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While wound dressings and wound closure devices play an important role in postoperative care, serious injuries as a result of the synthetic adhesives found in these products can often cause more harm than good. Medical Adhesive Related Skin Injuries (MARSI) affect over 1.5 million patients each year and are a leading cause of painful postoperative complications including delayed wound healing, surgical site infections (SSIs) and poor scarring outcomes. MARSIs are often underreported in medicine, highlighting the critical need for increased awareness and improved preventive measures to address this important patient safety concern. How do medical adhesive related skin injuries (MARSIs) occur? MARSIs occur as a result of the improper selection, application or removal of medical adhesives, tapes, or dressings. Skin rashes to medical adhesives can occur up to two weeks after their application and are often underreported by healthcare professionals. The last thing patients should have to worry about after surgery is dealing with additional complications caused by the very products meant to aid their recovery. Unfortunately, these complications do not have a standardized method for their prevention, reporting or treatment. A survey of 918 wound care health professionals in 2016 found that MARSI was not reported in their facility 71% of the time and only 31% of respondents were aware of the term. Educating both clinicians and patients regarding MARSIs and highlighting the importance of wound dressing selection are crucial measures to mitigate these postoperative complications. These complications lead to the disruption of the epidermal barrier which cause delayed wound healing, inflammation, irritation and increase the susceptibility of the wound to outside pathogens which can cause infections. Common complications as a result of MARSIs Adverse events as a result of medical adhesive related skin injuries fall into the following categories: Allergic Contact Dermatitis: A skin hypersensitivity reaction to the adhesive or dressing material which causes a rash that may either be localized to the area of exposure or go beyond. Irritant Contact Dermatitis: non-allergic contact dermatitis a result of a chemical irritant that occurs in a localized area correlated to the area of exposure. Tension Injury or Blister: Separation of the epidermis from the dermis as a result of shear forces that occur when a medical tape or dressing is applied in an area with tension or movement. Often results in blister formation. Skin Tear: Removal of one or multiple layers of the skin as a result of dressing or tape removal. Maceration: Injury as a result of moisture being trapped against the skin for extended periods of time resulting in the softening and disruption of the skin. Prevalence of MARSIs A recent study published in the Aesthetic Surgery Journal Open Forum in collaboration with the Johns Hopkins University School of Medicine and the University of California San Diego found that current synthetic devices such as the Dermabond Prineo Skin Closure System display a range of adverse events associated with MARSI. The study found the rate of severe allergic contact dermatitis to Dermabond Prineo to be 24% (6/25) which a moderate rate of 52% (13/25) in comparison to a 0% (0/25) reaction rate to a natural silk fibroin dressing. The silk dressing significantly decreased skin discomfort (4% vs. 64%) and reduced the need for topical steroids or antibiotics for the treatment of ACD and SSIs (0% vs. 52%). A prospective study in adult intensive care units found the rate of MARSI to be 42% (n=150) while another prospective cohort study found the rate to be 60.3% (n=136) in congenital heart surgery. The rise of synthetic compounds and materials in modern medicine may be associated with this increase in MARSI reported in the literature. Despite these reports, the true rate of MARSI remains uncertain due to the lack of standardized reporting and awareness of the issue in healthcare facilities. Which patients are at the highest risk for MARSI? Infants and elderly patients are at a higher risk for MARSI due to their delicate and fragile skin which can be hypersensitive to irritants and can be easily damaged by adhesive dressing removal. Patients who are dehydrated or malnourished are also at higher risk due to the lack of moisture and nutrients required for skin integrity. Underlying medical conditions which can also affect the skin include diabetes, infection, renal insufficiency, and immunosuppression. Individuals with dermatological conditions such as eczema and psoriasis which can cause dry and flaky skin are also at increased risk for MARSI. The relation between MARSI and surgical site infections The skin is the largest organ of our bodies and serves as the main protective barrier against the outside world and pathogens. After a surgical procedure the role of wound closures and dressings is to promote the natural healing process to allow the regeneration of the damaged tissue. A MARSI serves as a direct disruption to this process and can delay wound healing for weeks to months after the initial procedure. Contact dermatitis, blistering, and skin tearing cause the epidermis to detach from the dermis, leading to prolonged inflammation and an increased risk of Surgical Site Infections (SSIs). SSIs can cost up to $29,000 per incident and increase hospitalization stays an additional 7 to 11 days longer. They also incur cumulative costs of up to $10 billion annually. Reducing the prevalence of MARSIs are crucial in minimizing the serious dangers and costs associated with SSIs. Treatment and preventative measures against MARSI The selection of the correct wound dressings and closure devices for patients remains an important factor in preventing MARSIs. Clinicians should consider patient risk factors, skin integrity, patient allergies and the location of the wound. Improper removal techniques can lead to mechanical skin tears. Adhesive dissolvers may be utilized to mitigate this concern. Leaving on occlusive dressings for extended periods of time may also result in MARSI.

