montgomery, MD, Nationwide Children's Hospital , Columbus, OH A Staphylococcus aureus vaccine to prevent atopic dermatitis Childhood Eczema Challenge Grant – Created in collaboration with the Pediatric Dermatology Research Alliance (PeDRA), this award is intended to accelerate research that improves the health and quality of life of pediatric patients and their families. Diego Lopez, DDS, MPH, PhD, University of Melbourne , Melbourne, Australia Does the composition of oral microbes contribute to eczema in early life? Catalyst Research Grant – Designed to support talented early-career scientists on the path toward becoming the next generation of eczema thought leaders by supporting hypothesis-driven research projects. James Chambers, MPharm, MSc, PhD, Tufts School of Medicine , Boston, MA Examining US commercial health plan coverage of atopic dermatitis therapies: A longitudinal analysis Zelma Chiesa Fuxench MD, MSCE, University of Pennsylvania , Philadelphia, PA Characterization of the cutaneous microbiome in adult patients with seborrheic dermatitis with emphasis on skin mycobiota. George Maiti, PhD, NYU Grossman School of Medicine , New York, NY Extracellular matrix proteoglycans regulate T cell functions during allergic contact dermatitis Meng-Jen Wu, PhD, Johns Hopkins University, Baltimore, MD Addressing unmet needs: Evaluating a novel tri-model therapeutic to address itch and infection in atopic dermatitis Engagement Research Grant – Intended for emerging investigators exploring a new research concept, piloting a new experiment, or undertaking a novel or secondary data analysis. Mohini Bhattacharya, PhD, University of Colorado, Denver, Denver, CO Skin matrisome as a determinant of S. aureus skin infection severity Raquel Sanabria-de la Torre, MS, Virgen de las Nieves University Hospital , Granada, Spain Genetic deregulation and skin barrier dysfunction as biomarkers of therapeutic response in patients with atopic dermatitis Emily Robbins, DO, NIH/NIAID , Bethesda, MD An Infants' Microbiome in the Neonatal Intensive Care Unit and Their Later Risk of Development of Atopic Dermatitis Learn more about NEA's ongoing support of eczema research. About the National Eczema Association Founded in 1988, the National Eczema Association (NEA) is a 501(c)(3) nonprofit and the largest patient advocacy organization serving the over 31 million Americans who live with eczema and those who care for them. NEA provides programs and resources to elevate the diverse lived experience of eczema, and help patients and caregivers understand their disease, actively engage in their care, find strength in one another – and improve their lives. Additionally, NEA advances critical eczema research and partners with key stakeholders to ensure the patient voice is represented and valued in education, care and treatment decision-making. The eczema community is at an exciting juncture, with increased recognition of the seriousness and burden of eczema and a surge in scientific interest and development of new treatments. Bolstered by NEA's strategic plan, Blueprint 2025, we are driving toward the ultimate vision: a world without eczema. Learn more at NationalEczema.org. SOURCE National Eczema Association WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

TORONTO, Feb. 14, 2025 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, today reported financial results for the three months ended December 31, 2024 and provided an update on its business. During the quarter, the company advanced its main asset, EB06, an anti-CXCL10 monoclonal antibody candidate being developed for the effective and durable treatment of vitiligo. Preparation for the manufacturing campaign is underway, with data anticipated to be submitted to regulators at the U.S. Food and Drug Administration (FDA) during the middle of 2025. The company intends to pursue an investigational new drug (IND) application for a Phase 2 study in moderate-to-severe nonsegmental vitiligo patients. Edesa anticipates topline results could be available within as few as 12 to 18 months following regulatory clearance by the FDA. Health Canada has previously granted approval to initiate this Phase 2 clinical study. The company also reported recently that the development of its anti-TLR4 drug candidate, EB05 (paridiprubart), is fully funded by the U.S. government in a Phase 2 study investigating novel threat-agnostic host-directed therapeutics. As a result of this trial being sponsored and run by the U.S. government, Edesa can prioritize the development of EB06 as a vitiligo therapy. “Our goal is to be in a position to rapidly launch our vitiligo clinical trial following regulatory clearance,” said Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech. “Vitiligo significantly impacts the lives of millions worldwide, yet there are no approved drugs that address the systemic nature of the disease. We believe that a targeted immunotherapy, like EB06, that interrupts the disease process on a key point in vitiligo pathogenesis (further downstream from JAK inhibitors) could offer a safe and efficacious treatment.” Edesa's Chief Financial Officer Stephen Lemieux reported that financial results for the first quarter of fiscal year 2025 were in line with management’s expectations and benefited from a subsequent equity financing. "With a stronger balance sheet, which includes $15.0 million in gross proceeds raised in our institutional investor-led offering, we believe we are well positioned to advance our vitiligo program toward topline data and fund Edesa’s current operating plan.” Financial Results for the Three Months Ended December 31, 2024 Total operating expenses were unchanged at $1.9 million for the three months ended December 31, 2024 and December 31, 2023: Research and development expenses increased by $0.3 million to $1.0 million for the three months ended December 31, 2024 compared to $0.7 million for the same period last year primarily due to increased external research expenses related to manufacturing the company’s investigational drug, paridiprubart.General and administrative expenses decreased by $0.3 million to $0.9 million for the three months ended December 31, 2024 compared to $1.2 million for the same period last year primarily due to a decrease in salaries and related costs, noncash share-based compensation and professional service fees. Total other income increased by $102,000 to $281,000 for the three months ended December 31, 2024 compared to $179,000 for the same