DICE Therapeutics Initiates Phase 1 Clinical Trial of S011806 for the Treatment of Psoriasis
DICE Therapeutics (Nasdaq: DICE) announced the dosing of the first healthy volunteer in its Phase 1 clinical trial for S011806, an oral antagonist targeting IL-17, on October 25, 2021. This first-in-human trial aims to evaluate the safety, pharmacokinetics, and early efficacy of S011806 in psoriasis patients. With over 8 million Americans suffering from psoriasis, this trial represents a significant milestone in developing oral therapies for IL-17 mediated diseases. Successful outcomes could lead to S011806 becoming a viable alternative to injectable biologics.
- Initiation of Phase 1 clinical trial for S011806, marking a key milestone.
- Potential to provide an effective oral treatment option for psoriasis patients.
- Development targets a validated drug pathway with the IL-17 antagonist.
- The trial's outcome is uncertain, with no guarantee of success.
- Regulatory approval and commercialization remain significant hurdles.
SOUTH SAN FRANCISCO, Calif., Oct. 25, 2021 (GLOBE NEWSWIRE) -- DICE Therapeutics, Inc. (Nasdaq: DICE), a biopharmaceutical company leveraging its proprietary technology platform to build a pipeline of novel oral therapeutic candidates to treat chronic diseases in immunology and other therapeutic areas, today announced that the first healthy volunteer has been dosed in the Company’s Phase 1 clinical trial of S011806. S011806 is an orally-available, small molecule antagonist of the pro-inflammatory cytokine, interleukin-17 (IL-17), which is a validated drug target for the treatment of a variety of immunological diseases. The Phase 1 trial of S011806 is designed to generate safety and pharmacokinetic data, as well as provide early clinical proof-of-concept in psoriasis patients.
“S011806 is designed to be a highly selective and potent orally administered inhibitor of the IL-17 cytokine, a well-validated target in psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondylarthritis,” said Kevin Judice, Ph.D., founder and CEO of DICE Therapeutics. “The initiation of this clinical trial for S011806, the first of several programs in our IL-17 franchise, marks a major milestone in our mission to bring an effective and convenient oral therapy to patients suffering from IL-17 mediated diseases like psoriasis.”
The Phase 1 clinical trial is a first-in-human, randomized, double-blind, placebo-controlled study that will evaluate S011806 in healthy volunteers and psoriasis patients in the UK. The trial will evaluate single and multiple ascending doses in healthy volunteers to understand the safety and pharmacokinetics of S011806. In addition, the Phase 1 clinical trial will evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of S011806 across two dose regimens in psoriasis patients, which could provide early clinical proof-of-concept and dose selection guidance for use in future studies.
About S011806 and Psoriasis
S011806 is an orally available, small molecule antagonist of the pro-inflammatory signaling molecule IL-17, an immune cell-derived cytokine that is produced in response to infection by certain microorganisms. Upon binding to its receptor on various cell types found in tissues (e.g. keratinocytes, fibroblasts, and epithelial cells), IL-17 elicits downstream signals that orchestrate sustained tissue inflammation, with the aim of clearing the invading pathogen.
In autoimmune diseases, the immune system appears to over-react and mount strong immune responses in the absence of an obvious infectious event. Over the past two decades, research has shown that IL-17 is a powerful driver of psoriasis, a skin disease that occurs in the absence of an obvious infectious event. Psoriasis manifests as erythematous plaques with thick scaling that can occur anywhere on the body. Symptoms include itching, bleeding, and pain; furthermore, the disease can lead to disfiguration and considerable psychological burden. According to the National Psoriasis Association, more than eight million Americans – and 125 million people worldwide – suffered from psoriasis in 2020. There is no cure for psoriasis.
S011806 is being developed initially for the treatment of psoriasis, with the objective of achieving therapeutic benefit similar to that of the U.S. FDA-approved injectable biologics.
About DICE Therapeutics, Inc.
DICE Therapeutics, Inc. is a biopharmaceutical company leveraging its proprietary technology platform to build a pipeline of novel oral therapeutic candidates to treat chronic diseases in immunology and other therapeutic areas. DICE is initially focused on developing oral therapeutics against well-validated targets in immunology, with the goal of achieving comparable potency to their systemic biologic counterparts, which have demonstrated the greatest therapeutic benefit to date in these disease areas. The Company’s DELSCAPE platform is designed to discover selective oral small molecules with the potential to modulate protein-protein interactions (PPIs) as effectively as systemic biologics. DICE’s lead therapeutic candidate, S011806, is an oral antagonist of the pro-inflammatory signaling molecule, IL-17, which is a validated drug target implicated in a variety of immunology indications. DICE is also developing oral therapeutic candidates targeting α4ß7 integrin and αVß1/αVß6 integrin for the treatment of inflammatory bowel disease and idiopathic pulmonary fibrosis, respectively.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the current beliefs and expectations of management. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning the Company’s future plans and prospects, and the planned timing of the Company’s dosing and further clinical development of S011806. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to the Company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in our forward-looking statements due to a variety of factors, including risks and uncertainties related to our ability to advance S011806 and our other therapeutic candidates, obtain regulatory approval of and ultimately commercialize our therapeutic candidates, the timing and results of preclinical and clinical trials, our ability to fund development activities and achieve development goals, the impact of the COVID-19 pandemic on our business, our ability to protect intellectual property and other risks and uncertainties described under the heading “Risk Factors” in our final prospectus filed with the Securities and Exchange Commission (SEC) pursuant to Rule 424(b)(4) on September 16, 2021, and our other SEC filings. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein.
Contact:
Katie Engleman, 1AB
katie@1abmedia.com
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