TORONTO, ON / ACCESSWIRE / June 3, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that the company's drug candidate EB01 has met a key interim study parameter. The company has now passed the initial inflection point of its Phase2b study and will continue enrolling the final cohort of patients.
Edesa reported that interim study data from the first cohort met statistical thresholds previously approved by the U.S. Food and Drug Administration as part of an adaptive Phase 2b trial evaluating EB01 as a monotherapy for moderate to severe chronic Allergic Contact Dermatitis (ACD). Though blinded to treatment assignment, the study's Data and Safety Monitoring Board (DSMB) reported an approximately 1.7-fold difference between the treatment arms for the primary efficacy endpoint, which is the mean percent change from baseline on the Contact Dermatitis Severity Index (CDSI) at day 29.
Likewise, the DSMB reported an approximately 1.8-fold difference between the treatment arms in the proportion of patients achieving success on the ISGA (Investigator's Static Global Assessment), a key secondary efficacy endpoint. Success on the ISGA is defined as a two-point reduction from baseline and a final ISGA score of '0' or '1' indicating clear or almost clear skin, respectively. A decrease in score relates to an improvement in signs and symptoms. For both the CDSI and ISGA endpoints, double-digit absolute differences were observed among the two treatment arms. No serious treatment-related adverse events were reported for either treatment group.
Based on these findings, the DSMB has recommended progression to the second cohort of patients. Interim study data is preliminary and full study results are subject to change; and since the analysis remains blinded, it is not possible to definitively conclude if EB01 may be outperforming placebo or vice versa. The initial cohort analyzed consisted of a population of 46 subjects, of whom 36 completed the study follow-up and were used in the interim analysis. As of June 2, 2021, 66 total patients (including the first cohort) have been randomized in the Phase 2b study.
"This milestone represents a significant step in our plans to develop an effective and safe treatment option for chronic ACD patients. Although blinded, these results are highly encouraging and we are excited to move into the final phase of the study," said Dr. Par Nijhawan, Chief Executive Officer of Edesa. "I would like to thank the patients, physicians and research staff for enabling us to reach this important milestone and we are encouraged by the ongoing interest in the novel mechanism of action employed by EB01."
Blair Gordon, PhD, Vice President of Research and Development, said that based on the interim findings and the safety monitoring board's recommendations, Edesa will continue with an additional cohort of at least 120 evaluable subjects, who will be provided with either Edesa's EB01 topical treatment (at a 2.0%, 1.0% and 0.2% concentration) or a placebo cream. The company is also evaluating a potential open-label extension for study patients.
"We are excited to see meaningful early signals between the treatment arms for both the CDSI and ISGA interim endpoints. Now that we are beyond the futility cut-off hurdle, we are fine-tuning the final subject population to be in the best position to demonstrate unequivocal results for both these endpoints, which will be important for Phase 3 trial design," said Dr. Gordon.
EB01 cream contains a non-steroidal anti-inflammatory compound known as an sPLA2 (secretory phospholipase-2) inhibitor. Since EB01 is designed to inhibit the inflammatory process at its inception rather than after inflammation has occurred, the company believes that the drug could potentially exert a powerful anti-inflammatory effect without the safety concerns of steroids. In two previous clinical studies EB01 has demonstrated statistically significant improvement of multiple symptoms in ACD patients.
Contact dermatitis, which can be either irritant contact dermatitis or ACD, 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 as a result of lost work, reduced productivity, medical care and disability payments. Edesa estimates that there are more than 2.5 million people in the U.S. with allergic contact dermatitis, with academic literature pointing to a potentially larger undiagnosed population. More than one million patients are estimated to have chronic ACD. To the company's knowledge there are currently no treatment options specifically labelled for ACD.
JSS Medical Research is acting as Edesa's contract research organization for the Phase 2b study. Physicians interested in participating in the study should contact [email protected] or visit www.clinicaltrials.gov (Identifier: NCT03680131).
About Edesa Biotech, Inc.
Edesa Biotech, Inc. (Nasdaq:EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. The company's two lead product candidates, EB05 and EB01, are in later stage clinical studies. EB05 is a monoclonal antibody therapy that we are developing as a treatment for Acute Respiratory Distress Syndrome (ARDS). ARDS is a life-threatening form of respiratory failure, and the leading cause of death among COVID-19 patients. Edesa is also developing an sPLA2 inhibitor, designated as EB01, as a topical treatment for chronic allergic contact dermatitis (ACD), a common, potentially debilitating condition and occupational illness. 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. The company is based in Markham, Ontario, Canada, with a U.S. subsidiary located in Southern California. Sign up for news alerts.
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 plans regarding its Phase 2b clinical study, the company's belief that data from the full study population will demonstrate statistical significance, plans to adjust subject population to be in the best position to demonstrate unequivocal results for both for the CDSI and ISGA endpoints, and the company's belief that EB01 could potentially exert a powerful anti-inflammatory effect without the safety concerns of steroids. 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.
Edesa Biotech, Inc.
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SOURCE: Edesa Biotech