period last year. This increase was primarily due to an increase in reimbursement funding from the Canadian government's Strategic Innovation Fund, which was partially offset by a decrease in interest income. For the quarter ended December 31, 2024, Edesa reported a net loss of $1.6 million, or $0.48 per common share, compared to a net loss of $1.7 million, or $0.54 per common share, for the quarter ended December 31, 2023. Working Capital At December 31, 2024, Edesa had cash and cash equivalents of $1.6 million and working capital of $0.2 million. Subsequent to the quarter end, the company received $15.0 million in gross proceeds from a private placement of preferred and common shares. Calendar Edesa plans to participate in the American Academy of Dermatology Annual Meeting from March 7- 11, 2025, BIO Europe Spring 2025 from March 17-19, 2025, and the H.C. Wainwright Autoimmune & Inflammatory Disease Virtual Conference on March 27, 2025. Attendees interested in meeting with company representatives can request meetings through the conference organizers or by contacting Edesa directly at investors@edesabiotech.com. About Edesa Biotech, Inc. Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company developing innovative ways to treat inflammatory and immune-related diseases. Its clinical pipeline is focused on two therapeutic areas: Medical Dermatology and Respiratory. In Medical Dermatology, Edesa is developing EB06, an anti-CXCL10 monoclonal antibody candidate, as therapy for vitiligo, a common autoimmune disorder that causes skin to lose its color in patches. Its medical dermatology assets also include EB01 (1.0% daniluromer cream), a Phase 3-ready asset developed for use as a potential therapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. The company’s most advanced Respiratory drug candidate is EB05 (paridiprubart), which is being evaluated in a U.S. government-funded platform study as a treatment for Acute Respiratory Distress Syndrome, a life-threatening form of respiratory failure. The EB05 program has been the recipient of two funding awards from the Government of Canada to support the further development of this asset. In addition to EB05, Edesa is preparing an investigational new drug application (IND) in the United States for EB07 (paridiprubart) to conduct a future Phase 2 study in patients with pulmonary fibrosis. Sign up for news alerts. Connect with us on X and LinkedIn. Edesa Forward-Looking Statements This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "may," "will," "would," "could," "should," "might," "potential," or "continue" and variations or similar expressions, including statements related to: the company’s preparations for a manufacturing campaign of its anti- CXCL10 monoclonal antibody candidate with data anticipated to be submitted to regulators at the FDA during the middle of 2025; the company’s plans to submit data from the planned manufacturing campaign will U.S. regulators as part of an IND application for a Phase 2 study in vitiligo patients; the company’s anticipation that topline results could be available within as few as 12 to 18 months following regulatory clearance in the U.S; the company’s plans for future funding to support the vitiligo development program; the company’s plans to redeploy more resources to its vitiligo drug development program; the company’s goal to be in a position to rapidly launch its vitiligo clinical trial following regulatory clearance; the company’s belief that a targeted immunotherapy, like EB06, that interrupts the disease process on a key point in vitiligo pathogenesis (further downstream from JAK inhibitors) could offer a safe and efficacious treatment; the company’s belief that first quarter results were in line with management’s expectations, and benefited from a subsequent equity financing; the company’s belief that with a stronger balance sheet, which includes $15.0 million in gross proceeds raised in February 2025, the company is well positioned to advance its vitiligo program toward topline data and fund Edesa’s current operating plan; and the company's timing and plans regarding its clinical studies in general. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa's operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa's product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa's ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises. Many of these factors that will determine actual results are beyond the company's ability to control or predict. For a discussion of further risks and uncertainties related to Edesa's business, please refer to Edesa's public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements. Contact:Gary KoppenjanEdesa Biotech, Inc.(289) 800-9600investors@edesabiotech.com Condensed Interim Consolidated Statements of Operations(Unaudited) Three Months Ended December 31, 2024 December 31,2023 Expenses: Research and development 1,019,818 704,458 General and administrative 878,871 1,152,971 Loss from operations (1,898,689) (1,857,429) Other Income (Loss): Reimbursement grant income 301,195 120,834 Other income (loss) (19,759) 58,144 Net loss (1,617,253) (1,678,451) Exchange differences on translation 18,656 (572) Net comprehensive loss $ (1,598,597) $(1,679,023) Weighted average number of common shares 3,345,135 3,128,024 Loss per common share - basic and diluted $ (0.48) $(0.54) Condensed Interim Consolidated Balance Sheets (Unaudited) December 31, 2024 September 30, 2024 Assets: Cash and cash equivalents$ 1,563,502 $1,037,320 Other current assets 508,426 638,302 Non-current assets 2,092,253 2,138,360 Total Assets$ 4,164,181 $3,813,982 Liabilities and shareholders' equity: Current liabilities$ 1,900,219 $1,832,827 Shareholders' equity 2,263,962 1,981,155 Total liabilities and shareholders' equity$ 4,164,181 $3,813,982 Condensed Interim Consolidated Statements of Cash Flows (Unaudited) Three Months Ended December 31, 2024 December 31,2023 Cash flows from operating activities: Net loss$ (1,617,253) $(1,678,451) Adjustments for non-cash items 124,292 229,388 Change in working capital items (24,242) 42,535 Net cash used in operating activities (1,517,203) (1,406,528) Net cash provided by financing activities 2,071,545 305,742 Effect of exchange rate changes on cash and cash equivalents (28,160) 7,176 Net change in cash and cash equivalents 526,182 (1,093,610) Cash and cash equivalents, beginning of period 1,037,320 5,361,397 Cash and cash equivalents, end of period$ 1,563,502 $4,267,787