Edesa Biotech Receives Regulatory Approval for Phase 2 Vitiligo Study

• Company's biologic drug candidate targets a key pathway involved in the progression and maintenance of depigmentation.

TORONTO, ON / ACCESSWIRE / February 1, 2023 / Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that it has received approval from Health Canada for a Phase 2 clinical study of the company's EB06 monoclonal antibody candidate as a treatment for vitiligo.

Vitiligo is a life-altering autoimmune disease that causes skin to lose its color in patches. While it can affect any area, vitiligo commonly occurs on the face, neck and hands, and is a lifelong condition. According to the World Health Organization, vitiligo affects approximately 1% of the world's population.

Par Nijhawan, MD, Chief Executive Officer of Edesa, said that the regulatory clearance of the study represents a key part of the company's development and partnership plans for EB06. "This significant milestone in our vitiligo program provides us another novel Phase 2-ready asset and the opportunity to expand our discussions around partnering and advancing this late-stage biologic asset in our pipeline. Despite the high prevalence of vitiligo, there are few effective treatment options and no approved systemic therapeutics targeting the underlying disease."

Edesa's drug targets autoreactive T cells that destroy the pigment-producing cells of the epidermis. Specifically, EB06 binds to chemokine ligand 10 (CXCL10) and inhibits the interaction of CXCL10 with its receptor(s). CXCL10 is highly expressed in vitiligo patients in both skin and serum, and CXCL10 is implicated in both the initiation of the disease and the maintenance of vitiligo lesions. Results from 65 subjects in three previous clinical studies demonstrated that EB06 produced the pharmacodynamic /biological activity required to address the dysfunctional immune response associated with vitiligo, and was generally safe and well tolerated. Preclinical studies have also demonstrated that neutralization of CXCL10 prevented and reversed depigmentation.

"We believe there is significant scientific rationale to evaluate EB06's potential to prevent and reverse the highly visible symptoms of vitiligo, and we are excited about the potential of this program to change people's lives," said Dr. Nijhawan.

As planned, the Phase 2 study protocol approved by Health Canada will evaluate the safety and efficacy of EB06 versus placebo in adults with moderate to severe non-segmental (generalized) vitiligo. Patients will receive intravenous infusions of either EB06 or placebo during the treatment period, followed by a follow-up period. Approximately 120 adult subjects will be included in the double-blind, placebo-controlled study at up to approximately 25 investigational centers in Canada. The primary endpoint will be improvement from baseline on the Face Vitiligo Area Scoring Index (F-VASI), a quantitative clinical tool that estimates the overall area of vitiligo patches and the degree of macular re-pigmentation within these patches over time.

About Edesa Biotech
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. 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 company's belief that the CTA approval is a significant milestone and provides it with the opportunity to expand its discussions around partnering and advancing EB06; the potential efficacy of the drug in treating vitiligo and the relevance of EB06's mechanism of action against CXCL10; the company's belief that there is significant scientific rationale to evaluate EB06's potential to both prevent and reverse the highly visible symptoms of vitiligo; the drug's potential ability to change people's lives; and the company's timing and plans regarding its clinical development programs 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 ext. 150
investors@edesabiotech.com

SOURCE: Edesa Biotech