DICE Therapeutics Announces Positive Topline Data from Phase 1 Clinical Trial of Lead Oral IL-17 Antagonist, DC-806, for Psoriasis
October 11, 2022 at 07:00 AM EDT
Clinical proof-of-concept in psoriasis patients achieved with a mean percentage reduction in PASI from baseline at 4 weeks of 43.7% in the high dose group compared to 13.3% in the placebo group, with an exploratory p-value of 0.0008
DC-806 was well tolerated with an excellent safety profile across all dose groups in healthy volunteers and psoriasis patients with a robust PK profile and clear pharmacodynamic effects on two distinct biomarkers at both high and low doses of DC-806
Data supports further development of DC-806 as potential best-in-class oral agent for psoriasis; DC-806 is expected to advance into a Phase 2b clinical trial in the first half of 2023
Company to host conference call and webcast today at 8:00 a.m. ET
SOUTH SAN FRANCISCO, Calif., Oct. 11, 2022 (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 positive topline data from its Phase 1 clinical trial of DC-806, an oral small molecule antagonist of the pro-inflammatory cytokine IL-17. The trial was a first-in-human, randomized, double-blind, placebo-controlled study designed to generate safety and pharmacokinetic (PK) data in healthy volunteers as well as provide early clinical proof-of-concept in psoriasis patients. The trial was conducted in three overlapping parts: Phase 1a single ascending dose (SAD) (n=40); Phase 1b multiple ascending dose (MAD) (n=32); and Phase 1c proof-of-concept in psoriasis patients (n=32).
“We are extremely excited by the overall clinical profile of DC-806 and clear proof-of-concept in psoriasis in this Phase 1 clinical trial, which we believe is the first ever clinical demonstration of direct inhibition of a cytokine with a small molecule,” said Kevin Judice, Ph.D., CEO of DICE Therapeutics. “We believe these data not only support further development of DC-806 as a potential best-in-class oral therapy for psoriasis, but also may unlock additional IL-17-mediated disease indications given DC-806’s excellent safety profile, strong PK data, and robust, dose-dependent target engagement. More broadly, we believe these data validate our DELSCAPE platform as we work to advance more oral small molecule therapeutics to address other validated protein-protein interaction targets in immunology and other therapeutic areas.”
“Based on the Phase 1 clinical trial, we believe DC-806 has the potential to be the best-in-class oral therapeutic agent for patients with psoriasis,” said Tim Lu, M.D., Ph.D., chief medical officer of DICE Therapeutics. “There is a clear need for safe and more effective oral therapies for chronic immunological diseases like psoriasis. Data from this Phase 1 clinical trial provide early evidence for the potential differentiation of DC-806 on efficacy, safety, and ease of use. We look forward to advancing DC-806 into a Phase 2b clinical trial to optimize dosing and further explore peak efficacy with a longer duration of treatment.”
Conference Call and Webcast Information
About the DICE Oral IL-17 Franchise and Psoriasis
In autoimmune diseases, the immune system appears to overreact 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 the skin disease psoriasis. 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.
The therapeutic candidates in DICE’s oral IL-17 franchise are 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. DC-806 is the lead candidate in DICE’s oral IL-17 franchise.
About DICE Therapeutics, Inc.
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