1.0% Formulation Reached Primary Endpoint with Statistical Significance Full Analysis Identified Additional Efficacy Signals TORONTO, ON / ACCESSWIRE / November 20, 2023 / Edesa Biotech, Inc., (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced favorable final results from a Phase 2b dose-ranging clinical study of the company's drug candidate, EB01 (daniluromer), as a monotherapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD). Edesa reported that final data confirmed previous topline findings that 1.0% EB01 cream demonstrated statistically significant improvement over placebo. For the primary endpoint, patients with 1.0% EB01-treated lesions demonstrated a 60% average improvement in symptoms from baseline at day 29 on the Contact Dermatitis Severity Index (CDSI) versus 40% for placebo/vehicle (p=0.027). For the ISGA secondary efficacy endpoint, 53% of patients with 1.0% EB01-treated lesions achieved a score of "clear" or "almost clear" with at least a 2-point improvement from baseline after treatment at day 29 (p=0.048). Only 29% of patients in the placebo group reached the same endpoint. For other dose formulations, no material changes to previously reported topline efficacy results were identified. No serious treatment-related adverse events were reported across all dose formulations. In addition, analysis of the full dataset demonstrated that patients receiving 1.0% EB01 (daniluromer) experienced improvement across each component symptom of the CDSI score, including redness (50% reduction for EB01 vs. 35.4% placebo; p=0.17), pruritis/itching (60.5% reduction for EB01 vs. 41.3% placebo; p=0.06), fissures (63.1% reduction for EB01 vs. 44.3% placebo; p=0.02), scaling (58.3% reduction for EB01 vs. 42.9% placebo; p=0.36), and dryness (62.9% reduction for EB01 vs. 35.9% placebo; p=0.02). The final data also demonstrated that the Body Surface Area (BSA) of 1.0% EB01-treated lesions was reduced by 42.1% on average at day 29 compared to a 8.8% reduction for placebo/vehicle (p=0.054). "We are thrilled to announce the positive final clinical study results for 1.0% EB01 cream, which not only confirm our previous data but also provided important new insights into the efficacy of our first-in-class drug candidate," said Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech. "This significant milestone puts us in position to advance potential partnership discussions and ultimately brings us one step closer to delivering potentially life-changing solutions to patients with moderate to severe, chronic allergic contact dermatitis." About the Phase 2b Study Edesa's double-blind, placebo-controlled Phase 2b trial evaluated the safety and efficacy of EB01 (daniluromer) in approximately 200 subjects, who were treated for 28 days with either EB01 cream (2.0%, 1.0% or 0.2%) or a placebo/vehicle cream. The primary efficacy outcome measurement was the mean percent improvement in symptoms from baseline at day 29 on the Contact Dermatitis Severity Index (CDSI). A key secondary efficacy measurement was the success rate of subjects achieving a score of "clear" or "almost clear" with at least a 2-point improvement from baseline after treatment at day 29 on the Investigator's Static Global Assessment (ISGA) scale. About Daniluromer Daniluromer is a first-in-class, non-steroidal anti-inflammatory compound that inhibits secretory phospholipase 2 (sPLA2) pro-inflammatory enzymes. The sPLA2 enzyme family plays a key role in initiating inflammation associated with numerous diseases. By targeting sPLA2 with enzyme inhibitors - at the inception of inflammation rather than after inflammation has occurred - Edesa believes that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory/allergic conditions. EB01 (topical daniluromer) has demonstrated efficacy for the treatment of ACD in two previous clinical trials, and has demonstrated anti-inflammatory activity in a variety of in vitro and in vivo preclinical pharmacology models. About Allergic Contact Dermatitis Contact dermatitis, which can be either irritant contact dermatitis or ACD (sometimes called allergic contact eczema), is one of the most common occupational health illnesses in the United States. The disease has been estimated to cost up to $2 billion annually in the U.S. as a result of lost work, reduced productivity, medical care and disability payments. The condition is caused by an allergen interacting with skin, usually on the hands and face. Inflammation can vary from irritation and redness to open sores, and in many chronic cases, the causative allergen is unknown or difficult to avoid. Approximately 3,000 substances are recognized as contact allergens. 