Edesa Biotech Announces Promising Phase 2b Results for Innovative Dermatology Drug

Researchers have been able to pinpoint the lowest effective dose of a medication or therapy, thanks to a successful study. This breakthrough provides an invaluable tool for medical professionals and could potentially revolutionize the way treatments are prescribed.

A recent clinical trial has revealed that a 1.0% formulation has successfully achieved its primary endpoint with a statistically significant result. This is a major breakthrough that could potentially revolutionize the field and provide a new, more effective solution for the issue.

A groundbreaking clinical trial has just revealed a remarkable breakthrough: a 1.0% formulation has successfully achieved its primary endpoint with a highly significant result. This remarkable outcome could revolutionize the field, providing a new and more effective solution to the issue at hand. It is a major milestone in the quest for a better solution.

Edesa Biotech, Inc. (NASDAQ:EDSA) is thrilled to announce the promising preliminary results of a Phase 2b clinical study evaluating the efficacy of EB01, its drug candidate for moderate-to-severe chronic Allergic Contact Dermatitis (ACD), as a monotherapy. The results of this study represent an exciting step forward in the development of EB01 as a potential treatment for this debilitating inflammatory and immune-related condition.

We are delighted to present the promising preliminary results of a Phase 2b clinical study of EB01, our innovative drug candidate for the treatment of moderate-to-severe chronic Allergic Contact Dermatitis (ACD). This exciting step forward in the development of EB01 has the potential to provide desperately needed relief to those suffering from this debilitating inflammatory and immune-related condition.

Edesa’s 1.0% EB01 cream has been proven to be significantly more effective than placebo in improving skin condition. Over the course of the trial, patients with 1.0% EB01-treated lesions demonstrated an average improvement of 60% in symptoms from baseline at day 29 on the CDSI, compared to just 39% for placebo/vehicle (p=0.02). This effect was also observed at 15 days (44% for 1.0% EB01 vs 29% for placebo; p=0.05) and continued at follow-up (64% for 1.0% EB01 vs. 44% for placebo; p=0.04). Moreover, 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=0.04), compared to just 29% of patients in the placebo group. Notably, no serious treatment-related adverse events were reported across all concentrations. The 2.0% and 0.2% formulations did not show significant differences compared to placebo.

We are delighted to announce that the recently conducted study showed that 1.0% EB01 cream was effective in reducing symptoms of moderate-to-severe allergic contact dermatitis for more than half of the participants. Not only did the patients see significant improvement in as little as two weeks, but the treatment also had a powerful anti-inflammatory effect. With these positive findings, we are confident that EB01 could become the standard of care for patients with chronic allergic contact dermatitis.

The topline results of the clinical study revealed that the 1.0% concentration of the product was the most efficacious dose, outperforming placebo, and even surpassing the highest concentration that the company had anticipated. This is a major breakthrough, as it not only provides an effective treatment option, but also promises much lower costs of goods due to the lower concentration.

Edesa is eagerly anticipating an End of Phase 2 meeting with the FDA after completing a thorough analysis of their Phase 2b data, which is projected to be finalized by the middle of the year.

About Allergic Contact Dermatitis

Contact dermatitis, a common yet costly occupational health issue in the United States, has been estimated to cost up to $2 billion each year. Symptoms, which range from irritation and redness to open sores, are caused by an allergen that interacts with the skin, typically on the hands and face. Unfortunately, in many ongoing cases, the allergen remains unidentified or difficult to avoid due to the vast number of substances known to cause contact allergies, which total to over 3,000.

About Edesa Biotech

Edesa Biotech, Inc. (NASDAQ:EDSA) is on an exciting mission to develop groundbreaking new treatments for inflammatory and immune-related diseases. Our two lead product candidates, EB05 and EB01, are in late-stage clinical trials, bringing us one step closer to making a positive impact on patients’ lives.

Discover relief from chronic allergic contact dermatitis (ACD) with EB01, a powerful non-steroidal anti-inflammatory compound that inhibits secretory phospholipase 2 (sPLA2). Our innovative clinical program is committed to providing the best care and treatment for those suffering from ACD.

Edesa’s revolutionary EB01 vanishing cream is a game-changer in treating inflammatory/allergic conditions. By targeting the inflammatory enzyme sPLA2, EB01 has been clinically proven to provide powerful anti-inflammatory relief. This innovative treatment has already been successful in two clinical trials for ACD, as well as showing successful results in preclinical models. EB01 is a revolutionary approach for treating inflammation, targeting the root cause at the very start of the inflammatory process.

Introducing EB05, a groundbreaking monoclonal antibody therapy for Acute Respiratory Distress Syndrome (ARDS). By targeting Toll-like Receptor 4 (TLR4), EB05 has the potential to provide much-needed relief to critically ill patients. Currently, we are enrolling participants for our Phase 3 clinical program to evaluate the safety and efficacy of this novel therapy.

TLR4 is an important pattern recognition receptor involved in the activation of the innate immune system, but when its signal pathway is overactivated, it can cause serious inflammatory conditions like viral-mediated acute lung injury. Fortunately, EB05 has been found to inhibit this pathway, providing a potential solution to many of these health issues.

EB05, a promising new drug, has been extensively studied preclinically and clinically, with over 600 hospitalized Covid-19 patients evaluated. In a Phase 2 study, a single dose of EB05 showed remarkable results in reducing mortality in critically ill Covid-19 patients; when compared to a placebo plus standard of care treatment, patients given EB05 plus standard of care treatment had an astonishing 84% reduction in the risk of dying at 28 days.

Cautionary Note Regarding Clinical Studies

The preliminary results of the Phase 2b study are in, but further analysis is required to uncover the full picture. While these topline results provide an interesting insight, they should not be taken as the complete, final or definitive findings of the study. Stay tuned for more updates as the analysis progresses.

Edesa Forward-Looking Statements

Edesa is pleased to announce the successful results of its Phase 2b clinical trial for its anti-inflammatory drug, EB01. The topline results from the 1% arm of the study indicate that EB01 could become a standard of care treatment option for patients living with chronic allergic contact dermatitis. Not only is the 1% dose showing promising results, but it could also provide significant cost savings. Edesa plans to have an End of Phase 2 meeting with the FDA following full analysis of the data, which is expected to be completed by midyear. The company believes that the anti-inflammatory technology used in EB01 could open up a powerful therapeutic strategy for treating a range of other inflammatory/allergic conditions. With these promising results, Edesa is confident that it can achieve its goal of bringing EB01 to market and providing a much-needed treatment option to those suffering from chronic allergic contact dermatitis.

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