Exicure Announces Top-line Patient Data for Phase 1 Inflammation Program in Psoriasis
Exicure, Inc. (OTCQB:XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA™) constructs, announced today top-line results from a Phase 1 clinical trial evaluating XCUR17 in patients with mild-to-moderate chronic plaque psoriasis. XCUR17 is an SNA drug targeted to mRNA encoding interleukin 17 receptor alpha, or IL-17RA. IL-17RA is a key protein that propagates inflammation. In preclinical studies, XCUR17 inhibited IL-17RA expression in human skin and in psoriatic mouse models.
Exicure’s Phase 1 Trial Results
“We are pleased to announce the first clinical benefits of our SNA platform in patients,” said Dr. David Giljohann, CEO. “This is a milestone for our SNA platform and for our mission to create a new class of locally-applied, genetically-targeted drugs. Findings from this Phase 1 trial suggest that SNA-based drugs, such as XCUR17, may address clinical symptoms in patients with inflammatory diseases such as psoriasis.”
The Phase 1 clinical trial, which had final patient visits in the fourth quarter of 2018, was a randomized, double-blinded, placebo-controlled trial in twenty-one patients with mild to moderate chronic plaque psoriasis designed to assess the safety of XCUR17 formulated as a topical gel, and to evaluate early signs of efficacy. All patients received three strengths of XCUR17 gel, a vehicle gel, and a positive comparator (Daivonex® cream), which were all applied on different areas of psoriatic skin within each individual patient. Seventeen of the twenty-one patients treated with the positive comparator showed a clinical response, while four patients treated with the placebo vehicle had a clinical response.
In the case of XCUR17, of the twenty-one treated patients, eleven treated with the highest strength XCUR17 gel were observed to have a reduction in redness and improvement in healing as determined by blinded physician assessments. Further, the highest strength XCUR17 gel showed a statistically significant improvement in psoriasis symptoms versus the vehicle gel.
There were no adverse safety events related to treatment with XCUR17 observed. In addition to the safety, tolerability and clinical assessments, the trial measured psoriatic infiltrate thickness over the 26-day treatment period. No relevant changes in mean psoriatic infiltrate thickness were observed for the three XCUR17 gels or the active ingredient-free vehicle gel. At this time, assessments of IL-17RA mRNA levels from skin biopsies collected from the treated areas in patients have not yet been correlated with the clinical or infiltrate thickness assessments. Analysis of skin biopsy histology and analysis of mRNA targets in the psoriasis network are underway.
“The clinical data for XCUR17 marks a major step as we seek to progress our platform in local gene regulation therapies, not just in dermatology, but also in neurology, ophthalmology, and gastroenterology,” added Dr. Giljohann.
About Exicure, Inc.
Exicure, Inc. is a clinical stage biotechnology company developing a new class of immunomodulatory and gene regulating drugs against validated targets. Exicure's proprietary spherical nucleic acid (SNA™) architecture is designed to unlock the potential of therapeutic oligonucleotides in a wide range of cells and tissues. Exicure's lead programs address inflammatory diseases, genetic disorders and oncology. Exicure is based outside of Chicago, IL. www.exicuretx.com
Forward Looking Statements
This press release contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning the Company, the Company’s technology, potential therapies and other matters. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “believe,” “intend,” “look forward,” and other similar expressions among others. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: unexpected costs, charges or expenses that reduce cash runway; that many drug candidates that have completed Phase 1 trials do not become approved drugs on a timely or cost effective basis or at all; possible safety and efficacy concerns; regulatory developments; and the ability of Exicure to protect its intellectual property rights. XCUR17 is in early stage of clinical development, and the process by which XCUR17 could potentially lead to an approved therapeutic is long and subject to significant risks, unknowns, and uncertainties. Risks facing the Company and its programs are set forth in the Company’s filings with the SEC. Except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
View source version on businesswire.com: https://www.businesswire.com/news/home/20181217005225/en/