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. The company's most advanced drug candidate is EB05 (paridiprubart), a monoclonal antibody developed for acute and chronic disease indications that involve dysregulated innate immune responses. Edesa is currently evaluating EB05 in a Phase 3 study as a potential treatment for Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure. In addition, Edesa is developing an sPLA2 inhibitor, EB01 (daniluromer), as a topical treatment for chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. The company has also received regulatory approval to conduct a Phase 2 trial of its EB06 monoclonal antibody as a treatment for vitiligo, a life-altering autoimmune disease that causes skin to lose its color in patches. Edesa is also planning to investigational new drug application for a future Phase 2 study of paridiprubart for systemic sclerosis (scleroderma), an autoimmune rheumatic disorder that causes fibrosis, (scarring/hardening) of skin and internal organs such as the lungs, heart and kidneys. Sign up for news alerts. Connect with us on X (Twitter) 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 determination that the final Phase 2b study data not only confirmed previous topline data but also provided important new insights into the efficacy of its first-in-class drug candidate; the company's belief that the final study report and data represent a significant milestone; the company's belief that final Phase 2b data puts the company in position to advance potential partnership discussions and ultimately brings Edesa one step closer to delivering potentially life-changing solutions to patients with moderate to severe, chronic allergic contact dermatitis; 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 Koppenjan Edesa Biotech, Inc. (289) 800-9600 investors@edesabiotech.com SOURCE: Edesa Biotech View source version on accesswire.com:

TORONTO, ON / ACCESSWIRE / March 16, 2023 / Edesa Biotech, Inc. announced today that the company has been selected to present clinical trial data from a Phase 2B multi-dose study of its EB01 drug candidate at a Late Breaking Abstract session of the American Academy of Dermatology Association (AAD) annual meeting being held March 17-21, 2023. The presentation will detail the statistically significant topline results achieved by 1.0% EB01 cream in moderate-to-severe chronic allergic contact dermatitis (ACD) subjects, as well as data from other dose concentrations and safety data. Session Date and Time: March 18, 2023, 2:50 pm Central Time Abstract Title: A Randomized, Double-Blind, Vehicle-Controlled, Sample Size Adaptive Design Study to Evaluate the Safety and Efficacy of Topically Applied EB01 Cream in Adult Subjects with Moderate-to-Severe Chronic Allergic Contact Dermatitis Presenting Author: Blair Gordon, PhD Presentation slides will be available shortly after the event in the Events section of Edesa's website. About EB01 EB01 is a non-steroidal anti-inflammatory compound that inhibits secretory phospholipase 2 (sPLA2) pro-inflammatory enzymes. The sPLA2 enzyme family plays a key role in initiating inflammation associated with numerous diseases. By targeting sPLA2 with enzyme inhibitors - at the inception of inflammation rather than after inflammation has occurred - Edesa believes that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory/allergic conditions. EB01 has demonstrated efficacy for the treatment of ACD in two previous clinical trials, and has demonstrated anti-inflammatory activity in a variety of in vitro and in vivo preclinical pharmacology models. About Allergic Contact Dermatitis (ACD) Contact dermatitis, which can be either irritant contact dermatitis or ACD (sometimes called allergic contact eczema), is one of the most common occupational health illnesses in the United States. The disease has been estimated to cost up to $2 billion annually in the U.S. as a result of lost work, reduced productivity, medical care and disability payments. The condition is caused by an allergen interacting with skin, usually on the hands and face. Inflammation can vary from irritation and redness to open sores, and in many chronic cases, the causative allergen is unknown or difficult to avoid. Approximately 3,000 substances are recognized as contact allergens. About Edesa Biotech Edesa Biotech, Inc. (Nasdaq:EDSA) is a clinical-stage biopharmaceutical company developing innovative ways to treat inflammatory and immune-related diseases. The company's most advanced drug candidate is EB05, a monoclonal antibody developed for acute and chronic disease indications that involve dysregulated innate immunity responses. Edesa is currently evaluating EB05 in a Phase 3 study as a potential treatment for Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure. In addition, Edesa is developing an sPLA2 inhibitor, EB01, as a topical treatment for chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. The company has also received regulatory approval to conduct a Phase 2 trial its EB06 monoclonal antibody as a treatment for vitiligo, a life-altering autoimmune disease that causes skin to lose its color in patches. The company is also planning to investigational new drug application for a future Phase 2 study of its anti-TLR4 monoclonal antibody for Systemic Sclerosis (Scleroderma), an autoimmune rheumatic disorder that causes fibrosis, (scarring/hardening) of skin and internal organs such as the lungs, heart and kidneys. Sign up for news alerts. Connect with us on Twitter 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 efficacy and safety of EB01 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, such as Covid-19. 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 Koppenjan Edesa Biotech, Inc. (805) 488-2800 investors@edesabiotech.com SOURCE: Edesa Biotech View source version on accesswire.com: